EXPIRED
DEVELOPING AND IMPROVING INSTITUTIONAL ANIMAL RESOURCES RELEASE DATE: March 18, 2003 PA NUMBER: PAR-03-077 (Reissued as PAR-07-342) EXPIRATION DATE: June 1, 2006, unless reissued National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER: 93.389 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Design Schedule Requirements o Required Federal Citations PURPOSE OF THIS PA The National Center for Research Resources (NCRR) encourages the submission of individual animal resource improvement grant applications from biomedical research institutions. The major objective of this program is to upgrade animal facilities to support the conduct of Public Health Service (PHS) supported biomedical and behavioral research. A related objective is to assist institutions in complying with the USDA Animal Welfare Act and DHHS policies related to the care and use of laboratory animals. Support is limited to alterations and renovations (A&R) to improve laboratory animal facilities, and the purchase of major equipment items for animal resources, diagnostic laboratories, transgenic animal resources, or similar associated activities. This program announcement (PA) replaces PAR-00-124. RESEARCH OBJECTIVES Animal resource improvement grants are awarded to assist biomedical research institutions in upgrading animal facilities and developing administratively centralized and uniformly effective programs of research animal care in support of PHS-funded research. Another major objective is to assist institutions in complying, and maintaining compliance, with provisions of the USDA Animal Welfare Act and DHHS policies related to the care and use of laboratory animals. MECHANISM OF SUPPORT This PA will use the NIH G20 award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. The mechanism available for the support of these improvement projects is the Grant for Repair, Renovation, and Modernization of Existing Research Facilities. The total budget request for the improvement grant application and award is limited to $700,000 (direct costs). The $700,000 request may be used (a) entirely for movable equipment (e.g., cages, static racks); (b) for renovation, repair or modernizing the facility and for fixed equipment; and (c) in any combination of option (a) and (b) to reach the $700,000 maximum request limit of the award. Facilities and administrative costs are not allowed. The matching requirement for all applicants has been eliminated. This is a change from past announcements. Since the nature and scope of the projects proposed in response to this PA might vary, it is anticipated that the size of an award will vary also. ELIGIBLE INSTITUTIONS o Non-profit organizations o Domestic 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 Foreign institutions are not eligible to apply. Any domestic public or private institution, organization, or association is eligible to apply for this grant if the institution has one or more research projects currently supported by the PHS that involve the use of laboratory animals. Institutions and commercial firms providing only services or products and without a clearly defined animal related research component are not eligible to apply. Also, this program will not support requests for equipment used for teaching purposes and for housing non-research animals. Applications from other Federal agencies or institutions (e.g., Department of Veterans Affairs) are limited to requests for equipment only. Institutions may submit one application for developing and improving institutional animal resources (G20) in the same Federal fiscal year. An institution may submit two applications from two different "stand alone" components that are uniquely identified subordinate organizational elements of the institution (for example, a medical school and a dental school within a university). If this is done, documentation from an appropriate institutional official stating that the applications are part of a coordinated, campus-wide plan to improve the animal facilities, must be provided as part of the applications. However, the applicant institution is strongly encouraged to develop a single application for a campus-wide program with a single, centralized animal care program whenever possible or feasible. Applications to this PA does not prohibit the submission of an application to expand, remodel, renovate, or alter existing animal facilities or construct new animal facilities through the Extramural Research Facilities Improvement Program Projects (C06). INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The Principal Investigator must be an established biomedical or behavioral research scientist or a board certified Doctor of Veterinary Medicine. He/she should be supervising an active research laboratory that is supported by relevant, peer-reviewed, research grants (NIH, NSF or other peer-reviewed research awards). Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS ALLOWABLE COSTS: Items that may be requested under this grant mechanism include: o A&R to improve existing laboratory animal facilities, and allowable fees associated with the A&R project. o Major resource fixed equipment related to the improvement project, such as animal cage systems and cage washers. o Equipment items, or an aggregate of identical equipment items, that have a total cost of $5,000 (or lower, depending on the institution's definition for equipment). Items that are part of a system and require the purchase of small component parts (e.g., a rack and cages or microisolator units) may be requested and priced as a single item. A description of the individual components of such systems must be provided. o General-purpose equipment items for centralized surgeries, diagnostic laboratories, transgenic animal facilities, and other similar associated activities when they are an integral part of the animal facility and available to all investigators. o Basic equipment such as microscopes necessary for operation of the facility. o Environmental monitoring systems. However, if such a system has multiple uses (e.g., the monitoring of research data), only those costs related to monitoring or providing for animal care (e.g., environmental monitoring or security) are allowable. Improvement grants are not intended to provide support for: o General operational support for the resource (e.g., funding for personnel or consumable supplies for routine animal care). o Specialized research equipment or facilities for use by only a few investigators. o New construction, including the completion of shell space. o Equipment intended for teaching or non-research purposes. o Office and research equipment, computers or data processing items. DESIGN SCHEDULE REQUIREMENTS: The NIH extramural Developing and Improving Institutional Animal Resources grant (G20) requires all funds to be obligated within five years. Following the receipt of a Notice of Grant award, the institution must sign and return the Terms and Conditions of the award to the Office of Grants Management, NCRR, in order to begin the design phase of the award. Because the award has a five-year time limit for completion of the construction project, the grantee is required to begin the design phase immediately following the return of the signed Terms and Conditions. The grantee must development the design document within the first two years of the award (completion of the designs in less than two years is acceptable). Grantees should allow four to six weeks for the NIH review of each design submission. All submitted design documents must be approved by the NCRR/NIH and the grantees must adhere to the following design document approval schedule: o Design document (100% complete): 6 to 24 months The design documents must be completed with the first 24 months of initial award budget period. WHERE TO SEND INQUIRIES Inquiries concerning this PA are encouraged and the opportunity to answer questions from potential applicants is welcomed. Inquiries may fall into three areas: programmatic/technical, peer review, and financial or grants management issues: o Direct inquiries about programmatic issues to: Dr. Willie D. McCullough Division of Research Infrastructure National Center for Research Resources 6705 Rockledge Drive, Room 6132 - MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0766 FAX: (301) 480-3770 Email: [email protected] o Direct inquiries about technical programmatic issues (engineering and architectural) to: Mr. Esmail Torkashvan, P.E. Division of Research Infrastructure National Center for Research Resources 6705 Rockledge Drive, Room 6136 - MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0766 FAX: (301) 480-3770 Email: [email protected] o Direct inquiries about peer review issues to: Dr. D.G. Patel Office of Review National Center for Research Resources 6705 Rockledge Drive, Room 6018 - MSC 7965 Bethesda, MD 20892-7965 Bethesda, MD 20817 (express/courier) Telephone: (301) 435-0824 Email: [email protected] o Direct inquiries about financial or grants management matters to: Mr. Paul Karadbil Office of Grants Management National Center for Research Resources 6705 Rockledge Drive, Room 6086, MSC 7965 Bethesda, MD 20892-7965 Telephone: (301) 435-0844 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: [email protected]. Prospective applicants are encouraged to review the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2001/part_iib_2.htm) sections dealing with alterations and renovations and equipment prior to completing the PHS 398 form. Applications must follow the instructions provided in the form PHS 398 kit, except for the following: Form Page 1: Item 2 - Check the box marked "YES" and type in the number and title of this program announcement. Item 5 - Check the box marked "No"; Item 5a and 5b are not applicable. Item 6 - The initial budget is for one year. Form Page 2: Personnel - Only key personnel, investigators who will use the proposed facilities, the principal investigator and the program director should be listed here although salary support may not be requested. This must include the chief or consulting veterinarian. Justify the budget and include vendor quotes if available. Biographical Sketch Page - Provide a biographical sketch (4-pages including research support) for key personnel who will use the proposed facilities, the principal investigator and the program director. Specific Instructions - Research Plan Follow the PHS 398 instructions for this section of the application including appropriate font size and margin requirements. Revised applications must include an introduction addressing criticisms and must highlight changes in the application as described in the instructions for PHS 398. The Research Plan section of the application (Items A-D) must strictly adhere to a limit of 25 pages. The outline