RFA-GM-04-001: LARGE-SCALE COLLABORATIVE PROJECT AWARD RENEWALS

Department of Health
and Human Services (HHS)

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LARGE-SCALE COLLABORATIVE PROJECT AWARD RENEWALS RELEASE DATE: December 17, 2003 RFA Number: RFA-GM-04-001 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of General Medical Sciences (NIGMS) (http://www.nigms.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.859 APPLICATION RECEIPT DATES: October 19, 2004 for FY 2005 Awards October 19, 2005 for FY 2006 Awards October 19, 2007 for FY 2008 Awards 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 Special Requirements o Where to send Inquiries o Submitting an Application o Peer Review Process o Review Criteria for the Overall Project o Review Criteria for Core Resources o Review Criteria for Bridging and Pilot Projects o Additional Review Criteria for All Components o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The purpose of this solicitation is to invite the submission of renewal applications and to describe application, review, and award procedures for the renewal of large-scale collaborative project awards (commonly called glue grants , http://www.nigms.nih.gov/funding/gluegrants.html). This announcement applies to awards whose support from the National Institute of General Medical Sciences (NIGMS) for the Phase II application began in FY 2000, FY 2001, and FY 2003 (no awards were made in FY 2002). [New applications for large-scale collaborative project awards are not currently being accepted by NIGMS and are not part of this request for applications (RFA). NIGMS may consider re-opening this program for new awards at a future date.] NIGMS issued the first RFA for large-scale collaborative project awards in 1999, and the program was reannounced in each of the next three years. One award was made in FY 2000, three awards were made in FY 2001, and one award was made in FY 2003. Each of these awards was made for five years. Currently active large-scale collaborative project awards are eligible to compete for one renewal period of up to five additional years of support. Critical elements of these renewal applications will include evidence that a highly integrated and functioning team has been established; that good progress is being made; that the progress makes feasible accomplishment of the final goals in the next time period; that results have been achieved that could not have been accomplished by individual efforts alone; that plans for the next project period are compelling; and that plans have been made to accommodate the termination of NIGMS support at the end of that period. Overall, the applications should describe the proposed and unanticipated challenges that were met, how the project has evolved, where it stands currently, and how the final phase will be achieved. RESEARCH OBJECTIVES The NIGMS held several meetings with members of the scientific community in FY 1998 and 1999 to assess the needs and opportunities for future research in areas supported by NIGMS. A common theme that emerged from these meetings was the strongly felt need of the academic community to have an award mechanism that facilitated the interaction of independently funded scientists from the same and different disciplines to work together as teams on common problems in biomedical science. It appeared that a new direction in the conduct of science was emerging and the large-scale collaborative project awards were originated as a new mechanism to meet this need. The suggestion was made to call these new awards glue grants because they were meant to glue together independently funded scientists. The general parameters for these awards were as follows and remain applicable to the applications: the solution of a major question in biomedical science where a synthesis of information from participating laboratories is necessary; each of the participating investigators has to hold competitive independent support in the area of the glue grant; the funds are meant to support only collaborative and integrative activities; and the biological question has to fall within the mission of NIGMS (see http://www.nigms.nih.gov/about/overview.html for scope of NIGMS interests). The goals of this program remain the same: to enable the solution of major problems in biomedical research and to facilitate the next evolutionary stage of integrative biomedical science. It is expected that the research problem selected for the originally funded application will remain the focus of the renewal application. The renewal application should provide a detailed explanation of the proposed project. It should explain how the project has evolved over time and where it stands on the path to achieving its final goals. It should also include specific intermediate goals (milestones) for the next period of support and a timeline for their accomplishment. Progress made on the overall goals of the collaborative projects and on the individual elements will be a major factor in the assessment of the renewal applications, and future plans should build on the progress to date. Not only must adequate progress be demonstrated, but advances that could not have been achieved with purely individual efforts must be clearly articulated. The effective functioning of the collaborative project team must be made clear. One assessment of the team’s functioning will be the challenges met, the decisions made, and changes in direction implemented. A special feature of the renewal applications will be the plans for these consortia beyond the renewal funding period. Large-scale collaborative project awards have a maximum limit of ten years of support (five years for the original award and five years for the renewal period). The renewal application must describe plans for bringing this activity to an orderly conclusion or for continuation through other sources of support. In addition, these awards may have generated research resources that need to be continued beyond the life of the large-scale project. Plans for long-term maintenance and management of such resources must be included. Thus, the plans beyond year ten of these collaborative projects will receive close scrutiny by the scientific review group, by the advisory council, and by institute staff in reaching their recommendations. MECHANISM OF SUPPORT This RFA will use the NIH Specialized Center (U54, Cooperative Agreements) award mechanism. As an applicant you will be responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award dates are September 2005, September 2006, and September 2008, as appropriate. Amended renewal applications will not be accepted. This RFA uses just-in-time concepts. Follow the instructions for non- modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm. The NIH U54 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." NIGMS does not plan to continue large-scale cooperative project awards beyond one renewal period. However, the institute will consider applications for our usual award mechanisms, such as R01 applications, to continue research resources generated by these consortia beyond the lifetime of the large-scale award. FUNDS AVAILABLE NIGMS intends to commit the funds necessary for the competing continuation of all ongoing large-scale collaborative project awards. An applicant may request a project period of up to five years and a budget for direct costs of up to $5M per year. Because the nature and scope of the proposed research will vary from application to application, the size and duration of each award may also vary. Although the financial plans of the NIGMS provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of highly meritorious applications. ELIGIBLE INSTITUTIONS You may submit a competing-continuation application in response to this RFA if your institution was awarded a large-scale collaborative project award from NIGMS in FY 2000, FY 2001, or FY 2003, or if, with the approval of NIGMS, an awarded large-scale collaborative project award was or will be transferred to your institution due to a change in Principal Investigator or change in institution for the Principal Investigator. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The major research activity of the Principal Investigator (PI) must be in the research area of the collaborative project application, and the PI is expected to commit an appropriate level of effort to directing and managing the operation of the project; a substantial level of effort will be necessary to manage projects of the largest magnitude. Changes in PI or in lead institution for a large-scale collaborative project award must be approved by the NIGMS program director for the award in advance. SPECIAL REQUIREMENTS COLLABORATIVE PROJECT ORGANIZATION AND RESOURCES: The elements and organization of a large-scale collaborative project remain the same. The organizational structure of the collaborative project may have a variety of forms depending on the needs of the research problem being addressed. Support to Individual Laboratories Investigators are expected to bring their own support for their individual laboratories to the collaborative project. The large-scale collaborative project award mechanism is not meant to support R01-type projects. It is recognized, however, that in some cases, there may be a need for special efforts in the individual laboratories of the participating investigators requiring additional funding to enhance the efforts of the consortium or to integrate the individual work of a participating investigator with the consortium. Two mechanisms, bridging projects and pilot projects, have been designated for this purpose. Bridging Projects Applications may propose new or continuations of existing bridging projects to support work in the laboratories of the individual participating investigators when that work is intended to provide either a bridging function to more fully integrate the individual work with the collaborative project or a service function to develop data or resources or technology to benefit the overall glue project. Requests for continuation of existing bridging projects must be justified in terms of progress to date as well as future plans. Bridging projects should add to or bridge the intellectual and technological approaches of the collaborative project. They are not meant to be stand-alone research efforts but are to be efforts that tie, or enhance the contribution of, the independent work and expertise of the participating investigator to the large-scale collaborative project. A new bridging project should extend the participating investigator’s independent work in a new direction(s). A new bridging project to do more of what the investigator is already doing should be considered only if there are extraordinary circumstances that make it essential for the effective functioning of the large-scale project. If the participating investigator’s work is already closely tied to the large- scale project, a bridging project should not be needed. Stand-alone new research projects should not be submitted for bridging projects. If a bridging project could be submitted as a regular R01 application, it should not be requested as a bridging project, even if it adds value to the large-scale project. Judgment will be required on the part of applicants and reviewers alike to distinguish between projects that are appropriate for support by consortium resources and those that should be submitted and reviewed as regular research grants (R01s). Pilot Projects New pilot projects may be requested in the renewal application, but require strong justification keeping in mind that the award will be in a final renewal period. Pilot projects are intended for investigators who do not hold current independent support in the area of the collaborative project in order to add elements where gaps exist, or to add investigators with critical knowledge or expertise but who do not have a research background in the area of the collaborative project. These pilot projects must not exceed $75,000 in annual direct costs and must be limited to no more than three pilot projects per year per large-scale collaborative project. The pilot project should be of sufficient scope to qualify as a stand-alone research effort. It is primarily intended to allow the collaborative project to add investigators outside the scientific mainstream of the project area in a mode that will allow them to develop independent research in the area of the collaborative project. Applicants must explain why the expertise of the PI of the pilot project is needed for the large-scale project and how the pilot project will contribute directly to accomplishing the aims of the large-scale project. While funding for a pilot project may run for five years, at the discretion of the steering committee, it is expected that the PI of a pilot project will seek R01 funding during the period of the collaborative project, based on the results obtained from the pilot project. Cores Core resources may be requested to speed progress on the scientific goals of the project or to add additional capability to the collaborative project by adding new or improved technology or by standardizing data among different research teams. Requests for core resources must be strongly justified in terms of value to achieve the goals of the project, value to increase the synergy of the collaborative project, and cost effectiveness. Requests for continuing existing core resources must also be justified in terms of progress and results achieved to date. It is expected that each large-scale collaborative project will request core resources for continuing information collection, coordination, and dissemination. A bioinformatics core to include assembly and organization of data for querying, developing tools for its querying, computation, and modeling may be requested as a separate core or be combined with the information dissemination core. Administrative Management Plan Each large-scale collaborative project award application must provide an administrative management plan that includes: an overall description of the organization of the large-scale project, the make up and responsibilities of the steering committee (including how often and by what means they will meet), and how information will flow within the project and how it will be integrated into the solution of the biological problem being addressed. It should outline the policies and procedures whereby participating and non-participating investigators can have access to the collaborative project resources. The application should address the mechanism that will be followed to add new participating investigators and delete members whose association with the project has not been productive. The plan should include proposed methods for information dissemination to the scientific community, as well as to consortium members. Furthermore, each large- scale collaborative project should discuss the mechanism whereby concerns of the scientific community directly affected by the project will be considered and responded to. A discussion of scientific community views will be part of the agenda for annual meetings of the steering committee with the advisory committee. Project Management Plan Each large-scale collaborative project award application must include a project management plan, including an ongoing evaluation plan, to ensure consistent forward progress of the project. Each collaborative project will define, at a minimum, yearly milestones, developed by the PI in consultation with the steering committee. Those receiving awards will have the opportunity to modify these milestones at the time of their awards, with the concurrence of NIGMS. It is expected that the milestones will be adjusted annually at the award anniversary dates, both to incorporate a team's scientific accomplishments and progress in the field in general and to reflect the recommendations of the advisory committee. The NIGMS program director responsible for the large-scale collaborative project may include outside consultants in the annual progress review and may recommend reducing or withholding funds, or termination of the award, for failure to meet milestones. A report by the NIGMS program director on the collaborative project's progress and any recommendations