EXTRAMURAL RESEARCH FACILITIES IMPROVEMENT PROGRAM PROJECTS RELEASE DATE: December 4, 2002 PA NUMBER: PA-03-040 EXPIRATION DATE: August 30, 2003 National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov) 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 Required Federal Citations PURPOSE OF THIS PA The National Center for Research Resources (NCRR) is authorized under Sections 481A and 481B of the Public Health Services Act, as amended by Sections 303 and 304 of Public Law (PL) 106-505, to "make grants or contracts to public and nonprofit private entities to expand, remodel, renovate, or alter existing research or animal facilities or construct new research or animal facilities." The facilities will be used for basic and clinical biomedical and behavioral research and research training. RESEARCH OBJECTIVES The principal objective of this program is to facilitate and enhance the conduct of PHS-supported biomedical and behavioral research by supporting the costs of designing and constructing non-Federal basic and clinical research facilities to meet the biomedical or behavioral research, research training, or research support needs of an institution or a research area at an institution. MECHANISM OF SUPPORT This PA will use the NIH research facilities construction grant mechanism (C06). 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 facilities and administrative (F&A) costs or continuation costs will be awarded. The initial budget period is usually 2 years in length, although extensions may be requested. All funds must be obligated within 5 years from the date of award. The awards will be issued by September 30, 2003. Matching funds ($1 to $1) will be required for the specific project awarded. Matching funds must be non-Federal funds set aside for this project and must be "in hand" at the time the award is made. Under Section 481A, up to 50 percent of the necessary and allowable costs of a project may be awarded: grant funds may not be used for the acquisition of land or for off-site improvements. The maximum award amount will be $4.0 million for all applicants, including Centers of Excellence under section 736 of the PHS Act as amended by Public Law 105-392, and National Primate Research Centers (NPRCs) will be required to provide matching funds in a ratio of 1 to 4 ($1 for each $4 of Federal funds provided) for a maximum award of $4.0 million. A description of the sources of non-Federal funding for the project (both matching funds and funds needed to complete the total project) must be provided with the application. A letter committing matching funds must accompany the application and provide assurance of commitment from an appropriate institutional official authorized to commit funds at the institution. Applications proposing a Federal share of less than $1.0 million or more than the maximum Federal award amount specified above will not be accepted. Because the nature and scope of the activities proposed in response to this PA may vary, it is anticipated that the size of awards will vary also. In unusual and compelling circumstances, the Director, NCRR, may waive some or all of the requirement for non-Federal matching funds [Section 481A (e)(4) of the Public Health Service Act as amended by Public Law 106-505]. For additional information, please refer to URL: http://www.ncrr.nih.gov/resinfra/pawaiver.pdf. 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 Under Section 481A of the PHS Act, domestic, non-Federal, public and private non-profit institutions, organizations, and associations that conduct or support biomedical or behavioral research are eligible to apply, including, for example, allied health professional schools. In response to this PA, an institution, which has currently one or more PHS-supported basic or clinical biomedical or behavioral research projects, may submit two applications to the Research Facilities Improvement Program in the same fiscal year for projects that encompass different scopes and are 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). Applications are encouraged from institutions of emerging excellence, which are defined as recipients of a "Center of Excellence" award in the fiscal year preceding the fiscal year in which an application is submitted in response to this PA. Centers of Excellence (COE) awards are made by the Division of Health Professions Diversity, Bureau of Health Professions, Health Resources and Services Administration, DHHS. A list of the Centers of Excellence, and further information about this program can be found at URL http://bhpr.hrsa.gov/diversity/coe/default.htm. The telephone number for additional information on the COE awards is 301-443-2982. For this PA, the needs of smaller and developing institutions will be given special consideration. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS The Principal Investigator should be a highly placed institutional official, at the level of Dean or equivalent, who has the responsibility for allocation of space for the biomedical or behavioral research and research training. 