suggested below should be followed in describing the program. All information critical to the review must be in the Research Plan, not in an appendix. Limit appendices to only additional information relevant to the information outlined in the application for the construction of the proposed facility for which NCRR-support is sought. Do not submit general institutional reports and strategic plans not directly related to the facility described in the application. Examples of information to be included in the appendices, if applicable, are: o Environmental Analysis Form o Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) Report o Institutional Animal Care and Use Committee (IACUC) Report o Equipment specifications o Occupational Health Program A. Specific Aims - Clearly present the aims of the animal resource improvement project and relate them to the short- and long-term goals of the institution's animal resource program, and the research needs of the institution. B. Background and Significance - This section should address the overall animal care and use program and the need for improvements to meet current and future laboratory animal needs for biomedical research. Background Provide an overall description of the institution's animal care and use program. Give relevant background information and describe the current status of the institution's animal resource facilities and program as they relate to biomedical research and research training. Describe the institution's overall involvement in animal-related research. This section should include a description of the following aspects of the animal resource: 1. Administrative arrangements and structure of the animal resource The lines of authority and responsibility for administering the institution's animal care and use program should be clearly presented. The role and composition of the Institutional Animal Care and Use Committee (IACUC) and how compliance with relevant laws, policies, and guidelines is achieved should be included. 2. Animal care procedures and the animal health program - This section should describe housing, caging, feeding, record keeping, sanitation, and other animal care practices; animal health program which includes clinical services, laboratory support, preventive medicine programs, and any relevant specialized procedures; veterinary oversight; vendor surveillance; conditioning programs; colony and environmental monitoring; and diagnostic capabilities in anatomic pathology, clinical chemistry, hematology, and microbiology. Data should be provided to characterize the extent of these activities, such as numbers of laboratory procedures for monitoring animal health, veterinary inspections for animal health, etc. If specialized equipment items are requested, the husbandry program to utilize this equipment should be outlined. 3. Staffing - Outline the total staff and organization of the animal resource, both currently in place and as planned following the requested improvements. Briefly describe the qualifications of the animal care staff and the training opportunities available to them. 4. Animal Program Data - Indicate the number of animals (by species) used or produced per year and the average daily census (by species) for each facility. Provide a brief description of all on-campus and off-campus animal facilities, including sites where experimental surgery is performed. Indicate who manages each facility. Indicate whether the institution is accredited by the American Association for Accreditation of Laboratory Animal Care (AAALAC). If equipment is requested for surgical or diagnostic facilities, the caseload, species, types and numbers of surgeries or diagnostic tests must be documented. 5. Animal Program Funding - Provide, for the most recently completed Federal fiscal year information on: (1) Investigators currently using the facility, including types of animals involved and level of usage; (2) the institution's total number and total direct costs of research projects using laboratory animals, indicating separately the number and costs of those funded from PHS and non-PHS sources; (3) for facilities for which improvement support is requested, list by facility name the number of research projects and total direct costs of the projects relevant to each. List all current financial support for the animal resource, including sources and amounts (e.g., recharge, core funding from the institution, etc.) and the annual operating budget (listed by major categories). Provide a copy of per diem and service charge schedules and indicate their method of determination (this information may be included in an Appendix). 6. Previous and Future Improvements - Expenditures for capital improvements (facilities and equipment) during the past five years and future plans for meeting such needs should be described. Any previous support for improvement of the institution's animal facilities from the NCRR, NIH should be noted. The use of this support and its impact on the animal care program should be briefly described. 7. Program Needs - List deficiencies in the animal care program that have been cited by the AAALAC, the IACUC facility review reports, and the institution's PHS Animal Welfare Assurance Statement. Any problems in meeting the provisions of the Animal Welfare Act should also be addressed. 