REGIONAL BIOCONTAINMENT LABORATORIES (RBL) CONSTRUCTION PROGRAM RELEASE DATE: June 29, 2004 RFA Number: RFA-AI-04-032 EXPIRATION DATE: December 30, 2004 Department of Health and Human Services (DHHS) PARTICIPATNG ORGANIZATION: National Institutes of Health (NIH) ( COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Allergy and Infectious Diseases (NIAID) ( CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: No. 93.389, NIH Construction LETTER OF INTENT RECEIPT DATE: November 29, 2004 APPLICATION RECEIPT DATE: December 29, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Background and Objectives o Mechanism of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE OF THIS RFA The National Institute of Allergy and Infectious Diseases (NIAID) invites applications for Construction Cooperative Agreement (UC6) funds to support the construction of new Regional Biocontainment Laboratories (RBLs) to be used for biomedical research and research training. Funds will be provided to program, design, construct, and commission comprehensive state-of-the-art laboratories that will support research on the NIAID Category A, B and C priority pathogens and emerging infectious diseases. At a minimum, the facility must include biosafety level-3 (BSL-3) and biosafety level-2 (BSL-2) biomedical research laboratories, a vivarium for small animals, and support space for research, administration, and building operations. The RBLs must preferentially support NIAID-funded biodefense and emerging infectious diseases research and will be members of the NIAID Biodefense Network. Additionally, the RBLs will serve as a regional resource for research institutions in the area, and must be available and prepared to assist national, state, and local public health efforts in the event of a bioterrorism emergency. PUBLIC BRIEFING The NIAID will hold an informational session for individuals representing institutions considering submission of applications in response to this RFA. The session will be held on Tuesday, July 27, 2004 from 9:00AM to 12:00noon in Room 1205, 6700B Rockledge Drive, Bethesda, Maryland 20817. Staff rom the NIAID Biocontainment Laboratories Program and from the Division of Extramural Activities will provide information about the program and will be available to answer questions pertinent to preparing applications. Advance registration is not required. BACKGROUND AND OBJECTIVES To focus attention on the agents that pose great risks in the event of a bioterrorist attack, the NIAID compiled a list of the Category A, B, and C priority pathogens ( A strategic plan defining short and long-term goals aimed at protecting the United States against attacks using these agents was developed in consultation with a Blue Ribbon Panel on Bioterrorism and Its Implications for Biomedical Research ( The NIAID strategic plan emphasizes basic and translational research that will lead to the development of new diagnostics, therapeutics and vaccines. The Blue Ribbon Panel further identified a critical need to expand the availability of research resources to support implementation of the Biodefense Research Agenda of NIAID. Since a major challenge in meeting the goals of the Agenda is the serious shortage of high-containment laboratories, NIAID has established the Regional Biocontainment Laboratories Construction Program. The objective of this Program is to build new, stand-alone, state-of-the-art laboratory facilities to expand the national capacity to conduct biomedical research requiring BSL-3 biocontainment. Funds will be provided to support programming, design, construction, commissioning, and installation of fixed equipment into new, comprehensive biocontainment facilities containing BSL-3 laboratories, BSL-2 laboratories, vivarium, and research support (administration, operations, etc.) space. The RBLs must include small animal facilities and must meet minimum size requirements (see below). GLP compliance capabilities are encouraged, as are facilities to conduct non-human primate studies and aerobiology. These RBL facilities are intended to provide support for NIAID-funded research in biodefense and emerging infectious diseases, and are to serve as a regional resource to all NIAID-approved research organizations in the area. The RBLs also will participate in the NIAID Biodefense Network, and must be available and prepared to support public health efforts in the event of a biodefense emergency. The NIAID Biodefense Network is comprised of the Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases (RCEs), as well as the National and Regional Biocontainment Laboratories (NBL/RBLs). Awards were made in 2003 to establish eight RCEs ( Each RCE consists of a consortium of universities and complementary research institutions serving a particular geographical region. The RCEs support research and development activities that promote scientific discovery and translational research to create the next generation of therapeutics, vaccines, and diagnostics for the NIAID Category A, B and C priority pathogens. In 2003, NIAID also awarded funds for the construction of two National Biocontainment Laboratories (NBLs) and nine Regional Biocontainment Laboratories (RBLs) ( The NBLs will serve as a national and regional resource for research on biodefense and emerging infectious disease agents that require BSL-4/3/2 biocontainment, while the RBLs will serve as a regional resource for research requiring BSL- 3/2 biocontainment. The NBLs and RBLs will be available to assist public health officials in the event of a bioterrorism emergency. Participants in the NIAID Biodefense Network will include NIAID Program staff, and representatives from the RCEs, NBLs, and RBLs. The Network will help define the direction and scope of biodefense and emerging infectious disease research activities within the RCEs and NBL/RBLs, with centralized coordination through the RCE Program Office at NIAID. The current solicitation will augment the Network by providing additional BSL-3 biocontainment capacity to support the NIAID biodefense and emerging infectious diseases research efforts, however