to modify funding will be made annually to the National Advisory General Medical Sciences Council. Plan for Handling Intellectual Property and Sharing of Research Resources: The nature of large-scale collaborative projects is to move entire fields forward. NIGMS intends that, to the extent possible, all investigators within a field have equal access to research resources generated by these collaborative projects. To address this interest in assuring that research resources are accessible, NIGMS requires applicants who respond to this RFA to (1) submit a plan for sharing the research resources generated through the award and list the collaborative project’s record to date on the timing of release of shared research resources; and (2) address how they have exercised intellectual property rights and describe plans for the future, should any be generated through this award, while making such research resources available to the broader scientific community. It is expected that resources shared will include, among others, data and information, materials such as cell lines and mutant animals, and novel reagents and techniques. The sharing of research resources plan and intellectual property plan must make unique research resources readily available for research purposes to qualified individuals within the scientific community in accordance with the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps/) and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, December 1999 (http://www.ott.nih.gov/policy/rt_guide_final.html and http://ott.od.nih.gov/NewPages/64FR72090.pdf). These documents also define terms, parties, and responsibilities; prescribe the order of disposition of rights; prescribe a chronology of reporting requirements; and delineate the basis for and extent of government actions to retain rights. Patent rights clauses may be found at 37 CFR Part 401.14 and are accessible from the Interagency Edison web page, http://www.iedison.gov. As noted below (see Peer Review Process and Review Criteria), the scientific review group will comment, as appropriate, on the adequacy and feasibility of the sharing of research resources plan and the intellectual property plan, as well as the consortium’s record to date. Because dissemination is a critical aspect and fundamental purpose of this RFA, evidence of the commitment of the large-scale project leadership to the sharing of research resources and to effective management of intellectual property issues will be part of the scientific merit review. The adequacy and record to date of the proposed sharing plans will be an important factor in the Institute’s decision to make an award. Furthermore, the proposed sharing plans, after negotiation with the applicant when necessary, will be made a condition of the award. Evaluation of annual progress reports and of subsequent renewal applications will include an assessment of the effectiveness of the sharing of research resources. Disclosures: Members of the large-scale collaborative project must disclose in the application their ties to profit-making organizations to aid the administration of the collaborative project and to assist the NIH review process in avoiding conflict-of-interest situations. Applicants are also reminded that the grantee institution is required to disclose each subject invention to the Federal Agency providing research funds within two months after the inventor discloses it in writing to grantee institution personnel responsible for patent matters. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD: The following section represents Terms and Conditions that will be incorporated into the award statement and will be provided to the PI, as well as to the appropriate institutional official, at the time of award. The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies: The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during performance of the activities. Under the cooperative agreement mechanism, the NIH’s purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and primary responsibility resides with the awardees for the project as a whole. 1. Principal Investigator Responsibilities: The PI is the scientist who assembles the large-scale collaborative project and is responsible for submitting the application in response to this RFA and for performance of the project. The PI will coordinate project activities scientifically and administratively originating from the awardee institution. The PI will have the overall responsibility for the scientific and technical direction and the administration and overall operation of the large-scale collaborative project. The PI will chair the steering committee. As for all participating investigators, the PI must abide by the operating rules and guidelines developed by the steering committee. The PI will agree to accept participation of NIGMS staff in those aspects of management of the project described under "NIGMS Program Director Responsibilities." He/she will also ensure the timely dissemination of information generated by the large-scale collaborative project to both the project members and the scientific public. Awardees will retain custody of and have primary rights to the research resources developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies, and also subject to the approved sharing of research resources plan and intellectual property plan to make unique research resources readily available for research purposes to qualified individuals within the scientific community in accordance with the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps/) and the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice, December 1999 (http://www.ott.nih.gov/policy/rt_guide_final.html and http://ott.od.nih.gov/NewPages/64FR72090.pdf). 2. Participating Investigator Responsibilities: The participating investigators are those scientists holding externally peer reviewed grant support in the area of the project and who are involved with and committed to the goals of the project. It is expected that the majority will be funded through research grants supported by NIGMS, other NIH institutes and centers, and other governmental and private agencies. Exceptions to the rule of external funding may include participating investigators from industry, foreign institutions or allied fields not traditionally supported by the NIH (e.g., physics and mathematics). Principal Investigators of pilot projects are also included as participating investigators. Participating investigators will work with the PI, the steering committee, and the other members of the large-scale collaborative project to set goals and develop working procedures; they must agree to support the goals of the project and to abide by the operating guidelines and procedures established for the project. They must provide a listing of organizational resources that will be committed to the project. Participating investigators will be actively involved in the project and interactive with the other members of the project. During the period of the award, a participating investigator whose independent research support terminates may continue as a participating investigator at the discretion of the steering committee and with the approval of the NIGMS program director. However, funds from this award are not to be used to support the independent research of such an investigator. It is expected that new participating investigators will be added to the collaborative project over the period of the award as deemed appropriate by the PI and steering committee and with the approval of the NIGMS program director; these additions will be reported in the annual progress report. 