8. Funding Provide a table listing current and pending research grants (from the NIH and other sources) that will be affected by this project. Give details such as the title, principal investigator, grant number, source and annual amount of funding, and start and end dates. List only those projects, which will be active from the start date on the application face page. Significance Describe the significance of the proposed resource improvement project to the institution's overall biomedical research programs, as well as to specific research projects that will be affected. If appropriate, the application should demonstrate both the need for the requested items and a sound plan for obtaining or maintaining the entire animal resource at required standards. C. Progress Report/Preliminary Studies - Not applicable. D. Research Design and Methods Clearly show how the proposed improvements will expand, improve or maintain existing research and research support activities. Brief descriptions of major research projects using the resource should be provided including source, time period, and amount of funding and level of animal usage. Future scientific needs to be addressed as part of the improvement should also be described. It is important to describe how the requested improvements will correct the deficiencies and problems described in the Background section. Demonstrate how the proposed facility improvement program fits into the institution's overall plan to meet or maintain PHS standards for animal care and use. If the project is part of an overall (larger) facility improvement plan, the application should describe the larger plan and how the project fits into that plan. Describe and provide detailed justifications for the requested equipment items. The manufacturer, model number, size, capacity, or design criteria, total unit cost and facility where it will be used should be included. Requests for surgical equipment must be justified by listing the number of investigators and PHS grant support received (can be provided in tabular form), the caseload, and the types of surgical procedures performed. Failure to adequately justify each requested item will likely result in its deletion from the recommended budget. For any proposed A&R, a narrative summary (as outlined below), line drawings, and cost estimates must be provided. The following sample format is suggested: Narrative Summary (1) Relate the proposed renovations to the projected animal populations (by species) and research projects that will use the facility. (2) List the functional components, including the size (dimensions) and square footage of each component (room, alcove, cubicle) that will be directly affected by the renovation project. (3) List engineering criteria applicable to each component (mechanical, electrical, and utilities). Include information such as the number of air changes per hour, electrical power, light levels, hot and cold water, steam. (4) List appropriate architectural criteria (such as width of corridors and doors, surface finishes). (5) List and justify all fixed equipment items requested for the renovated area. (6) List and justify all movable equipment items requested for the renovated area. Line Drawings (1) Submit line drawings on 8-1/2" x 11" paper only. (DO NOT SUBMIT BLUEPRINTS) These drawings will not be counted against the 25-page limit. All floor plans must be legible, with the scale clearly indicated. (2) The line drawings of the proposed renovation must be at a scale adequate to explain the project. The drawings should indicate size (dimensions), function, and net and gross square feet of space for each room. The total net and gross square feet of space to be renovated should also be given. (3) The plan should indicate the location of the proposed renovation area in the building. (4) Include the as-built drawings of the proposed renovation area and indicate any areas which will be demolished. (5) Changes or additions to existing mechanical and electrical systems should be clearly described in notes made directly on the plan or attached to the plan. (6) Indicate the type(s) of new finishes to be applied to room surfaces. Cost Estimates Detailed cost estimates must be included. Provide vendor quotes when available. APPLICATION RECEIPT DATES: June 1, annually 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 (with all copies of appendix materials) must be sent under separate cover to: Dr. D.G. Patel Office of Review National Center for Research Resources 6705 Rockledge Drive, Room 6018 - MSC 7965 Bethesda, MD 20892-7965 Bethesda, MD 20817 (express/courier) Telephone: (301) 435-0824 Email: [email protected] APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA that is essentially the same as one currently pending initial review unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of a substantial revision of an application already reviewed, but such application must include an Introduction addressing the previous critique. 