association with an RCE is not required. MECHANISM OF SUPPORT This RFA will use the NIH Construction Cooperative Agreement (UC6), an "assistance" mechanism, rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. The applicant will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. The anticipated award date is August, 2005. The NIH UC6 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award". This RFA uses just-in-time concepts and non-modular budgeting formats. This program does require cost sharing as defined in the current NIH Grants Policy Statement at The total project period for applications submitted in response to this RFA may not exceed five years. FUNDS AVAILABLE The NIAID intends to commit approximately $125 million in FY 2005 to fund 5 to 8 new awards in response to this RFA. Only applications requesting funds to build stand-alone facilities at a single site will be considered responsive to this RFA. An applicant may request a project period of up to 5 years (with all funds to be obligated within 5 years of the date of award). No facilities and administrative (F&A) costs will be awarded. NIAID will not provide funding to support the operation of the facility. Because the nature and scope of the proposed facility will vary from application to application, it is anticipated that the size and duration of each award will vary. Each award will have a Federal share of $15 to $25 million. Matching funds of at least 25% of the total allowable costs of the project must be provided by the applicant institution. Although the financial plans of the NIAID include support for this program, awards pursuant to this RFA are contingent upon the availability of appropriated funds, NIAID appropriations authority provided at the discretion of Congress, and the receipt of a sufficient number of meritorious applications. At this time, it is not known if this RFA will be reissued. ELIGIBLE INSTITUTIONS The applicant may submit (an) application(s) if the institution has any of the following characteristics: o Non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories Foreign and Federal institutions are not eligible to apply. Current NBL and RBL awardees are not eligible to apply. INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the proposed project is invited to work with his/her 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. It is advisable that the Principal Investigator be a highly placed institutional official, at the level of Dean or equivalent, who has responsibility and authority for research activities at the applicant organization, as well as the authority to commit institutional funds and resources. SPECIAL REQUIREMENTS 1. Sources of Funding: A description of the anticipated sources of the non- Federal funding for the project (both matching funds and funds needed to complete the total project) must be provided with the application, including a letter from an appropriate institutional official (authorized to commit funds at the institution) committing the matching funds and assuring that they will be in-hand prior to an award. The minimum match requirement will be $1 (awardee) to $3 (Federal). Only applications proposing a Federal share of $15 to 25 million will be accepted. No facilities and administrative (F&A) costs may be requested, nor will any facilities and administrative costs be awarded. Organizations may contribute more than the required matching funds to allow for larger projects. Existing assets may not be used as matching funds; examples of unallowable existing assets include the value of currently owned land, land acquisition costs, existing infrastructure, existing buildings, equipment, and off-site improvements (see unallowable costs, 2. Overall Facility Requirements: The proposed facility must be a stand-alone comprehensive research laboratory building at a single site with a single project footprint. It must have a minimum size of 30,000 gross square feet (GSF) that will provide flexibility and adaptability in meeting the needs of the NIAID Biodefense Agenda. The RBL must incorporate defined public, laboratory, vivarium (limited to small animal and non-human primate facilities), and support zones including appropriate research, information technology, administrative support, and conference space. Additions to existing buildings, completion of uninhabitable shell space in new or existing buildings, and major alterations and renovations are not allowed. Major renovations and alterations may be funded through other initiatives ( The acquisition and installation of fixed equipment, such as casework, fume hoods, large autoclaves, or biological safety cabinets, is allowed. 3. Animal Facility Requirements: High-level biocontainment animal facilities for multiple small species are required, while those for non-human primate models are encouraged. The facilities must be planned and designed to allow for maximum flexibility and adaptability for protocols requiring work with both infected and uninfected animals. The facilities shall include all required program spaces to support the mission of the RBL, i.e., animal holding areas, procedure rooms, surgical suites, necropsy room, and all other required vivarium support such as a cage wash, autoclaves, a tissue digester, food and bedding storage, medical pathological waste storage, and a loading/receiving area; as appropriate. The design also should include BSL-2 laboratory space, as appropriate, to support the BSL-3 laboratories. Facilities to conduct aerobiology work and capability for GLP compliance also are encouraged. Facilities for large animals (bovine, equine, ovine, etc.) and BSL-3AG facilities will not be supported. 4. Overall Facility Design: The RBL design should maximize operational effectiveness, efficiency and space utilization, and create a high-quality, state-of-the-art work environment that is appropriate for biomedical and microbial research. The facility must be reliable, adaptable, and sufficiently flexible to serve multiple users and their unique user requirements related to biocontainment, and should accommodate changing future research needs. 