NCRR HIGH END INSTRUMENTATION PROGRAM RELEASE DATE: May 29, 2003 RFA: RR-03-009 (This RFA has been reissued, see PAR-05-124) National Center for Research Resources (NCRR) ( CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.389 LETTER OF INTENT RECEIPT DATE: August 15, 2003 APPLICATION RECEIPT DATE: September 19, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators 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 In recognition of the need for and advantages of continuing investment in new instrumentation for the advancement of biomedical research, the National Center for Research Resources (NCRR) is reissuing the High End Instrumentation (HEI) Program for the support of research instrumentation. Awards will be made for up to a maximum of $2.0 million in direct costs for a single major item of equipment. Instruments in this category include, but are not limited to, structural and functional imaging systems, macromolecular NMR spectrometers, high-resolution mass spectrometers, electron microscopes, and supercomputers. RESEARCH OBJECTIVES With advances in technological development, biomedical scientists require ever more powerful tools for their research. As new instruments with enhanced performance become available, their importance for research increases along with the costs. Although the Shared Instrumentation Grant Program (SIG) provides a cost-effective mechanism for groups of NIH supported investigators to obtain commercially available equipment costing between $100,000 and $500,000, there is a continuing need for an NIH program that provides expensive, high-end instruments to the broad community of basic and clinical scientists. To meet the demands of the community, the NCRR initiated this HEI program in FY 2002 to support expensive, high-end instruments. Examples of key instruments in this category include but are not limited to: Biomedical Imagers: The boundaries of imaging technology have been extended to acquire functional, biochemical and physiological information in intact biological systems including humans. This has led to an increased demand for multinuclear spectroscopy and functional magnetic resonance and PET imaging instruments. Nuclear Magnetic Resonance Spectrometers: There is a significant demand for increased sensitivity and resolution of high-field NMR spectrometers to determine three-dimensional structures of large proteins and protein complexes in extremely small samples. This need is magnified by the extended run time for data collection at lower fields, which limits access to these instruments. Mass Spectrometers: Instruments that combine electrospray ionization with Fourier transform ion cyclotron resonance (FTICR) mass spectrometry are now available. The FTICR methods provide very high resolution and accurate molecular weight measurement to study large biopolymers and their interactions. Electron Microscopes: The frontier of cell biology now focuses on elucidating the nature and function of cell organelles and the role of complex protein machines. Such studies require intermediate voltage electron microscopes with field emission illumination for high resolution imaging of single molecules. Such microscopes are also needed to perform computer reconstruction at the subnanometer scale for macromolecular assemblies that are too large and complex to study by x-ray crystallography and NMR spectroscopy. Supercomputers: Computational biologists require computers or clusters of computers with high-performance visualization hardware, parallel architectures, and large data storage and transfer capabilities at increased speed. Applications for general use computer networks will not be accepted. Application for synchrotron equipment, with the exception of detectors, will not be accepted. The application should also show a clear need for the instrumentation by projects supported by multiple NIH peer review research grants (including, but not limited to those listed above) and demonstrate that these projects will require at least 75 percent of the total usage of the instrument. Users can be individual researchers, or a group of investigators within the same department or from several departments at the applicant institution. NIH extramural awardees from other institutions may also be included. It is expected that most of the equipment requested in the HEI Program will be of a specialized nature and will require a high level of technical expertise to operate the instrument and conduct experiments. Therefore, for the requested instrument to be used effectively and to avoid abuse of instrumentation, which frequently occurs in an open access environment, the bulk of the research time may have to be reserved for a few investigators. Alternatively, some type of instruments might be accessed by the research community through collaborations with appropriate investigators. Other types of instruments requested may not be as dedicated and will serve a broadly diversified biomedical community. In any case, priority for instrument use should be given to NIH-supported scientists engaged in biomedical/behavioral research. The Principal Investigator must be able to assume administrative and scientific oversight responsibility for the instrument requested. An internal advisory committee must be named to assist the Principal Investigator in administering the grant and overseeing the responsibility for the instrument. The membership of this committee should be broadly based and include members without a conflict of interest who can resolve disputes if they arise. The Principal Investigator and the advisory committee are responsible for the development of guidelines for: o Maximum utilization of the instrument, including time allocation. o A detailed plan for the day-to-day management of the instrument. o A financial plan for the long-term operation and maintenance of the instrument during the post award period. During the post award period, the Principal Investigator will also be responsible for obtaining appropriate no-cost extensions of the project if needed. Ninety days following the end of the project period, a final progress report is required that describes the instrument purchased, and a list of all users and a description of the value of the instrument to the investigators and to the institution as a whole. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) S10 mechanism. The program will assist in the acquisition of major research equipment that is too costly for support through the (SIG) program. Awards will be made for the direct cost of the instrument only. No indirect costs are provided. Matching funds are not required; however, commitment of an appropriate level of institutional support to insure the associated infrastructure is expected (building alterations, or renovations, post- award service contracts and technical personnel). Support for operation and maintenance and trained personnel may also be obtained from the research project grants of the users or supplements to them. The anticipated award date is July 1, 2004. The program will provide 12-month, nonrenewable awards up to a maximum of $2.0 million. Only one major item of equipment can be requested per application. Supplemental applications will not be accepted. Although the focus of the HEI Program is on a new generation of instruments that cost over $1.0 Million, the floor for the program has been set at $750,000. Applications for routine instruments such as mid-field NMR spectrometers, multi-photon microscopes and other applications for requests totaling over $750,000 which are the result of an overestimation of price and/or an excessive number of accessories, will be returned as not being responsive. Identical or very similar applications may not be submitted to the SIG Program and the HEI Program. However, a revised application based on a previously reviewed SIG submission may be submitted to the HEI program. In order to submit a revised application, the investigator must have received the summary statement from the previous review and must address the criticisms raised, in the Introduction. An institution may submit more than one application, but the instruments requested should be substantially different. It is anticipated that only a few grants will be awarded in a given technological area. Generally, if the funds requested do not cover the total cost of the instrument, documentation of the availability of the remainder of the funding, signed by an appropriate institutional official, must be submitted to NCRR prior to issuance of an award. FUNDS AVAILABLE The NCRR intends to commit approximately $22M in FY 2004 to fund approximately 11 to 16 new grants in response to this RFA. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NCRR provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS You may submit an application if your institution has any of the following characteristics: o Non-profit organization o Public or private institutions, such as universities, colleges, and hospitals. o Domestic Foreign institutions are not eligible to apply. Under the general research support authority of Section 301(a)(3) of the Public Health Service Act, High End Instrumentation Grant awards are made to public and non-profit domestic institutions only. These institutions include health professional schools, other academic institutions, hospitals, health departments, and research organizations. Note that Federal institutions, foreign institutions, and for-profit institutions are not eligible to apply. A Federal Institution is defined by the NIH as a Cabinet-level department or independent agency of the executive branch of the Federal Government or any component organization of such a department or agency. To be eligible to apply, three or more NIH funded investigators (Principal Investigators of active P01, R01, U01, R35 or R37 research grants) who will be users of the requested instrument must be identified. Since this program interfaces with other programs, it is strongly urged that applicants contact the staff person in the Division of Biomedical Technology of NCRR before submitting a proposal. INDIVIDUALS ELIGIBLE TO BECOME PRICIPAL INVESTIGATORS Any individual with skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encourage to apply for NIH programs. Although it is not required, it is strongly recommended that the Principal Investigator be a scientist with expertise in the unique technical area. It is not required that the Principal Investigator be an NIH awardee. 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, and financial or grants management issues: o Direct your questions about programmatic or scientific issues to: Marjorie A. Tingle, Ph.D High End Instrumentation Grant Program National Center for Research Resources 1 Democracy Building, Room 958 6701 Democracy Boulevard, MSC 4874 Bethesda, MD 20892-4874 Telephone: (301) 435-0772 FAX: (301) 480-3659 Email: o Direct your questions about financial or grants management matters to: Ms. Jenelle D. Wiggins Office of Grants Management 1 Democracy Building, Room 1038 National Center for Research Resources 6701 Democracy Boulevard, MSC 4874 Bethesda, MD 20892-4874 Telephone: (301) 435-0843 Fax: (301) 480-3777 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 IC 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: Marjorie A. Tingle, Ph.D Program Director High End Instrumentation Grant Program National Center for Research Resources 1 Democracy Building, Room 958 6701 Democracy Boulevard, MSC 4874 Bethesda, MD 20892-4874 Telephone: (301) 435-0772 Fax: (301) 480-3659 Email: SUBMITTING AND 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 Grants Info, Telephone (301) 710-0267. Email: SUPPLEMENTAL INSTRUCTIONS: Follow the PHS 398 instructions with the following special instructions below. Do not use the format for Modular or Just-in-Time applications. Other Support pages are required (see below). This requirement supercedes the instructions for the Other Support pages in the PHS398. 