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: Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Receive a written critique o Receive a second level review by the National Advisory Research Resources Council REVIEW CRITERIA Applications will be reviewed for completeness by the Center for Scientific Review as well as the Office of Review, NCRR. Those applications judged to be incomplete or ineligible will be returned to the applicant. Applications that are complete will be reviewed for scientific and technical merit by the Scientific and Technical Review Board on biomedical and Behavioral Research Facilities established for this purpose by the NCRR. As part of the initial merit review, all applications will receive a written critique and receive a second level review by the National Advisory Research Resources Council. Factors considered in the appraisal of an animal resource improvement project include: A. The Improvement Request 1. Research to be supported - The overall scope of the ongoing PHS-supported biomedical and behavioral research involving laboratory animals, which will be affected by the proposed improvements, will be considered. The specific impact of the proposed construction on existing and future PHS-supported biomedical and behavioral research, research training and/or research support activities related to only the NCRR-supported construction project described in the application for the proposed facility. In addition, the resulting expanded or proposed future biomedical and behavioral research activities will be considered. 2. Need - The application should show how the grant support will meet current and future laboratory animal research needs, particularly for smaller or developing institutions, and how this will help the institution meet or maintain standards of the Animal Welfare Act and PHS policies concerning the care and use of laboratory animals. 3. Design Considerations - The proposed project will be judged for technical soundness, appropriateness and suitability of the proposed renovation project for addressing current and future needs of the institution. 4. Budget - the budget will be evaluated in relationship to the application's responsiveness to these guidelines, justification provided for each of the requested items, cost effectiveness, and the institution's perceived commitment to the animal care program. B. The Animal Care Program The scope of the animal care and use program to be enhanced by this facility improvement request should be carefully defined. For the purpose of this application, the animal care program should cover the entire applicant institution. 1. Animal Care - The quality of the animal husbandry program at the applicant institution will be assessed. The extent to which the project will enhance the welfare of animals maintained in the facility will be evaluated, including advances in the humane treatment of the animals due to husbandry changes allowed by the improvements. 2. Personnel - The technical and professional staff will be evaluated. The institution should have a sufficient number of professional staff with appropriate qualifications and experience to operate the animal resource in a competent manner. The facility should also have qualified non-professional staff and supporting services. 3. Administrative Arrangements - An evaluation will be made of the administrative arrangements for routine management of the animal resource. The institutional plan to assure a comprehensive and acceptable animal care and use program will be evaluated. The institution should have a record of commitment and a sound plan for financial support of the resource, through a recharge system, per diem charges, institutional support, etc. 4. Resources and environment - The suitability of the institutional setting for achieving the goals of the program will be considered. This will include an appraisal of the academic environment and the support for the animal resource by the administration and faculty. AWARD CRITERIA Applications will compete with all others in the G20 category for available funds. An institution must have current PHS funding for research involving laboratory animals to be eligible for an award. The following will also be considered when making funding decisions: o Merit of the proposed project as determined by peer review. o Availability of funds. o Facility requirements of the institution. Evidence of continued PHS research funding will be verified prior to award. Award Conditions Following the award, funds for A&R will not be released until final architectural drawings, specifications, and updated cost estimates are approved by NCRR. The grantee will begin a process of design approval with the Division of Engineering Services (DES) immediately upon receipt of the Notice of Grant Award. No requests to initiate the bidding process for alterations or renovations will be entertained prior to receipt of the grant award from NIH and subsequent approval of working drawings and specifications by NIH staff. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed five years and no indirect costs or continuation costs will be awarded. The initial budget period is for one year. All funds must be obligated within 5 years from the date of award. 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 http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this PA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93-389. Awards will be made under the authority of the Public Health Service Act, Title III, Section 301 (Public Law 78.410, as amended; 42 USC 241) and administered under NIH grant policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74 or 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 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 routing 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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