INTEGRATED BIOMEDICAL TECHNOLOGY RESEARCH RESOURCES FOR PROTEOMICS AND GLYCOMICS RELEASE DATE: July 22, 2002 PA NUMBER: PA-02-132 EXPIRATION DATE: November 1, 2003, unless reissued. National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov) Letter of intent receipt dates: January 1, May 1, September 1 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism(s) of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Center for Research Resources proposes to foster the development of improved technologies and methods for proteomics and glycomics research by sponsoring integrated Biomedical Technology Research Resources through the P41 mechanism. One way to confront the growing analytical challenges of the genome era is to pursue technology development primarily along integrated lines of inquiry rather than single technologies. This is particularly true in the field of proteomics. These integrated Research Resources will develop a range of innovative analytical tools and methods, and apply these tools to biologically significant problems. The Research Resources will also provide broad access to these integrated technologies through collaboration, service, training, and dissemination activities. While some responses to this program announcement will concentrate on core proteomics technologies, those with special expertise in analytical glycobiology are encouraged. The multiple roles of glycosylation in the structures, trafficking, and activities of proteins present a complex analytical challenge which is important to address as a component of efforts to unravel the proteome. The post-translational nature of this modification necessitates both a difference of approach and a range of specific technological and bioinformatics tools that can be integrated into the broader context of proteomics experiments. RESEARCH OBJECTIVES The Division of Biomedical Technology (DBT) of the National Center for Research Resources (NCRR) supports Biomedical Technology Research Resources through the P41 grant mechanism. Scientists at these centers conduct research to create and disseminate innovative technologies and methods applicable to a broad spectrum of biomedical research problems. The increasing complexity of the biomedical research enterprise adds urgency to the need for continued development of more fully integrated analytical technologies, deriving their focus from a line of inquiry. Proteomics is a field in which this need is both significant and easily demonstrated. It is anticipated that these integrated centers may be significantly larger and more complex than a more narrowly defined research resource. These centers may be expected to draw together the expertise of experienced investigators whose areas of specialization and established research focus will contribute to the overall goals of the project. It is not absolutely required that all participating investigators and laboratories be collocated either at a single institution or in the same local geographic area. However, because of the need for integration of technologies at a fundamental level, it is considered critical that participating investigators be in a position to work closely together in an iterative manner. This is seen as particularly important for example in the effective interfacing of analytical instrumentation. These issues should be addressed in detail in the application. The project will be administered through the principal investigator and his/her institution. Proposed integrated research resource centers should focus on the core technological and methodological problems of proteomics. Regardless of the specific experimental approaches taken in proteomics experiments, a common theme in this field is the need for synergy among three principal domains: (1) biological competencies, (2) analytical chemistry, and (3) computational tools. These domains should each inform the development of tools and methods in their counterpart areas. Accomplishing this goal in a climate of specialization demands a fundamentally collaborative approach. Within the broad scope of proteomics, there are perhaps five types of questions that are addressed in some form: (1) identification of individual proteins, (2) recognition of protein interactions, (3) relative quantitation to distinguish differential expression of proteins, (4) characterization of post- translational modifications, and (5) formulation of models based on results from components 1-4. These issues are deliberately discussed with respect to fundamental analytical challenges, rather than in relation to specific technologies, in order to emphasize the overriding importance of surmounting these obstacles, irrespective of the analytical strategy adopted to pursue those solutions. This solicitation is open to unconventional or alternative approaches. Development of complex, integrated approaches to proteomics problems will require a context within which methods development can proceed. Investigators may wish to select a model system or define a biological research topic that will serve as a framework for the technological research and development activities of the resource. Similarly, the challenges broadly stated above may be too broad for a single resource to address comprehensively. Investigators will be expected to clearly define the scope of their activities, and this definition should inform their choice of biological context, if any. Integrated research resources in proteomics will eventually be expected to have a broad-based, significant impact on a variety of biological problems, both through collaborative projects and those initiated within the resource. However, ultimately, the most important deliverables will be state-of-the-art technology and methods for proteomics research. Post-translational modification is a point of concern in the development of strategies for proteomics. Because these modifications cannot be inferred directly from gene sequence, they generally can only be characterized directly. This raises issues about sequence coverage and stoichiometry of modifications that are not presented by proteomics problems focused on protein identification. In particular, the complexity and diversity of glycosylation events significantly complicates the linkage between genetic sequence and mature, active proteins. Because glycosylation is mediated by a wide range of factors, discovery-based analytical tools that can survey the complexities of glycosylation on a system-wide basis may have significant biological impact. Apart from the obstacles presented by proteomics in the general case, glycobiology-focused