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: Facility construction that may be supported under this program includes construction of new facilities, additions to existing buildings, completion of uninhabitable "shell" space in new or existing buildings, and major alterations and renovations. The acquisition and installation of fixed equipment such as casework, fume hoods, large autoclaves, or biological safety cabinets are allowed. Support for instrumentation or equipment that usually would be requested as part of a research project grant will not be provided. NOTE: THE USE OF THESE FEDERAL FUNDS TO BUILD "SHELL" SPACE OR ACQUIRE LAND OR MAKE OFF-SITE IMPROVEMENTS IS NOT ALLOWED. 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 regarding programmatic issues, requests for application Standard Form 424, application supplemental instructions, and SPOC comments, if any, 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: mcculloughw@ncrr.nih.gov o Direct inquiries regarding 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: torkashvane@ncrr.nih.gov o Direct your questions 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: dgpatel@ncrr.nih.gov o Direct your questions 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: paulk@ncrr.nih.gov SUBMITTING AN APPLICATION Applicants must use Standard Form 424, "Application for Federal Assistance," modified in accordance with the instructions contained in the document "Application Information and Supplemental Instructions: Extramural Research Facilities Improvement Program Projects." The applicant's full street address is required in column #5 of the Standard Form 424. Application forms and the supplemental instructions required for completing them may be requested from the program official listed under INQUIRIES or downloaded from our web site (http://www.ncrr.nih.gov/resinfra/resfac.pdf). Standard Form 424 fillable forms are available at http://www.whitehouse.gov/omb/grants/index.html - forms. Interested individuals are advised to consult with appropriate officials at their institution before completing the application forms. Appropriate margins and font size are described in the Application Information and Supplemental Instructions. APPLICATION RECEIPT DATE: February 1, 2003 SENDING AN APPLICATION TO THE NIH: The completed signed original and one exact photocopy of the signed application must be submitted to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (express/courier) TELEPHONE: (301) 435-0715 At the time of submission, five additional copies of the application (with appendices, if any) 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: dgpatel@ncrr.nih.gov APPLICATION PROCESSING: Applications must be received by or mailed on or before the receipt dates. 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. o Intergovernmental Review -- Executive Order 12372 Applicants are required to comply with Executive Order (E.O.) 12372 as implemented by 45 CFR Part 100, Intergovernmental Review of Department of Health and Human Services Programs and Activities. E.O. 12372 sets up a system for state and local government review of proposed Federal assistance applications. Applicants (other than federally recognized Indian tribal governments) should contact their State Single Point of Contact (SPOC) as early as possible to alert them to the prospective applications and receive any necessary instructions on the state process. For proposed projects serving more than one state, the applicant is advised to contact the SPOC of each affected state. A current list of SPOCs is included in the supplemental instructions (States without a SPOC do not participate in this process) or at http://www.whitehouse.gov/omb/grants/spoc.html. The SPOC must be given 60 days to review a construction grant application. Applicants are to provide the SPOC with a copy of the application NOT LATER THAN the time the application is submitted to the Center for Scientific Review (CSR), NIH. Applications submitted to NIH in response to this solicitation must contain either SPOC comments or documentation indicating the date on which the application was submitted to the SPOC for review. The SPOC comment period ends 60 days after the application receipt date. The granting agency does not guarantee to "accommodate or explain" state process recommendations it receives after that date. All SPOC comments must be forwarded to both the applicant and to the NCRR Program Official listed under INQUIRIES. If comments are provided by the SPOC, the applicant may wish to submit to the NIH a statement of its reaction to the comments and any appropriate changes to its application. If no response is received from the SPOC by the end of the 60 days allotted for review of the application, the applicant must notify the NIH that no response was received. o Public Disclosure Applicants must make a public disclosure of the project by publication and describe its environmental impact at the time the SPOC is notified. It is suggested that the notice be published in a large-circulation newspaper in the area. This public disclosure is required by Section 102 of the National Environment Policy Act (NEPA) of 1969 and by Federal Executive Order 11514. An example is provided in the "Applicant Information and Supplemental Instructions". o Design Standards Design requirements serve to protect the health and safety of persons using the proposed facility, assure that the new facility is accessible to and useable by the physically handicapped, control the project's impact on the natural environment, conserve energy resources, achieve economy in construction costs, and protect against natural disasters such as earthquake and flood. o Design Schedule Requirements The NIH extramural research