3. NIGMS Program Director Responsibilities: The NIGMS program director will be responsible for the normal stewardship of the award. In addition, s/he will serve as a voting member of the steering committee, attending all meetings, and will have substantial programmatic involvement. In addition to having all of the duties and responsibilities of a steering committee member, the NIGMS program director will facilitate interactions among the steering committee and the advisory committee and NIGMS, and will provide advice and guidance to assure that the large-scale-collaborative project adheres to the NIH and NIGMS rules and regulations. The NIGMS program director will facilitate communication with the scientific community directly affected by the collaborative project and will assure that the steering committee and the advisory committee address issues and concerns raised by the community. Additional responsibilities may be negotiated at the time of award depending on the individual characteristics of the awards to be made. 4. Steering Committee Responsibilities: A steering committee will continue to serve as the governing board of each large-scale collaborative project and participate in setting direction, policies, and operating procedures. Membership will include the PI, as well as other scientists and administrators drawn from the staff and participating investigators of the project, sufficient in breadth and balance to be representative of the overall project. Current members may continue and additional or replacement members will be selected by the PI in consultation with the steering committee and with the approval of the NIGMS program director. The steering committee will work with the PI to establish the scientific and technical direction of the project, develop common guidelines and procedures, establish rules for access to resources of the project, deal with intellectual property issues, and participate in the process of developing a cohesive group. The steering committee will develop a policy regarding disclosure of ties between scientists and for-profit organizations to aid the project in avoiding conflict-of-interest situations. The steering committee will monitor bridging projects, core resources, and pilot projects for progress and efficiency, and recommend modification of support and addition/deletion of these activities as needed to facilitate progress on the goals of the large-scale collaborative project. An NIGMS program director will serve as a voting member of the steering committee and attend its meetings. The steering committee will meet annually with the advisory committee, as described below. 5. Advisory Committee Responsibilities: The advisory committee will continue in its role of advising the PI and steering committee. It will be composed of a panel of a minimum of three scientists not otherwise associated with the large-scale collaborative project. The members will be appointed by the PI in consultation with the steering committee, and with the approval of the NIGMS program director. The NIGMS program director will attend the meetings of the advisory committee as a member of the steering committee but will not actually be a member of the advisory committee. The advisory committee will meet at least once a year immediately prior to the submission of the annual progress report to provide advice to the PI and steering committee of the large-scale collaborative project about meeting its goals and to comment on plans for future directions. The advisory committee will raise issues for consideration by the PI and the steering committee and will comment on the appropriateness of the level of NIGMS support to achieve the goals of the project. The advisory committee will also comment on the impact of the collaborative project on the relevant scientific communities. 5. Milestones and Evaluations: It is expected that milestones will be adjusted annually at the award anniversary dates, both to incorporate a group's scientific accomplishments and progress in the field in general, as well as to reflect the recommendations of the advisory committee. In accordance with the procedure described above, the NIGMS program director may recommend to the Director, NIGMS, augmenting any subproject or core facility or reducing or withholding funds for any subproject or core facility that substantially fails to meet its milestones or to remain state of the art. The Director, NIGMS, retains the right to call a meeting of advisors, most likely members of the National Advisory General Medical Sciences Council or their designee(s), at any time to provide advice on the scientific progress of a large-scale collaborative project. It is anticipated that such a group of advisors may want to attend a meeting of the project advisory committee as part of its fact-finding mission. 6. Arbitration Process: Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIGMS may be brought to arbitration. An arbitration panel will be convened by NIH. It will be composed of three members: a designee of the steering committee without NIH staff voting, one NIGMS designee, and a third designee with expertise in the relevant area who is chosen by the other two. The decision of the arbitration panel, by majority vote, will be binding. This special arbitration procedure in no way affects the right of an awardee to appeal an adverse action in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. 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: Dr. Michael E. Rogers Division of Pharmacology, Physiology and Biological Chemistry National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-3827 FAX: (301) 480-2802 Email: rogersm@nigms.nih.gov Dr. James C. Cassatt Division of Cell Biology and Biophysics National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-0828 FAX: (301) 480-2004 Email: cassattj@nigms.nih.gov Dr. Judith H. Greenberg Division of Genetics and Developmental Biology National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-0943 FAX: (301) 480-2228 Email: greenbej@nigms.nih.gov Direct your questions about peer review issues to: Dr. Helen R. Sunshine Office of Scientific Review National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-2881 FAX: (301) 480-8506 Email: sunshinh@nigms.nih.gov Direct inquiries regarding fiscal matters to: Mr. Joseph Ellis Chief, Grants Management Office National Institute of General Medical Sciences 45 Center Drive, MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5510 FAX: (301) 480-1969 Email: ellisj@nigms.nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the most recent PHS 398 research grant application instructions and forms (currently rev. 5/2001). Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/ . The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document 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. SUPPLEMENTARY INSTRUCTIONS: Applications in response to this RFA should consist of an application that, in addition to or in lieu of part of the items requested in the PHS 398, includes: Application face page. Complete all items. This is page 1; number succeeding pages consecutively. Abstract of Research Plan. On page 2, describe briefly the proposed large-scale-collaborative research project. List all key personnel involved in the collaborative project; use a continuation page as needed. Table of Contents. Prepare a detailed Table of Contents that includes all elements of the application. Use numeric pagination only. The major areas to be listed in the Table of Contents appear below in capital letters. Units should be presented in the order in which they appear in the application. Under Research Plan, identify each component core with a capital letter (A, B, C), as well as title, and provide the name of the core director. BUDGET ESTIMATES: Specific examples of allowable costs that may be requested include: Salaries for the PI, members of the steering committee, participating investigators, and technical and support personnel commensurate with their level of effort in the large-scale collaborative project. Although a substantial level of effort is expected for the PI, NIGMS has not set minimum levels of effort; however, the appropriateness of the level of effort of the PI will be a factor in the assessment of scientific merit and in the Institute's funding selections. The level of effort and commitment to the collaborative project of the members of the steering committee will also factor into the assessment of scientific merit as well as the Institute's funding decision. Bridging projects to the laboratories of participating investigators. Pilot projects to investigators