RESEARCH COLLABORATIONS TO PROVIDE 900 MHZ NMR SPECTROSCOPY Release Date: June 20, 2001 RFA: RFA-GM-01-005 National Institute of General Medical Sciences (http://www.nigms.nih.gov) Letter of Intent Receipt Date: October 15, 2001 Application Receipt Date: November 15, 2001 PURPOSE The National Institute of General Medical Sciences (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. In addition, it is expected that by working together these groups of investigators will create new methods that will further expand the power of NMR spectroscopy to describe important biological molecules and events. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), Research Collaborations To Provide 900 MHZ NMR Spectroscopy, 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/. ELIGIBILITY REQUIREMENTS The NMR spectroscopy resources funded via this initiative are intended to facilitate research in scientific areas of interest to NIGMS. Potential applicants should visit the NIGMS web site at http://www.nigms.nih.gov for detailed information. Consistent with NIH policy for applications that will exceed $500,000 in direct costs in one year, applications submitted under this RFA will not be accepted without the prior approval of NIGMS. Only Principal Investigators (PIs) of NIGMS-funded R01, R37, or P01 grants with one or more years of support remaining at the time of award can serve as the PI of an NIGMS-funded NMR spectroscopy resource. A majority of the collaborating investigators must also have funding from the NIGMS. Other collaborators must have externally peer-reviewed research funding. Their projects should be consistent with the NIGMS mission. Scientific areas supported by NIGMS are described on our web site at http://www.nigms.nih.gov/about_nigms/overview.html. Applications may be submitted by domestic, non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Applications from foreign institutions and from for-profit organizations will not be accepted. 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. 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 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. The total project period proposed in an application submitted in response to this RFA may not exceed five years. Future unsolicited competing continuation applications for operational expenses will compete with all investigator- initiated applications and be reviewed according to the customary peer review procedures. The anticipated award date is July 1, 2002. FUNDS AVAILABLE NIGMS intends to commit approximately $11 million dollars total costs in FY 2002 and $0.6 million total cost per annum in FY 2003-2006 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. 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 structures and behavior of new categories of biomolecules, 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 folding, protein-protein binding, and binding-induced conformational changes, that are key to normal biological function and regulation and also intimately 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 announcement is to provide NMR spectrometers of 21T or greater to collaborative groups of NIGMS-funded investigators who have challenging biological problems that require the special advantages of ultra- high field NMR spectroscopy. In addition, it is expected 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. It is not required that the projects of collaborating investigators be closely integrated according to a research topic. Rather, it is expected that the collaborators will share a common vision of how NMR spectroscopy at ultra-high field can be applied and advanced to provide a qualitative improvement in our ability to understand critical biomolecular events. SPECIAL REQUIREMENTS Determination of three-dimensional structures of biomacromolecules 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, https://grants.nih.gov/grants/guide/notice-files/not99-010.html, regardless of the source of funding for the project. This policy requires free release of atomic coordinates and other necessary data immediately upon publication. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 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 biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are 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 research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a complete copy of the updated Guidelines are available at https://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to 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) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. 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. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at: https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA (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. LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes a descriptive title of the proposed research resource, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of this RFA. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows Center for Scientific Review (CSR) staff to estimate the potential review workload and plan the review. The letter of intent is to be sent to the program official named at the end of this RFA by the letter of intent receipt date listed in the heading. APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. 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 will maximally benefit from use of the ultra-high field spectrometer and should provide an organizational plan for selecting, 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. 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. To facilitate the review process, potential members of external advisory or similar committees 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. The RFA label available in the PHS 398 (rev. 4/98) 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 sample RFA label available at https://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to allow for this change. Please note this is in pdf format. 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) 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. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIGMS. Incomplete and/or non-responsive 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 receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National General Medical Sciences Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Do the studies proposed address important problems? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Will the added information provided by the 900 MHz spectrometer make a fundamental difference in our understanding of the specific target system or of broader categories of important biological target molecules? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? 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? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Do the studies employ novel approaches or methods? Is the technical development likely to provide fundamentally new approaches to macromolecular characterization? (4) Investigator: Is the investigator 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 the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there adequate evidence of institutional support? Is the physical environment adequate to support the proposed activities? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. o The adequacy of the proposed plan to share data, if appropriate. Additional 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 will be used in selecting future projects. Schedule Letter of Intent Receipt Date: October 15, 2001 Application Receipt Date: November 15, 2001 Peer Review Date: February-March, 2002 Council Review: May, 2002 Earliest Anticipated Start Date: July, 2002 AWARD CRITERIA Award 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 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or answer questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Janna P. Wehrle, Ph.D. Division of Cell Biology and Biophysics National Institute of General Medical Sciences Natcher Building, Room 2AS.19K MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5950 FAX: 301-480-2004 Email: wehrlej@nigms.nih.gov Direct inquiries regarding review issues to: John Bowers, Ph.D. Center for Scientific Review 6701 Rockledge Drive, Rm. 4168 Bethesda, MD 20892-7710 Telephone: (301)435-1725 Email: bowersj@csr.nih.gov Direct inquiries regarding fiscal matters to: Joe Ellis Grants Management Officer National Institute of General Medical Sciences Natcher Building, Room 2AN.32 MSC 6200 Bethesda, MD 20892-6200 Telephone: (301) 594-5510 FAX: (301)480-1969 Email: ellisj@nigms.nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.821. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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