proteomics, or glycomics, requires the development of novel approaches and tools directed at the special challenges of glycobiology. Strategies for separation, profiling, quantitation, and detailed characterization of carbohydrate structures are central challenges. Bioinformatics tools are needed for data handling and reduction, correlation of carbohydrate and protein information, recognizing shifts in glycoprotein microheterogeneity, and model building. Synthesis, three-dimensional structural analysis, and a variety of other carbohydrate-specific analytical tools may prove necessary to varying degrees, depending on the global strategies adopted and thematic focus of a center. Ultimately, laboratories engaged in glycomics will need the tools of mainstream proteomics, and these additional specialized capabilities as well. Because of the breadth of challenges inherent in developing effective tools in both proteomics and glycomics, we wish to encourage laboratories with special expertise in analytical glycobiology to address those technological problems that are inherent in and unique to glycomics. MECHANISM(S) OF SUPPORT This PA will use the NIH P41 award mechanism. Existing NCRR P41 research resource centers may apply through submission of an application for a competitive supplement. An application for a competing supplement cannot have a project period that extends beyond the current P41 grant period. It is anticipated that a supplemental award would result in an expansion of the scope of the main grant at the next competitive renewal. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. Applicants may request a project period of up to five years. These awards may be renewed by submission of competing-continuation applications. 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 NCRR provide support for this program, awards pursuant to this PA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. The NCRR Division of Biomedical Technology places a ceiling on Biomedical Technology Resource Center applications of $700,000 in direct costs (excluding equipment) per budget period and/or $500,000 total in equipment for the duration of the requested award. Applications exceeding these ceilings require a written waiver from the Division Director. The waiver must be requested well in advance of submission of the application, and must be included in the application, along with the scientific rationale for exceeding the ceiling. It is understood and expected that integrated research resource centers will very often require significantly greater investment than those centered on a single technology, and may also require unusually large investments in capital equipment. However, applications exceeding these ceilings without prior approval from the NCRR DBT Director will be returned without review. 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 Eligibility for Biomedical Technology Resource Center Grants is limited to those institutions located in the United States. Both profit and nonprofit organizations are eligible for support. Foreign institutions may be included as subcontracts. 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 encouraged to apply for NIH grants. SPECIAL REQUIREMENTS Applicants are encouraged to contact NCRR Program staff well in advance of the application submission date, in order to discuss the proposed research program, budget, organization of the resource, and its potential biomedical impact. These contacts help to assure that applicants have a clear understanding of current Program policies and priorities, especially with respect to any special situations, such as the inclusion of consortia, subcontracts, etc. It will also allow staff to assess responsiveness to this PA, provide appropriate guidance as needed, and provide necessary clearances to exceed budget ceilings delineated in this announcement. Applications should conform to the requirements of this PA and the BT Resource Center guidelines, found at (http://www.ncrr.nih.gov/biotech/btguide2.pdf). Biomedical Technology Research Resource centers have a five-fold mission of technology R&D, collaborative research, service, training, and dissemination. They represent a critical mass of both technological and intellectual resources assembled with the intent of exploiting advances in instrumentation and physical methods for biomedical research. These resources create critical, often unique technology and methods at the forefront of their respective fields that are applicable to a wide variety of problems in the biological sciences. This is accomplished through a synergistic interaction of technical and biological expertise, both within the resources and through intensive collaborations with other laboratories. At their best, these resources should be in an optimal position to: identify unexpected opportunities for technological advances to open new lines of biological inquiry, and appreciate which problems they may be in a position to solve by creation of new tools. This intense synergy between technology development and biological problem-solving gives the resources a fundamentally different character from that of labs engaged in investigator-initiated or other center-related projects with more narrowly defined goals. A properly constituted research resource constantly strives to provide service and training to outside investigators, and to disseminate the technology and methods it has developed. These efforts require a fundamentally outward-looking philosophy. The goal of these efforts is to, so far as is possible, achieve a broader impact on biomedical research than would be possible through the projects in which the resource can participate directly. Ultimately, this process should drive toward the widespread and routine application of the technologies being actively disseminated. Technological Research and Development: Technological R&D is most effective when it responds to emerging needs of the biomedical research community. However, the Resource Center technology must be dynamically evolving and an important area for R&D in its own right. The technological R&D or core component consists of investigations that are at the cutting edge of the technological field with a goal of increasing its usefulness in biomedical research. A minimum of three technological research projects constitutes the core section of the resource grant application. For example, these projects may involve development of new or significant modification of existing instruments or methods, development of new computer algorithms and related software or new methods to prepare samples