without current independent research support in the area. These subprojects must not exceed $75,000 in annual direct costs and must be limited to no more than three such projects per application. Travel of personnel, which may include technicians, predoctoral students, postdoctoral fellows, and investigators, to different laboratories to gain specialized expertise. Travel to and conduct of regular meetings of the steering committee and regular meetings of the participating investigators. Core facilities (examples: instrumentation, genomics, proteomics, model organism, or high-throughput assay cores). Electronic media cores to allow participation of off-site laboratories and/or the means necessary to establish collaboratory capabilities and to disseminate information. Travel to and conduct of regular meetings of an advisory committee. In addition to the overall budget, include a separate budget for each bridging project and pilot project and each core resource. Applications for large-scale collaborative project awards may not request more than $5 million in annual direct costs (exclusive of subcontract indirect costs requested as a direct cost by the applicant organization, but including all equipment) for any year of the award. Salaries for support personnel required for coordination and maintenance of the project, such as secretaries, may also be included as necessary in an administrative core. Composite budget. Use Form Page 4, "DETAILED BUDGET FOR INITIAL BUDGET PERIOD," of Form PHS 398 to present the total budget for all requested support for the first year. For each category such as "Personnel," Equipment," etc., give the amount requested for each core unit and each component project, with subtotals. For consortium arrangements involving other institutions or organizations, include total (direct and facilities and administration) costs associated with such third- party participation in the "Consortium/Contractual Costs" category. Note: each participating consortium/contractual organization must submit a separate composite budget for both the initial budget period (using Form Page 4) and the entire proposed project period (using Form page 5). Costs for purchased services should be itemized under "Other Expenses." Use Form Page 5, "BUDGET FOR ENTIRE PROPOSED PROJECT PERIOD," of Form PHS 398 to prepare a budget, by category, which provides totals for each year of requested support. Requests for any increases in succeeding years must be justified in the individual component subprojects (bridging projects and pilot projects) and core unit budgets. Individual component core and research budgets. Place the budgets for consortium components, cores, bridging projects, and pilot projects immediately prior to the description of the relevant individual component. For the 06 year budgets of each of the cores and projects, use Form Page 4 of the PHS 398. Use Form Page 5 of the PHS 398 to report the budgets of each of the projects and cores for entire project period (years 06-10). Budget justifications and explanations. Describe the specific functions, including the level of effort, of all key personnel, including consultants, collaborators, and technical staff. Provide justifications for requested equipment. For years 07-10 of the project, justify any significant increases or decreases in any category over the 06 year budget. BIOGRAPHICAL SKETCHES AND LETTERS OF COMMITMENT: Biographical sketches must be included for all participating investigators along with one page letters of commitment indicating their willingness to follow guidelines and procedures established for the large-scale collaborative project. For participating investigators who are continuing from the original funding period, include a paragraph concisely stating the role and interaction of the investigator with the large-scale project during the original period. For all participating investigators, including the PI, heads of core resources, and Principal Investigators of bridging and pilot projects, provide a listing of all other support; support for other investigators such as postdoctoral students should not be listed. Highlight the relevant grant support that allows participating investigators to be part of the large-scale collaborative project. Provide the specific aims of the project and describe in sufficient detail for evaluation of the relationship of the funded grant to the goals of the proposed large-scale project. RESEARCH ENVIRONMENT: Complete the "Resources" page of PHS 398 for the overall large-scale collaborative project, including both the host institution and any participating institutions. Briefly describe the features of the institutional environment(s) that are relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as clinical and laboratory facilities, participating and affiliated units, patient populations, geographical distribution of space and personnel, and consultative resources. PARTICIPANT AFFILIATIONS: Applications should include a separate cover sheet that lists 1) all participants, including consultants and private sector alliances, 2) all the institutional affiliations for each participant, 3) their roles on the project and whether new or continuing, and 4) the percent effort listed separately for each role. This added requirement will facilitate the review of applications. RESEARCH PLAN: The NIGMS wishes to provide applicants with the flexibility to organize large-scale collaborative projects in the manner which best facilitates progress on the project being pursued. Therefore, applicants may organize and present their large-scale collaborative project applications strictly using the straightforward format that follows, or may use alternate combined formats for some parts of the application, as described below. Required components of all applications are the program summary; progress report; administrative and program management plans; a plan for data sharing and intellectual property; Cores A (administrative) and B (information dissemination and data coordinating); and responses to the bioinformatics questions listed below (see Core Resource C Bioinformatics Core) if the optional bioinformatics core is utilized. If desired, Core B may be may be combined with an optional bioinformatics core. The program summary and the progress report may be combined. The Progress Report section must include the overall progress report as well as summary progress reports for the individual elements and discussion of how progress on the individual elements have contributed to the success of the overall collaborative project. The remainder of the Research Plan may be organized as deemed appropriate, keeping in mind that the major purpose of a large-scale collaborative project award is to provide resources to enable collaboration rather than primary research support. For example, the scientific cores and bridging projects may be presented in a combined or more integrated fashion. When this, or a different alternate format from that outlined below is used, applicants should explain, in the program summary, why a different organizational structure is proposed. Any combined unit may not exceed the sum of the page limits that would have been allowed for the individual pieces of the unit. For example, if two bridging projects were submitted as a combined unit, the page limit for the combined unit would be twice that for one bridging project. In all cases, the Research Plan, including the required components, may not exceed 180 pages. Program Summary (Required) Describe the goals and operation of the large-scale project. Explain what major biological problem is being solved and how the approach of using a large-scale collaborative agreement is critical to its solution. Explain how progress made and lessons learned have affected your choices of approaches selected for the next and final period of support. Discuss the range of scientific expertise to be used to address the research problem. Explain the interactions that will occur between investigators at the host site and at the participating sites. Explain how each element of the large-scale collaborative project will