5. Utilities Infrastructure: The existing site utilities infrastructure must be adequate to ensure reliability in supporting the proposed facility. Emergency and standby power and 100% redundant mechanical, electrical, and plumbing systems must be provided to meet the safety needs of the occupants and the surrounding community. The redundancy requirement includes site utilities, primary mechanical and electrical equipment, and distribution systems. Each piece of equipment and its related components should be capable of being totally isolated from the remaining operational units to accommodate routine maintenance and emergency repairs, as well as designed to ensure continuous operation during equipment failure and scheduled maintenance outages. The equipment serving these systems shall be designed to a minimum of "N+1" redundancy. Piping systems shall be designed for flexibility and have redundant components and risers to provide reliable and continuous operation. Emergency/stand-by generators and distribution systems must be provided to support the intended use and critical nature of the facility. 6. Security System Requirements: Biocontainment facilities and research support laboratories must be designed to maximize safety in the work space and surroundings. Stringent security and access control must be provided for the building and coordinated with existing security system infrastructure and operations, as appropriate. The NIAID’s primary security objectives for the RBL program are the safety and protection of the general public and environment, security of the select agents, and preserving the integrity of biocontainment. The safety and security of personnel; protection of the property, research and animals; and potential damage or destruction to the facility, must all be addressed. It is the awardee’s responsibility to ensure that these objectives are satisfied. In preparation for submitting an application, the applicant institution should conduct a preliminary security assessment to be utilized in developing security measures for the proposed building. Post-award, each grantee will be required to perform a site-specific and project-specific Threat and Risk Assessment (TRA) to develop a security plan. This TRA shall include using the services of a qualified TRA professional. The TRA will become the basis for addressing individual security issues. The TRA should identify and quantify potential threats, both internal and external to the building, its contents, the personnel working in it, and the general public. The analysis should include a thorough examination and evaluation of the physical aspects of the proposed facility, along with operational issues. Based on the TRA, the awardee shall establish security measures to ensure that the security objectives of the NIAID’s National Biodefense Program are achieved. A copy of the TRA along with a list of the proposed security measures shall be submitted to the NIAID. The security measures, as established by the TRA, for each RBL will be incorporated into the design and operation plan for the facility. The NIAID will review these documents during the regular design submittals for compliance. NIAID also will monitor construction and the certification process for conformance with the security measures established by the awardee to assure the facility is safe and secure when completed and in operation. 7. Requirements for Meeting Local, State and Federal Codes and Guidelines: Design features shall meet or exceed: current codes (local, state, Federal); current certification standards; standards in the latest version of the NIH Design Policy and Guidelines (; biosafety requirements and standard procedures found in the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL), most current edition (; and the requirements resulting from the Select Agent Rule and related issues ( Plans must provide facilities that will allow for adherence to the most stringent interpretation of the BSL-3 biosafety requirements in the BMBL. The design must allow for work with radioactive isotopes in accordance with applicable rules and standards. 8. The awardee institution must work effectively, efficiently and in a cooperative manner with government personnel, government contractors and all necessary subcontractors (e.g. architect/engineers, designers, general contractors, consultants, construction managers) involved in development, planning, design, construction and commissioning activities to complete the project on an aggressive schedule, as approved by NIAID. Consistent with applicable laws and award terms, the project will be completed at the most reasonable cost to the government by bringing the best available commercial practices to the project in collaboration with NIAID. 9. Design Review and Approval Process: Following award notification, the awardee will begin a process of design review and approval with NIAID program staff and other designated NIH personnel. This process consists of the following required stages of design document submission. a. programming, schematic design (15%), and basis of design documentation b. design development (35%) c. construction document (75%) d. final construction document (100%) Approximately twenty sets each of documentation will be required at each stage of design document submission. Additionally, a formal conceptual design (15%) presentation will be required. For each submission stage, the documents will include detailed cost estimates that are required for final review and approval by NIAID staff before bids and proposals can be solicited by the awardee for the construction activities of the project. Advertisement for construction bids and construction may be initiated only after approval of the final construction documents (100%) by NIAID staff. Please note that the NIAID must approve any plans that include a construction management contract with a guaranteed maximum price (GMP) clause. In addition, advertisement for construction bids and construction can be initiated only after receipt of the construction grant award and subsequent approval of the working drawings and specifications by NIH staff. Early in the project development process, applicants are encouraged to review the NIH Grants Policy Statement ( The sections related to public policy requirements and construction (i.e., Part III) are particularly relevant. Consistent with NIH policy, no requests to initiate construction will be entertained prior to receipt of a construction award from NIH and subsequent approval of working drawings and specifications by NIAID staff. 