for instrumental analysis, or development of innovative applications through the integration of existing technologies. An element of high risk (and potentially high payoff) may be present in one or more of the core projects and is appropriate for this component. Investigators should, however, present alternative approaches to solving technological problems in the event that their main conceptual thrust should prove unfeasible. The technological R&D projects to be conducted must be presented in detail. For each project describe the background, objectives, rationale, methods and procedures, significance, and facilities available to conduct the project. If research activities involve support at more than one location through a consortium/contractual arrangement, the application should provide a separate description, detailed budget and budget justification for the consortium/contractual component(s). The development of individual technologies and methods should be described in detail. In addition, the interrelationships of these technologies should be described, as well as plans for maximizing connectivity and synergy both in the technologies and between participating groups. These discussions should be placed in the context of the overall strategic goals of the center"s research program. Collaborative Research: In concert with investigators from other institutions, Resource Center staff should continuously develop new, significant applications of the resource technology in the biomedical sciences. This is best accomplished through high-quality collaborative research projects that are closely related to core technology development. These projects involve experts in the technology, usually resource personnel, working jointly with investigators outside the resource who have expertise in a particular biomedical discipline. Such efforts should lead to joint publications and, in some cases, patents. The collaborations should drive the technological R&D and the technology should significantly advance the frontiers of the collaborative research projects. In an integrated center for proteomics or glycomics, a particular biological system or problem may be adopted by the project team as a major research focus, in order to provide a framework for development of analytical technologies and strategies. If this is the case, this biological focus may be presented as a major collaboration, and may in fact dominate the initial activities of the resource. However, over time, it is expected that the resource will adopt an increasingly outward focus on a broad range of challenging biological problems that will provide both new drivers and new opportunities for technology research and development. Collaborative projects enable non-core researchers to interact with the Resource staff to pursue areas of common interest that further the Resource"s research objectives. These projects are selected for the impact they will make on the technological field as well as for advancing the frontiers of biology and medicine. For each collaborative project, describe the specific objectives: the rationale for the proposed approach to the problem, methods, and procedures to be used, the significance of the proposed work, and the impact of the expertise of the Center"s core staff along with the technology developed at the Center on the collaborative project. Provide literature citations. The collaborator"s name, institution and funding status of the project including principal investigator, grant number, and project period dates, and also the source of funds should accompany the description of the project. Collaborative projects that have already been peer-reviewed will be evaluated on how they clearly advance and stimulate technological resource development as well as advancing the frontiers of biomedical science. Those that have not been peer-reviewed should include more detail and will be evaluated for scientific merit of the research proposed. New applications should have at least four relevant collaborative projects, three of which are with investigators outside the Resource Center"s host institution. Service: Providing biomedical investigators access to a Resource"s technology constitutes the service activity. This includes making available specialized instrumentation, equipment, software and techniques, and offering consultation and technical assistance in their use. The Resource Center is expected to be acknowledged in papers resulting from all projects, including service research projects. While service is one of the key elements of the Resource, the P41 mechanism is not intended to support centers that are predominantly service oriented. It is presumed that laboratories that propose the development of technologies and analytical strategies in new applications will not be in a position to provide significant access to the broader research community until the technology has actually been developed to some degree. This may be particularly true in the case of integrated centers for proteomics, which may be inwardly focused initially. However, it is expected that these centers will make every effort to provide access to new technologies at the earliest practical time in their development. A representative sample of (no more than 20) research projects to be served by the resource must be submitted. Each project should be described in sufficient detail to allow the reviewers to evaluate the need for the resource technology in the proposed project. The user"s name and institution and funding status of the project (including principal investigator, grant number, funding source, and term) should accompany the description of the project. Training: Plans for training activities must be submitted. Examples of appropriate training activities include: special training on resource facilities to collaborators and service users of the resource on an individual basis, routine training and education on the technology or methodology through hands-on laboratory experience, seminars and lectures on a regular basis, short courses, symposia and workshops on appropriate topics that bring together researchers in multidisciplinary areas from academic institutions, hospitals and industry for discussions on the use of the resource"s technology in biomedical research. Training can be offered periodically, often in conjunction with meetings that the user community is likely to attend. Funds to support courses given for credit may not be requested. Individuals involved in the training experiences may not be paid a stipend nor may the training experience be a requirement for receipt of