contribute to a cohesive overall program. Explain the programmatic value of the core resources, bridging projects, and pilot projects. Explain how the information coming from the collaborative project and the laboratories of the participating investigators will be integrated into a comprehensive whole. Discuss how and when information and other research resources generated by the collaborative projects will be disseminated to the scientific public. Explain why the ultimate goals of this collaborative project could not be achieved simply by support of individual investigators. Progress Report (Required) Present an overall summary of progress since the inception of the collaborative project that has been made on the goals of the large- scale collaborative project award and overall summaries of progress for each of the individual elements, including original elements that are not included for the renewal period. Describe both the accomplishments of the large-scale project and the impact they have had within the consortium and on the larger relevant scientific community. Explain how progress made thus far has moved the field forward and has brought the ultimate goal of the consortium within reach. Highlight progress that could not have been achieved by individual investigator efforts alone. Delineate new research resources produced by the consortium that are now available to the research community. Provide measures of the impact of those resources. For the individual element progress reports, list the major accomplishments of each project element and indicate its impact on the progress and cohesiveness of the overall effort. Include web hyperlinks to web sites and databases that are products of research. These will be treated like publications. Reviewers may access these sites to assess their quality and impact. Sufficient description of these research resources and their content should be included in the application text for a summary evaluation. Administrative Management Plan (Required) Describe the structure, organization, and operation of the project and explain why and how this plan has evolved over the period of support. Discuss changes that have been made during the course of the project, including what elements have been dropped and what elements have been added. Describe the organizational framework and provide an organizational chart. Also describe how information will flow within the collaborative project. Explain the role of the steering committee in making administrative management decisions. Discuss arrangements between the collaborating institutions that are important to effective operation of the large-scale collaborative project. Detail the usage of the core resources by the participating investigators. Include any outreach efforts to provide access to the core resources to investigators outside the collaborative project. Explain how decisions will be made to add/delete participating investigators and to respond to changes in short term goals necessitated by research findings. Discuss how the views of the scientific community that are impacted by the collaborative project will be considered. Project Management Plan (Required) Present a project management plan, including milestones, to keep the collaborative project moving forward and on track. Define both yearly milestones and what you expect to have been accomplished at the end of the last period of support. Explain the past and planned role of the steering committee in project management. Explain how progress in the bridging projects and pilot projects and efficiency of the core resources will be tracked. Include an evaluation plan to determine how the collaborative project is progressing. Discuss the plan for evolving milestones. Explain how the advisory committee will be used in updating the project management plan. Any new members of the advisory committee for the renewal period should not be contacted or selected until an award has been made and the names of prospective new members should not be included in the application.) Plan for Termination after Final Period of Support (Required) Describe how the NIGMS ten-year limit on funding for a large-scale collaborative award will affect conduct of the award during the final period of support. Present the plan for an orderly termination of the project and how support will be sought if the project or some part of it is intended for continuation. Delineate research resources generated by the large-scale project that would be valuable to continue beyond the life of the large-scale award and the plan for support of these resources. The program summary, progress report, administrative management plan, project management plan, and the plan for termination sections have an aggregate page limit of 50 pages. Page limits for other sections are given within each section and a summary follows at the end. Investigators should endeavor to be clear and concise. Plan for Handling Intellectual Property and Sharing of Research Resources (Required three-page limit) List and comment on how the sharing of research resources and intellectual property issues has been handled in the first period of support, specifically indicating the resources that have been shared and the timing of their release. For each element below, indicate if this is a change from the initial period of support. The PI and steering committee should (1) present their plan for providing access to the research resources generated by the large-scale collaborative project to the members of the project and the scientific public; research resources include, among others, data and information, materials such as cell lines and mutant animals, and novel reagents and techniques; (2) address if or how intellectual property rights will be exercised; (3) discuss guidelines for licensing of joint inventions; (4) discuss procedures for settling of intellectual property disputes; (5) discuss the existence of any pre-existing intellectual property rights, including options to for-profit research sponsors; and (6) propose a plan for disseminating the research resources developed under this RFA. Core Resource A: Administrative Core (Required five-page limit) This core must be directed by the PI. Include the objectives of the core, a description of its staffing, and services to be provided to other core resources and to the participating investigators. Describe any changes that were made during the first period of support and their rationale. Communicating the objectives of the collaborative project and fostering opportunities for collaboration are encouraged. Expenses associated with the operation of the steering committee, meetings of all or subgroups of the participating investigators, and meetings and operation of the advisory committee would fall under the administrative core. Core Resource B: Information and Dissemination and Data Coordinating Core (Required five-page limit) Dissemination of information on techniques, scientific findings, and methodologies is a vital component of each large-scale collaborative project. Computer technology, print media, and telecommunications are relevant. Describe the staffing (including a Core Director, as well as any professional or technical personnel and their duties), facilities, and resources that will be devoted to this goal. Describe any changes that were made during the first period of support and their rationale. Indicate plans to make results of research or other unique features of the collaborative project available to as wide an audience as possible. Describe how data generated by the core resources and the participating investigators will be processed into the information to be disseminated. Discuss plans and timing for dissemination of published and unpublished data. Core Resource C: Bioinformatics Core (optional and may be combined with Core B)(15-page limit) A bioinformatics core to include assembly and organization of data for querying and developing tools for its querying, computation, and modeling may be requested as a separate core or be combined with the information dissemination core (combining the page limits of each for a maximum of 20 