10. The RBL shall be commissioned in accordance with the NIH Model Commissioning Guide: 11. Facility Usage Requirements: The facility must be utilized for biomedical research purposes as determined by NIAID program needs for at least 20 years beginning 90 days following the completion of the project. Any land 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. Federal interest in the facility must be acknowledged as a condition of this award. An annual progress report is required for 20 years and must include a list of publications originating from the use of this facility. This list should be limited to those scientific papers acknowledging NIAID support including grant/or contract 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. The NIAID will not provide funds for the operation of the facility. Additionally, RBLs must be ready and available to provide facilities, scientific support and expertise to first-line responders and be available and prepared to support public health efforts in the event of a national biodefense or emerging infectious diseases emergency. 12. Community Relations Plan: The RBL applicants must have a plan to establish and maintain a strong community relations effort throughout the planning, design, construction and operation of the facility. Proactive positive relations will be developed and maintained with the research community, the award recipient’s community, surrounding residential/commercial communities, and the general public throughout the application process, construction and operation of the facility. A detailed description of the plan must be provided as part of the application. 13. Research Base: The applicant organization must be associated with investigators funded by NIAID to conduct biodefense and emerging infectious diseases research and training. Association with an existing RCE is not required. Applications should document a research base of currently funded and/or planned research activities and the involved personnel and institutions that will make use of the proposed biocontainment facilities. This may include a consortium of institutions, including industry partners. However, there can be only one applicant institution, which will be responsible for construction, ownership, and operation of the facility under this RFA. 14. NIAID Biodefense Network Participation: RBLs will participate in the NIAID Biodefense Network, which consists of the NIAID Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research Program, the National Biocontainment Laboratories, and the Regional Biocontainment Laboratories. Representatives will be required to attend regular meetings of Network members, and additional meetings, as needed, in the event of a bioterrorism emergency. 15. Site Visits: The NIH reserves the right to conduct site visits when deemed necessary. This may include site visits during the application evaluation process, post-review and prior to award, during the design and construction process, and during operation of the laboratory. Alternatively, or in addition, visits to NIH by representatives of the awardee institution may be required. Any site visits may involve other government officials or contractors representing NIH. 16. National Environmental Policy Act Requirements: The National Institutes of Health (NIH) is required to follow The National Environmental Policy Act (NEPA) process for any major action that utilizes federal funds or federal property. Due to the nature of these projects, the NIH is requiring the applicants to complete and submit the NIH NEPA checklist. The determination of whether an Environmental Impact Statement (EIS) or Environmental Assessment (EA) is completed, or No Further Action is required, is the responsibility of NIH. The NIH will have full review, recommendation, and approval of the process and/or reports; however, the awardee will be required to initiate the environmental review and provide backup documentation. The NIH will act as a source of reference and assistance in the procedures and retains the final decision for the NEPA process. The NIH will assess the level of environmental impact of proposed projects using the information submitted as described in All applications must be accompanied by an analysis; applicants may use the suggested sample format. The analysis is intended to convey available environmental information with the initial grant application and does not require expenditure of funds for extensive consultant services prior to a grant award. Therefore, the hiring of special consultants for developing detailed data and elaborate presentations is discouraged. The analysis should be accompanied by a current listing of all relevant licenses, permits, and/or other approvals required. Copies of all such documents should be submitted with the environmental analysis. This would include, but not be limited to, the state and local air, water quality, and zoning board reports. Also, indicate the state, local, and regional planning authorities contacted or consulted regarding the application and briefly discuss the proposed facility with respect to regional development plans. The awardee will complete any further required environmental assessments or impact statements as determined by the NIH. 17. State and Local Government Review Requirements: Applicants are required to comply with Executive Order (E.O.) 12372 as supplemented by DHHS 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 (SPOCs) as early as possible to alert them about the prospective application and receive any necessary instructions on the State process. (See For proposed projects serving more than one State, the applicant is advised to contact the SPOC of each affected State. The SPOC must be given at least 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, NIH. Include, as appendix material to the application, all comments received from the SPOC during pre-application coordination. 