an academic degree. Dissemination: Plans for dissemination of the Resource"s technology, expertise or accomplishments must be submitted. Appropriate dissemination activities involve informing the scientific community about the Resource"s technology or accomplishments by: publishing articles, books, patents, newsletters, annual reports, special issues of technical journals, web pages, and press releases, presenting research results at meetings, conducting conferences, distributing software products, and transferring technologies to industry where they will be distributed widely. In resources that are developing software, emphasis should be placed on producing portable, well-documented, user-friendly software, making it readily available to the user community and providing user support. All dissemination activities must acknowledge NCRR grant support. Management and Organization A principle underlying this program is that substantial benefits in technology development and biological problem solving will accrue through successful integration of the biological, analytical, and informatics domains of the center. The application should articulate a specific organizational plan. This plan should describe anticipated interactions between key personnel in support of the overarching goals of the resource. It should also maximize synergy between the component technologies. Ultimately, a successful resource will function as a coherent whole, rather than a collection of individual technological capabilities. A separate section on resource organizational structure should address the following: Organizational Structure: Describe the organizational structure of the Resource. Indicate how the Resource will relate to the administrative structure of the grantee institution. Resource Staff Responsibilities: Describe how the principal investigator and the proposed resource staff will be organized with respect to the resource activities: technological R&D, collaborative research, provision of service, training, dissemination and general resource administration. Describe the scientific and technical expertise of the staff that will operate, maintain, and develop the Resource capabilities. Resource Operating Procedure: Describe operating procedures and policies planned for the Resource. Also describe methods for selecting collaborative research and service projects, and the instructions on how they are to acknowledge support provided by the Resource in any resulting publications. Resource Advisory Committee: The advisory committee is appointed by the principal investigator (PI) and advises the P.I. on future directions for the Resource particularly in planning additional grant applications and in setting priorities for allocation of Resource facilities. The committee chair should be knowledgeable about the Resource"s technology and the science it serves, but should not be a member of the Resource staff or a major user of the resource. Other committee membership should be balanced among scientists knowledgeable about the Resource"s technology, experts in its application to biomedical research problems and users of the technology. Committee members should be from the geographical regions served and membership should be rotated periodically. The committee chair and a majority of members should be from outside the host institution. The advisory committee should meet at least annually at the Resource Center and prepare a written report of its recommendations. This report must be supplied as part of the Resource"s annual progress report and must be available for NIH staff review during site visits. Describe the role of the resource advisory committee. For example, explain the committee"s role in advising on instrument purchases, reviewing collaborative and service projects for merit and appropriateness, and allocating instrument time. The scientific disciplines to be represented by the advisory committee should be provided. Names of committee members should also be included, if already appointed, accompanied by a brief description of their qualifications. An executive committee, perhaps a local subcommittee of the advisory committee, may be included as an adjunct to the full advisory committee as well as a medical committee if there is substantial involvement of human subjects in research projects. Funds may be requested in the consultant category of the budget to support the costs related to a resource advisory committee. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA 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: Douglas M. Sheeley, Sc.D. Division of Biomedical Technology National Center for Research Resources 6705 Rockledge Drive, MSC7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0755 FAX: (301) 480-3659 Email: sheeleyd@ncrr.nih.gov o Direct your questions about peer review issues to: Noni Byrnes, Ph.D. Center for Scientific Review 6701 Rockledge Drive, MSC7806 Bethesda, MD 20892 Telephone: (301) 435-1217 FAX: (301) 435-2327 Email: byrnesn@csr.nih.gov o Direct your questions about financial or grants management matters to: Ms. Mary Niemiec Office of Grants Management National Center for Research Resources 6705 Rockledge Drive, MSC7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0842 FAX: (301) 480-3777 Email: maryn@ncrr.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 PA 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. The letter of intent is to be sent by the appropriate date listed at the beginning of this document. The letter of intent should be sent to: Douglas M. Sheeley, Sc.D. Division of Biomedical Technology National Center for Research Resources 6705 Rockledge Drive, MSC7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0755 FAX: (301) 480-3659 Email: sheeleyd@ncrr.