facilities construction grant (C06) 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 complete the three design phases leading to the development of the construction document (CD) within the first budget period of the award (completion of the design phases in less than two years is acceptable). Grantees should allow four to six weeks for the NIH review of each design submission. Grantees must submit all design documents for approval by the NCRR/NIH and the grantees must adhere to the following design document approval schedule: o Schematic Designs (35% complete): 6 to 12 months o Design Development (65% complete): 12 to 18 months o Construction Document (95% complete): 18 to 24 months Failure to meet the above required design document approval schedule places the grantee in non-compliance with the requirement of the award. 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 appropriate national advisory council or board REVIEW CRITERIA Review Considerations Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NCRR. Those applications judged to be unresponsive, incomplete, or ineligible will be returned to the applicant. Applications that are complete and responsive 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 using the review criteria stated below. As part of the initial merit review, a process may be used by the initial review group in which all applications receive a written critique and receive a second level review by the National Advisory Research Resources Council. Applications will be evaluated on the basis of criteria intended to assess the following overall questions: (1) To what extent will the proposed change in the research environment facilitate the applicant institution's ability to conduct, expand, improve, or maintain biomedical/behavioral research? (2) Explain how the proposed project will meet unmet national health needs for biomedical/behavioral research, research training and/or research support facilities? Reviewers will also consider the following factors: o 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. o The impact of the proposed construction on the planned advancement or expansion of the research and research training activities at institutions with limited PHS support. o Appropriateness and suitability of the proposed facilities, including safety and biohazard aspects, for the research to be conducted and/or research support and training to be provided. o Specific deficiencies in the existing research facilities that would be remedied and the impact of the proposed project on current and future research activities. o The appropriateness of the proposed physical location and layout of the new facility and the reasonableness of the proposed time-course, cost and sequence for the construction. o Adequacy of the proposed administrative arrangements with respect to institutional commitment to use the space for biomedical/behavioral research, research training and/or research support and the capabilities of the Principal Investigator and staff for scientific and fiscal administration of the facility. Facility design considerations: Architectural: o Conformance to NIH Guidelines, National Life Safety Code and local codes o Occupancy category o Site adjacency and National Fire Protection Agency compliance o Building zoning/adjacency such as public, semi-private, private o Functional adjacency o Proposed conceptual layout o Net and gross square feet of proposed layout o Biological Safety Level Category o List of containment devices in each room o Traffic pattern (users, material, animal, patients) o Hazardous waste management o Waste management o Pest management control o Coordination between all disciplines Mechanical: o Proposed HVAC system (equipment, distribution) o Proposed Hydronic system (equipment, distribution) o Proposed room by room pressurization control o Proposed vibration and noise control criteria o Proposed room by room temperature and humidity control o Proposed HVAC system operation during normal and emergency cycle o Scientific program standard operating procedures (SOP) during HVAC system failure Plumbing: o Proposed specialty systems (water purification, animal water feed, special liquid or gases) o Proposed potable and non-potable water systems Fire Protection: o Proposed fire protection barriers o Proposed sprinkler system o Proposed fire alarm system Electrical: o Conformance to National Electrical Code o Proposed electrical distribution system (normal, emergency, UPS) o Proposed room lighting o Proposed security system o Proposed telephone/data/LAN distribution system o Proposed equipment monitoring system List of references for the design of facilities supported through the Research Facilities Improvement Program: o NIH Design and Policy Guidelines, http://des.od.nih.gov o Primary Containment for Biohazards: Selection, Installation and Use of Biological Safety Cabinets, CDC/NIH o Biosafety in Microbiological and Biomedical Laboratories, CDC/NIH o Guide for the Care and Use of Laboratory Animals, National Research Council, National Academy Press, Washington, D.C. 1996 Specific Considerations in Writing and the Review of the C06 Application The schematic line drawings must be part of the application and easy to read. Drawings must clearly indicate all construction and renovations. Safety aspects must be incorporated in the design. The facility location must be identified with regard