pages). The policies with respect to future dissemination of data and computational tools should be explained in the proposal and it is recommended, though not required for the renewal applications, that they conform to the following principles: It is recommended that: computational tools developed for analysis, visualization, or modeling the data should be freely shared with the scientific community as well as the annotated source code; others should be free to modify the source code and share the modifications with each other; and that the code should be made available to be incorporated into commercial products. The core description must include answers to the following queries, whether a separate core or combined with the information dissemination and data coordinating core. For each, describe any changes that were made during the first period. o What are the data release policies and what are the associated intellectual property issues? o How have the data been made available to the scientific community? Is there browser access, formats for downloading complete data sets, on-line computational aids, etc.? Will this change for the next phase of the project? o What is the nature and structure of the data? Describe the work to date and the projected plans for ontologies, schema, or other data models. o What is the underlying structure of the database, e.g., relational, object-oriented, etc.? Will this be continued? o What is the mechanism to date and the projected mechanism for communication (both computational and human) between the distributed sites and the database managers? Are there data liaisons? o What are the key interacting databases? How are the data be linked? What are the plans for modifying or enhancing those linkages? o How is progress made available to the public, e.g., are lists of the systems being analyzed made available? Will the same arrangement continue or be modified during the next phase of the project? o What experience in bioinformatics is available in the group and what resources can the consortium draw on? Compare the qualifications and experience of the bioinformatics team you expect to have in the next phase with the team that you started the project with. o How has the bioinformatics plan changed and evolved over the initial period of support? Core D: Scientific Resource Core(s) (Optional - ten-page limit per core) Provide specific titles for any proposed scientific resource cores (e.g., instrumentation, genomics, proteomics, model organism, or high- throughput assay), along with a designated Core Director who possesses expertise in the area of each core. Describe the professional and technical staff to be involved in the core(s) and their duties. Include plans to utilize the core(s), such as services that will be provided and to whom and their bearing on productivity and quality of the collaborative research effort. For continuing cores, discuss how the direction, management and use of the core has changed and evolved over the initial period of support. Bridging Projects (Optional five-page limit for each) Bridging projects will support work in the laboratories of the participating investigators. Indicate whether this is a new or continuing bridging project. For continuing projects, report progress that has been made and discuss how the project has changed from and builds on the initial period of support. For new and continuing projects, describe the research proposed in the bridging project and explain how this work more fully integrates the participating investigator’s independently-supported work into the large-scale collaborative project or provides a necessary service function or technology to the collaborative project. For all proposed projects, the underlying rationale and potential impact of the studies should be specifically addressed. Projects must be described in sufficient detail to permit evaluation through the competitive peer-review process. For each bridging project undertaken as part of the collaborative project, include a combined summary for the specific aims, background and significance, preliminary studies/progress, and research design and methods. Also include, as applicable, the following sections, which do not count against the page limitations for the section or the overall page limit: Abstract (one paragraph), Human Subjects Research (also see special requirements in the Federal citations below), Vertebrate Animals, and Literature Cited. Pilot Projects (Optional ten-page limit for each) Pilot projects will support the work of investigators not already supported in the area of the collaborative project who have unique skills or expertise to add to the collaborative project effort. For all proposed projects, the underlying rationale and potential impact of the studies should be specifically addressed. How the pilot project will add new elements essential to achieving the goals of the collaborative project must be described. It is necessary to justify well the use of a pilot project taking into account that the collaborative project is entering its final period of support. Projects must be described in sufficient detail to permit evaluation through the peer-review process. For each pilot project undertaken as part of the collaborative project, include the following sections: Abstract (one paragraph), Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods. As applicable, include sections on Human Subjects Research (also see special requirements in the Federal citations below), Vertebrate Animals, and Literature Cited; these sections do not count against the page limitations for the section or the overall page limit. There is a maximum of three pilot projects allowed per large-scale collaborative project. Summary of Page Limits o Combined length of the project summary, progress report, administrative management plan, the project management plan, and plan for termination of funding 50 pages o Plan for handling intellectual property and sharing research resources 3 pages o Administrative core 5 pages o Information dissemination and data coordinating core 5 pages o Bioinformatics core (optional) 15 pages o Scientific cores (optional) 10 pages each o Bridging projects (optional) 5 pages each o Pilot projects (optional) 10 pages each o Combined units (optional) pages equal to combined total for individual elements o Overall limit for the Research Plan 180 pages See also the SPECIAL REQUIREMENTS section above for additional application guidance and instructions. INSTITUTIONAL COMMITMENTS: Letters, signed by authorized business officials of each of the participating investigators' institutions committing support to the large-scale collaborative project, must be included. Applicants that include consortium arrangements should refer to the NIH Grants Policy Statement appendix on consortium arrangements at http://grants.nih.gov/grants/policy/nihgps/part_iii_5.htm#Consortium. APPENDICES: Appendices are allowed for the applications, but they should follow the rules for appendices in the PHS 398 instructions. 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: http://grants.nih.gov/grants/funding/phs398/labels.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 and all copies of the appendix material must be sent to: Helen R. Sunshine, Ph.D. Office of Scientific Review National Institute of General Medical Sciences Building 45, Room Number 3An.12, MSC 6200 Bethesda, MD 20892-6200 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 8 weeks. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIGMS. Incomplete or non-responsive applications will not be reviewed. 