1. Form Page 1 (Face Page) Item 1. Name the type of instrument requested. Item 2. Check the box marked "YES" and enter the number and title of this RFA. Item 4. Not applicable Item 5. Not applicable Item 6. The dates should be 07/01/04 through 06/30/05 Item 7A and 7B, 8A and 8B. Use these blocks to give the total amount requested from NCRR for this instrument or system. The direct costs and total costs for the budget period and project period must be the same. 2. Form Page 2. Complete the abstract as directed. Under "Key Personnel," give the data on the Principal Investigator and other participating investigators. Form page 4. Describe the instrument requested including manufacturer and model number. Use a continuation page(s) as necessary. The model chosen should be justified by comparing its performance with other available instruments where appropriate. Specific features and any accessories should be justified, both in this section and in the description of research projects. Provide a detailed budget breakdown of the main equipment and accessories requested including tax and import duties, if applicable. An itemized quote form a vendor should be included. If a project involves a potential biohazard, funds for accessory containment equipment for the instrument or instrument system may be included in the requested budget. Form page 5. Budget Estimates for All Years. Not applicable; do not complete. Modular Budget Format Page. Not applicable Biographical Sketch Format Page. In addition to the personnel listed on page 2, include a biographical sketch of the person(s) who will be in charge of maintenance and operation of the instrument and a brief statement of the qualifications of the individual(s). Resources Format Page. Not applicable Checklist Form Page. Check all that apply Personal Data Form Page. Complete Other Support Format Page. Provide the requested information for each participating investigator. Personnel Report Format Page. Not applicable Targeted/Planned Enrollment Format Page. Not applicable Enrollment Format Page. Not applicable Research Plan section of the application. (If this is a revised application, note the special instructions on page 15 in the PHS 398 instructions regarding completion of this section of the application). Do not include what would normally be in Items a-d of the Research Plan but provide information relative to the points identified under criteria for review including: Instrument Requested Describe the instrument requested and the significance of the technology to biomedical research. For a new generation instrument present the design concept, rationale and development methods in sufficient detail to allow evaluation of its technical feasibility. Inventory current and related instrumentation at the applicant institution or nearby institutions and describe why they are unavailable or inappropriate for the proposed research. Provide a clear justification why a new instrumentation, including accessories is needed. Include specific documentation on the current usage and downtime of existing instruments and a realistic estimate of the projected usage of the requested instrument. Research Projects Give a brief description of the users' focusing on the benefit of the instrument to the research objectives of each user. Sufficient technical detail (results of preliminary data and/or supplemental information) should be included to evaluate whether the instrument requested is appropriate, would be effectively employed, and would provide advantages over other methods. The need for special features and accessories must be justified. If possible, each user should highlight those publications that demonstrate the users' expertise in using the requested instrumentation. If the number of projects is large and broadly diversified, select out a smaller representative group. Use a table to list the names of the users, brief titles of the projects, the NIH grant numbers and the estimated percentage of use. Make a separate table to indicate the user's needs for the requested accessories. List the page number of each table under "Table of Contents" (Form page 3) after resources. Technical Expertise Describe the technical expertise available at the applicant institution to set up, run and maintain the instrument. Specify how and by whom the instrumentation will be operated and maintained. Are there any collaborations between disciplinary and interdisciplinary scientists for developing the technical aspects of the instrumentation? Outline the roles of the technical staff in training new users and in facilitating the adoption of these state-of-the-art techniques in the users' research programs. Institutional Commitment Explain how the requested instrumentation will contribute to the institution's biomedical research goals. Describe the institutional infrastructure (space, environment and utilities) available to support the instrumentation. Indicate if the institution has any history of making technology available and for keeping instruments in top operating condition. Administration of the Instrument Describe the organizational plan for administering