to related research facilities. The drawings must indicate egress routes and the relationship of rooms. All related specialized facilities and the location of major equipment must be shown. Provide an organizational chart of the institution that defines the administrative authority. Fully justify the cost of the construction. Provide precise cost estimates and vendor quotes when available. Justify the space requirements for support staff. Clearly describe the impact of the proposed construction on PHS-funded research for both existing and future research projects. Provide a table that list current and pending research grants and indicate 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. The narrative of the application is limited to 40 pages. Line drawing are include in the narrative, but are not counted against the 40-page narrative limitation. Provide succinct descriptions of specific research activities that will benefit from the proposed construction. Do not provide a description of global research activities at the institution. Provide biographical sketches (4 pages including other support) of only investigators who will be major users of the proposed facilities, the principal investigator and the program director. A table which details the research support to benefit from the proposed improvement project is required in the application in addition to the 4-page biographical sketches. 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 o Rate charts Special considerations for an animal facility should include: o A detailed description of any biohazard issues. o A description of the veterinary support. o The training and continued education programs for veterinary staff. o A detailed animal census. o A description of which animals are used for each project. o A description of the composition and procedures of the IACUC. o A description of appropriate procedures to ensure that the facility will be used as intended. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. Factors considered in making awards include the merit of the proposal as determined by peer review; the needs of the institution, with special consideration for small institutions as well as institutions designated as Centers of Excellence; the commitment by the institution of funds needed to complete the project; the availability of appropriated funds; prior receipt of a construction award from this program; and geographic distribution. Award Conditions The grantee will begin a process of design approval with the NIH Division of Engineering Services (DES) after acknowledging receipt of the Notice of Grant Award. This consists of three stages of submission of design documents. Two sets each of Schematic Design, Design Development and Final Construction Design Documents will be submitted at Stages 1, 2, and 3, respectively. The documents will include detailed cost estimates and are required for final review and approval by the DES and NCRR before bids and proposals can be solicited by the grantee for the construction contract. Advertisement for construction bids and construction may be initiated only after receipt of the construction grant award and subsequent approval of the working drawings and specifications by NCRR staff. Early in the design process, applicants are encouraged to review the "NIH Grants Policy Statement," which is available on-line at https://grants.nih.gov/archive/grants/policy/nihgps/policy_stmt.htm. The sections related to public policy requirements and construction (i.e. Part III) are particularly relevant. NO REQUESTS TO INITIATE CONSTRUCTION, CONSISTENT WITH NIH POLICY, WILL BE ENTERTAINED PRIOR TO RECEIPT OF A CONSTRUCTION GRANT AWARD FROM NIH AND SUBSEQUENT APPROVAL OF WORKING DRAWINGS AND SPECIFICATIONS BY NCRR STAFF. The facility must be utilized for biomedical or behavioral research purposes for which it was constructed for at least 20 years beginning 90 days following completion of the construction project. Any lease agreement must cover a time period sufficient for the usage requirement and be a minimum of 20 years in length from the completion of the facility. An annual progress report is required for 20 years Federal interest in the facility as a condition of this award and must include a list of publications "originating from the use" of this project facility. This list should be limited to those scientific papers acknowledging NCRR support including grant numbers. Failure to comply with the 20-year utilization requirement will result in recovery of the Federal share of the value of the facility in accordance with Federal Regulations at 45 CFR 74.32. 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 https://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. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.389. Awards are made under authorization of Sections 481A and 481B of the Public Health Services Act, as amended by Sections 303 and 304 of Public Law (PL) 106-505 and administered under the NIH grants policies and administered under the NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm and Federal Regulations 42 CFR 52 and 45 CFR Part 74. Applicants are required to comply with Executive Order 12372 as supplemented by 45 CFR Part 100, Intergovernmental Review of Health and Human Services Programs and Activities. 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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