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. Required information, in addition to that requested in the Form PHS 398 instructions, is listed below, by section. Neither a site visit nor an applicant interview is guaranteed as part of the review of the resource grant application. The written application should be complete and stand on its own. The application should be written with the expectation that no site visit or interview will occur. Form Pages 4-5: The budget should be completed as described in the instruction sheet for Application for a Public Health Service Grant (Form PHS 398). Funds may be requested for technological R&D, training, dissemination, advisory committee meetings (in the consultant costs) and the Resource"s expenses associated with collaborative and service projects. Graduate student and postdoctoral support can be requested only if they are active participants in a core research project. The level of the requested budget should be clearly supported by the research plan. The outside investigators of collaborative and service projects must derive support for their projects from sources outside the Resource Center. The budget justification beginning on PHS Form Page 5 should include a detailed justification for key personnel. The percentage effort for each of the staff on research should be specified for a) each of the core projects, b) collaboration, and c) service in the budget justification. A detailed justification should also be supplied for the equipment requested for the Resource. Appropriate price quotes should be included for major items of equipment costing more than $25,000. An evaluation of alternative instruments or manufacturers should be included along with a discussion of the proposed procurement plan. Similar justifications should be provided for any subcontractual or consortium arrangements. Use continuation pages as needed. Section 6, Biographical Sketches should be included for key personnel for whom salary support is requested in the application and for each of the principal collaborators. Section 9, Research Plan, A-D: The page limitation specified in the PHS 398 for items A-D of the Research Plan does not apply, but applicants are reminded to be succinct as well as complete. The length of the application should be consistent with the scope of the proposed research and the number of collaborative and service projects. It is important to be concise, but there should be sufficient information about each core, collaborative, and service project to permit its evaluation. Section 9, Research Plan C: Preliminary Studies/Progress Report should include a plan that states long-term goals and overall objectives for the resource and a projected timetable for technology development. Information on factors and events contributing to the decision to create the resource and on comparable resources elsewhere should be presented. Applicants should explain in detail what makes this particular resource "unique" in terms of its intellectual and technological capabilities. For supplemental applications, a brief summary of the Resource Center"s progress should be included. Include copies of the Resource Center"s most recent annual progress report and minutes of the most recent Advisory Committee meeting in the Appendix. Section 9, Research Plan D: Research Design and Methods should include a discussion of the proposed research in each of the three major resource activities: technological R&D, collaborative research, and service. Indicate the relative emphasis to be given to these activities and explain the proposed division of effort. Plans for training and dissemination should also be presented. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. All new, competing renewal, and supplemental P41 applications are due on the February 1, June 1, and October 1 dates. 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: Contact the NCRR 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 NCRR staff that the NCRR will accept your application for consideration for award, and, 3) Identify, in a cover letter sent with the application, the staff member 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 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) APPLICATION PROCESSING: Applications must be received by or mailed before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. 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 application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique 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 second level review by the appropriate advisory council REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of your 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 your application"s overall score, weighting them as appropriate for each application. Your 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, you may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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, your application will also be reviewed with respect to the following: PROTECTIONS: 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. INCLUSION: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) DATA SHARING: The NIH encourages the timely dissemination of research tools and results, in support of further research and development. The NIH has issued a document that addresses these concerns (http://www.ott.nih.gov/policy/rt_guide_final.html). Dissemination of the technologies and methods which are developed, as well as appropriate training for colleagues, are critical components of Biomedical Technology Research Resources. Specific plans for dissemination of tools developed as well as scientific results should be an integral part of any application. The increasing size and complexity of proteomic data sets presents challenges with respect to data sharing. In addition, it is possible that extensive and potentially very valuable databases may be developed by these centers in the course of their work. The disposition of these data, accessibility, and curation, particularly vis- -vis existing or parallel data repositories should be addressed. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA: P41-supported research resources serve a unique purpose in the broad context of NIH-funded research. This specialized role requires a distinct set of qualities that can be defined largely in terms of their resulting impact on the biomedical sciences. In addition to the fundamental NIH-wide criteria described above, these resource center applications are reviewed according to criteria that focus on the quality of the five component activities of the proposed center, as well as its potential for broad biomedical impact. Review guidelines can be found at http://www.ncrr.nih.gov/biotech/p41revguidelines07082002.pdf. It is recommended that applicants familiarize themselves with that material as they prepare their proposals. As indicated above, the proposal should be prepared with the presumption that there will be no site visit or interview. The proposal should stand on its own. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://grants.nih.gov/grants/stem_cells.htm and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. 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.health.gov/healthypeople/. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.371, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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