the grant. Include how the instrument will be utilized, how request are made, how time will be allocated to competing research projects and how schedules are posted. How will the results obtained be disseminated broadly to enhance scientific understanding? What are the plans for attracting new users? Include the names and titles of members of local and/or external advisory committees to oversee its use. Describe the role and responsibility of the advisory committee(s) in developing policies and procedures to assure equitable use of the instrument time and their meeting schedules. Financial Administration Provide a financial plan for long-term operation of the instrument. Specify how and by whom the requested instrumentation will be operated and maintained. Pertinent data on user charges, salaries of technical support personnel, maintenance contracts, instrument upgrades, shop charges and other expenses, should be included. Specify the plans for fully funding the instrument. Specify the sources and amounts of cost sharing funds (private, state or institutional funds) and a projection of when they will be available. Give a time frame or prospects for delivery of the instrument. Provide documentation (separate letters signed by appropriate institutional officials) specifically describing the institutional commitment (in dollars) in support of the instrument. 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 NIH: Submit a signed, typewritten original of the application, including the Checklist, and five signed photocopies, in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE ROOM 1040 – MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) Do not send applications for different instruments in the same package. 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. 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. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include the Introduction addressing the previous critique. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCRR. 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 specially convened initial review groups of the CSR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a process in which only those applications deemed to have the highest scientific priority will be discussed, assigned a priority score and receive a second level of review by the National Advisory Research Resources Council (NARRC) REVIEW CRITERIA o Justification of Need: Is the need for the instrument clearly and adequately justified? Is the equipment essential and appropriate? Will the instrument requested have a significant impact on biomedical/behavorial research and contribute to the advancement of human health? o Technical Expertise: Does the institution have the high-level technical expertise and access to the necessary infrastructure to make effective use of the requested equipment? How well qualified are the participating investigators to operate and maintain the instrument, conduct the projects, and evaluate the research results? Are there collaborations in place between disciplinary and interdisciplinary scientists? o Research Projects: Will research with the requested instrument advance the knowledge and understanding of the proposed projects? Will the results be disseminated broadly to enhance scientific and technological understanding? Are there appropriate plans in place for record keeping and bioinformatics? o Institutional Commitment: What is the evidence of institutional commitment to support the instrument? Is institutional infrastructure (technical support, space, environment and utilities) available to support the instrument? Is there an institutional track record for making technology available? o Administration: Is the plan for the management and maintenance of the requested instrument appropriate? Are there plans for maximizing the effectiveness of the investment in instrumentation? Is the membership of the advisory committee broadly based to oversee the use of the instrument for a wide range of biomedical investigators? How will research time be allocated among the projects? o Financial Plan: Is the financial plan for fully funding the purchase and long-term operation and maintenance of the instrument reasonable? Is there appropriate documentation (letters from institutional officials)? advisory committee for oversight of the instrument including sharing arrangements. ADDITIONAL CONSIDERATIONS BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: August 15, 2003 Application Receipt Date: September 19, 2003 Peer Review Date: February/March 2004 Council Review: May 2004 Earliest Anticipated Start Date: September 2004 AWARD CRITERIA In making funding decisions, the NCRR will give consideration to: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities REQUIRED FEDERAL CITIATIONS URLs IN NIH GRANT APPLICATIONS OR APPENDICIES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in all NIH solicitation, Internet address (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 "Health 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 REGUALATIONS: This program is described in the Catalog of Federal Domestic Assistance NO.93.389, Biomedical Technology. Awards will be made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under NIH grants policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency Review. The DHHS strongly encourages all grant and contract 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, daycare, health care or early childhood development services are provided to children. This is consistent with the DHHS mission to protect and advance the physical and mental health of the American people.

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