RESEARCH COLLABORATIONS TO PROVIDE 900 MHZ NMR SPECTROSCOPY RELEASE DATE: June 25, 2002 RFA: GM-03-001 National Institute of General Medical Sciences (NIGMS) ( LETTER OF INTENT RECEIPT DATE: October 15, 2002 APPLICATION RECEIPT DATE: November 15, 2002 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 Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The purpose of this RFA is to re-announce the National Institute of General Medical Sciences (NIGMS) program to create "Research Collaborations to Provide 900 MHz NMR Spectroscopy," last issued as GM-01-005 in July 2001. The NIGMS believes that nuclear magnetic resonance (NMR) spectrometers operating at field strengths of 900 MHz (21.1T) or higher have the potential to dramatically improve our understanding of the structure and dynamics of proteins, nucleic acids, and other biological macromolecules. The purpose of this program is to provide shared access to ultra-high field strength NMR spectrometers for groups of NIGMS-funded investigators studying challenging biological problems that can uniquely benefit from the use of ultra- high field NMR spectroscopy. RESEARCH OBJECTIVES Background and Rationale Recent breakthroughs in the design and execution of NMR experiments and in the analysis and interpretation of NMR data have created the possibility of determining the solution structure and behavior of new categories of biological macromolecules, including larger proteins, macromolecular complexes, glycoproteins and glycolipids. Moreover, NMR spectroscopic methods are now being developed that can describe--in atomic detail--dynamic processes such as protein and RNA folding, protein-protein and protein-nucleic acid complex formation, and binding-induced conformational change. These processes are key to normal biological function and regulation and are critically involved in disease processes and drug response. NMR experiments capable of attacking these more challenging targets have a particular need for higher magnetic field strength. Access to next-generation NMR spectrometers for NIGMS-funded researchers will dramatically advance our understanding of a wide range of vital physiological and pathological phenomena. Objectives The purpose of this program is to provide ultra-high field NMR spectrometers to groups of NIGMS-funded investigators so they can solve significant and challenging biological problems. In addition, NIGMS expects that these collaborations will lead to the design and implementation of novel NMR experiments capable of providing insights beyond those that can be predicted from current knowledge. The projects of the collaborating investigators should be of great biomedical importance, and have pressing need for the new spectrometer, but they need not be closely integrated according to research topic. Rather, the collaborators should identify a common vision of how NMR spectroscopy at ultra-high field can best be applied and advanced to provide a qualitative improvement in our ability to observe and understand critical biomolecular events. MECHANISM OF SUPPORT This RFA uses the National Institutes of Health (NIH) P41 Biotechnology Resource Grant mechanism, which is used by the NIGMS to make extraordinary research instrumentation available to organized groups of our investigators for the solution of significant and challenging problems in biomedical research. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications for operational expenses will compete with all investigator-initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is July 1, 2003. An applicant may request no more than $5 million in direct costs in the first year for the purchase of an NMR spectrometer with a field strength of 21T or greater. In addition, up to $200,000 in direct costs per year for no more than five years may be requested for continuing support of the spectrometer and operation of the resource. The budget might include items such as: o Salaries for personnel responsible for technical development, spectrometer installation, maintenance, upgrade, and programming, or assistance and training of collaborators. o Salaries for individuals, including the PI, responsible for the organization and operation of the resource. o Spectrometer hardware and software. o Supplies such as cryogens, sample holders, and electronic storage media. o Establishment of computer systems to allow remote operation and facilitate collaboration. Funds provided via this program are not intended to support the individual research projects which use the spectrometers. These should be supported by independent peer-reviewed funding to the collaborators. Funds will not be provided for the selection, construction, or renovation of a site for the spectrometer. Responsibility for the planning, direction, and execution of the proposed project, including appropriate siting, will be solely that of the applicant. FUNDS AVAILABLE NIGMS intends to commit approximately $11 million dollars total costs in FY 2003 and $0.6 million total cost per annum in FY 2004-2007 to fund one to three new grants in response to this RFA. Because the nature and scope of the requests may vary, the size of awards may 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 a sufficient number of meritorious applications. At this time, it is not anticipated that this RFA will be reissued. ELIGIBLE INSTITUTIONS You may submit an application if your institution is domestic and 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 Under this funding mechanism, foreign institutions are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The NMR spectrometers funded via this initiative are intended to facilitate research in scientific areas of interest to NIGMS. Only a Principal Investigator (PI) of an NIGMS-funded R01, R37, or P01 grant with one or more years of support remaining at the time of award can serve as the PI. A majority of the collaborating investigators must also have funding from the NIGMS. Other collaborators must have externally peer-reviewed research funding in areas consistent with the NIGMS mission. Scientific areas supported by NIGMS are described on our web site at SPECIAL REQUIREMENTS Three-dimensional structures of biomacromolecules determined in whole or in part using these spectrometers by any individual, whether a collaborator or other user, will be subject to the NIH rules for deposition and release of structure information via the Protein Data Base and the BioMagResBank,, regardless of the source of funding for the project. This policy requires free release of atomic coordinates and other necessary data immediately upon