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 NIGMS in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Receive a second level review by the National General Medical Sciences Advisory Council REVIEW CRITERIA FOR THE OVERALL PROJECT The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. The scientific review group will address and consider each of the following criteria in assigning the application’s overall score, weighting them as appropriate for each application. SIGNIFICANCE: Does this large-scale collaborative project address a complex biological problem of overarching significance to biomedical science that would be difficult to address by separate grants? Has progress been achieved that has moved its field of research forward? If the aims of the renewal application are achieved, will the field of biomedical science be advanced to a new level at the end of the next period of support? Will these studies affect, in a meaningful and important way, the concepts or methods that drive this field? Is there a commitment to maximize the impact of the collaborative project through the sharing of research resources generated by the large-scale project? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the scientific aims of the collaborative project? Do the plans for future studies build logically on the progress made to date? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the project management plan adequate? Is the administrative framework appropriate? Are the requested components, such as core facilities, critical to achieving the scientific goals of the collaborative project and are they cost effective? Do milestones articulate key indicators set for appropriate times that will demonstrate significant forward progress for the collaborative project? Are the plans to monitor and evaluate progress of the collaborative project adequate? Will the research resources generated by the large scale project be shared with the larger community? Will the group take the views of the scientific community impacted by the large-scale collaborative project into consideration? INNOVATION: Are the large-scale collaborative project's structure and goals novel? Has the work to date been characterized by innovation? Are the proposed aims original and innovative? Will the collaborative project challenge existing paradigms or develop new methodologies or technologies? Will the collaborative project attack a problem in a significantly new way? Will there be value added over individual grants? INVESTIGATORS: Is the PI’s major research activity within the research area of the collaborative project? Has the PI proven to be well suited for the scientific and administrative leadership required to carry out this work? Is the level of effort proposed for the PI and the members of the steering committee appropriate? Is the work proposed appropriate to the experience level of the collaborative project's research and technical staff? Are the participating investigators well chosen for their roles in the collaborative project? Are the research grants of the participating investigators within the area of the collaborative project? Have the investigators functioned effectively as a team? Is the plan to add and delete participating investigators to and from the collaborative project satisfactory? ENVIRONMENT: Do the scientific environments in which the work will be done contribute to the probability of success? Are support personnel and resources in place to advance the work? Will the proposed collaborative project take advantage of unique features of the scientific environments of the component projects? Is the level of institutional support adequate? Is access to the core facilities appropriate? ADDITIONAL REVIEW CRITERIA FOR THE OVERALL PROJECT: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: o Demonstrated and planned commitment to the project by the PI and the members of the steering committee. o Commitment of the host and participating institutions to supporting the large-scale collaborative project, e.g., this would be reflected in efforts to work out ahead of time potential intellectual property issues and to remove any institutional barriers to the establishment and healthy maintenance of the collaborative project. o Commitment and record of the leadership to the sharing of research resources (including data and information, materials such as cell lines and mutant animals, and novel reagents and techniques) generated by the large-scale project with the broader scientific community. O Adequacy of the plans to deal with the intellectual property issues for the collaborative project. o Quality and accessibility of websites and databases available to the broader scientific community. o Adequacy of plans for the termination of the large-scale collaborative project award or continuation with other support at the end of the final period of support. REVIEW CRITERIA FOR THE CORE RESOURCES Consideration of the technical merit of the core units will include: (1) Facilities within the core compared to the state of the art. The contributions of the cores to fulfilling the goals of collaborative project. (2) The extent to which core units promote greater collaboration and cohesiveness among the participating investigators. (3) Qualifications, experience, and commitment to the large-scale collaborative project mission of the investigators responsible for the core resources and their abilities to devote the required time and effort to the program. REVIEW CRITERIA FOR BRIDGING PROJECTS AND PILOT PROJECTS Reviewers will be asked to discuss the following aspects of each bridging and pilot project. SIGNIFICANCE: Does this study address an important problem? For continuing bridging projects, has the progress to date added significantly to the field and served to increase the cohesiveness of the large-scale project? If the aims of the application are achieved, how will scientific knowledge be advanced? Will the proposed studies contribute to achieving the goals of the collaborative project? Will/does the bridging project tie or enhance the independent work of the participating investigator to the collaborative project, or will/does the pilot project add an essential missing aspect to the collaborative project? APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? For continuing bridging projects, has the project evolved in a logical and compelling fashion? Does the applicant acknowledge potential problem areas and consider alternative tactics? Is the proposed work appropriate for support by the large-scale collaborative project or would it be more appropriate for support by a regular research grant? INNOVATION: Does the project employ novel concepts, approaches, or methods? For continuing bridging projects, have innovative results been achieved to date? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? INVESTIGATOR(S): 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)? For continuing bridging projects, has the Principal Investigator proved to be an effective contributor to the overall project? ENVIRONMENT: Does the scientific environment in which the work will/has been 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 CONSIDERATIONS FOR THE OVERALL PROJECT AND ALL COMPONENTS PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below.) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations, below.) 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. BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Application Receipt Date: October 19, 2004/October 19, 2005/ October 19, 2007 Peer Review Date: February/March 2005/2006/2008 Advisory Council Date: May 2005/2006/2008 Award Date: September 2005/2006/2008 AWARD CRITERIA Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o adequacy of plans for handling of intellectual property and sharing of research resources o impact on the broader scientific community o adequacy of plans for termination of NIGMS support o program priorities o program balance o availability of funds REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose-finding studies (phase I); efficacy studies (phase II); efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub- populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH- defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp 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, in the project description and elsewhere in the application as appropriate, 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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 http://grants.nih.gov/grants/policy/policy.htm. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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