publication. WHERE TO SEND INQUIRIES Applications submitted under this RFA will not be accepted without the prior approval of NIGMS. Inquiries are strongly encouraged and may fall into three areas: scientific/research, peer review, and financial or grants management issues. o Direct your questions about scientific/research issues to: Janna P. Wehrle, Ph.D. Division of Cell Biology and Biophysics National Institute of General Medical Sciences Building 45, Room 2AS.19K MSC 6200 Bethesda, MD 20892 Telephone: (301) 594-5950 FAX: (301) 480-2004 Email: o Direct your questions about peer review issues to: John Bowers, Ph.D. Center for Scientific Review 6701 Rockledge Drive, Room 4168 Bethesda, MD 20892-7710 Telephone: (301) 435-1725 Email: o Direct your questions about financial or grants management matters to: Joe Ellis Grants Management Officer National Institute of General Medical Sciences Building 45, Room 2AN.32C MSC 6200 Bethesda, MD 20892 Telephone: (301) 594-5510 FAX: (301) 480-1969 Email: LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, and telephone number of the Principal Investigator o Names of other key personnel o Participating institutions o Number and title of this RFA Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows Center for Scientific Review staff to estimate the potential review workload and plan the review. The letter of intent is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Janna P. Wehrle, Ph.D. Division of Cell Biology and Biophysics National Institute of General Medical Sciences Building 45, Room 2AS.19K MSC 6200 Bethesda, MD 20892 Telephone: (301) 594-5950 FAX: (301) 480-2004 Email: 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 in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: SUPPLEMENTAL INSTRUCTIONS The application must document a clear plan for operation of the research facility and for exploitation of the unique capabilities of the 900 MHz spectrometer to advance biomedical science. It should describe a complete plan for selecting and purchasing a spectrometer, including the physical plan for siting, installation, and operation of the spectrometer. The resources and environment available to support both the requested instrument and any necessary on-site research activities should be itemized. Any plans for remote execution of NMR experiments should be described in detail. The application should list the criteria that will be used to identify projects that can maximally benefit from use of the ultra-high field spectrometer and should provide an organizational plan for selecting projects and allocating instrument time. Descriptions of already funded collaborative projects should be brief and should emphasize the novel information that will be provided by the ultra-high field NMR spectrometer, compared with that obtained using conventional instruments. A process for adding and terminating projects should be laid out. Plans for development of novel experiments, hardware, or software should be described in detail. To facilitate the review process, potential members of any external advisory or similar committees proposed should not be approached prior to award, nor identified in the letter of intent or application. The roles and functions of any such committees should be described in concept only. Do not exceed 25 pages for items a-d of the Research Plan. The written application should be complete. It is not anticipated that an applicant interview will be a part of the review process. Appendices may be included, following the instructions for unsolicited applications described in form PHS 398. 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: SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and five signed photocopies, plus five sets of appendix material, 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 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. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and for responsiveness by the NIGMS. Incomplete applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the Center for Scientific Review 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 Advisory General Medical Sciences 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? Will the added information provided by the 900 MHz spectrometer make a fundamental difference in our understanding of the specific target systems or of broader categories of important biological molecules? (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? Are the organizational and decision- making structures well-designed to promote collaboration? Are the technical foundations of novel methods to be developed well-reasoned and sound? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project develop new methodologies or technologies? Is the technical development you propose likely to provide fundamentally new approaches to macromolecular characterization? (4) INVESTIGATOR: Are you appropriately trained and well suited to direct this resource, both scientifically and organizationally? Do the collaborators have the appropriate biological and technical expertise to fully exploit and expand the potential of the instrument? (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 and employ useful collaborative arrangements? Is there adequate evidence of institutional support? Is the physical environment adequate to support the spectrometer and the proposed research activities? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application will also be reviewed with respect to the following: o 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. o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o OTHER REVIEW CRITERIA: The scientific merit of the already funded collaborative projects will not be re-reviewed. Reviewers will assess the extent to which these projects will significantly benefit from the availability of the resource. The collaborative projects proposed in the application will be considered an indication of the criteria and judgment that you will use in selecting future projects. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: October 15, 2002 Application Receipt Date: November 15, 2002 Peer Review Date: February-March, 2003 Council Review: May, 2003 Earliest Anticipated Start Date: July 1, 2003 AWARD CRITERIA Criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities o Adequacy of institutional commitment. REQUIRED FEDERAL CITATIONS PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.821, 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 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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