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" for State process recommendations it receives after that date. All SPOC comments must be forwarded to the applicant and to the NIAID fiscal contact given in the RFA. 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. 18. Public Disclosure Requirements: Applicants also 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 Environmental Policy Act (NEPA) of 1969 and by Federal Executive Order 11514. One example of a suitable disclosure statement follows; however, the choice of presentation is at the discretion of the applicant: "PUBLIC NOTICE" "Notice is hereby given that the Uptown Medical School proposes to construct additional space, partially utilizing Federal funds. The proposed construction project is the addition of 2,700 square feet connected to the existing Allen Building, which is located at 5333 Main Street, Downtown, Ohio. "The Medical School has evaluated the environmental and community impact of the proposed construction. There will be construction noise and increased construction traffic during the construction period. No significant permanent environmental impacts are foreseen. All building permits and zoning approvals have been obtained. "In accordance with Federal Executive Order 11514, which implements the NEPA of 1969, any individual or group may comment on, or request information concerning, the environmental implications of the proposed project. Communications should be addressed to the Office of Planning, Uptown Medical School, and be received by (date). The Federal grant application may be reviewed at the Office of the Dean, School of Medicine, 5333 Main Street, during working hours." COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD The following terms and conditions will be incorporated into the award statement and provided to the Principal Investigator as well as the institutional official at the time of award. These special Terms of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR part 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is the Construction Cooperative Agreement (UC6), an "assistance" rather than an "acquisition" mechanism, in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient's activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. Consistent with this concept, the dominant role and prime responsibility for the activity resides with the awardees for the project as a whole, although specific tasks and activities in carrying out the research will be shared among the awardees and the NIAID Program Coordinator. 1. Awardee Rights and Responsibilities a. Awardees will have primary responsibility for the project as a whole, including all phases of design and construction, and working with NIH staff and contractors as needed. b. Awardees agree to participate in projects identified by the NIAID Biodefense Network that include common research interests and address a specific biodefense problem or threat. c. The Principal Investigator must attend and participate as a voting member in regular meetings of the NIAID Biodefense Network to discuss progress and directions of research and to ensure that overall NIAID Biodefense Agenda goals are being met. d. The Principal Investigator must participate, as needed, in regular, local meetings of the RBL and its research partners to discuss progress and directions of research and to ensure that the necessary interdisciplinary interactions are taking place. Additionally, the Principal investigator must ensure that the facilities of the RBL are utilized to the fullest extent possible and that procedures remain in place to make facilities available to qualified users in the region. e. Each RBL will submit an annual progress report to the NIAID that describe activities and accomplishments during the previous funding/reporting period and attend an annual program meeting. f. All awardees must adhere to the Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (64 Federal Register 72090). The Principles and Guidelines can be accessed electronically at: 2. NIAID Program Staff responsibilities: a. The role of NIH staff in the cooperative agreement arrangement is to support and stimulate the recipient's activities by substantial involvement as facilitators in the process without assuming responsibilities that remain with the Principal Investigator. The RBL Program Staff members from the NIAID Division of Microbiology and Infectious Diseases assigned to each RBL as NIAID Program Coordinator(s) will work closely with the Principal Investigator to develop and approve plans for construction of the facility, facilitate the collaborations with other NIAID-funded research groups and to leverage the resources available in the RBL. b. The NIAID Program Coordinator(s) will monitor the progress of the RBL program, assist in coordinating activities between the RBLs, and contribute to the adjustment of research projects or approaches as warranted. The NIAID Program Coordinator(s) will assist and facilitate this process and not direct it. The NIAID Program Coordinator(s) will also provide assistance with all major transitional changes of RBL activities prior to implementation to assure consistency with the overall goals of the RBL Program and the NIAID biodefense mission. When appropriate, issues may be brought to the NIAID Biodefense Network for discussion. c. The NIAID RBL Program Coordinator(s) will assist in organizing an annual meeting of investigators from all funded RCE/RBL/NBLs to share progress and research insights that may benefit all of the projects. d. Other NIAID staff will be responsible for normal program stewardship and monitoring of award. 3. Collaborative responsibilities: a. The NIAID Biodefense Network will provide overall scientific coordination of the RBL Program; RCE Principal Investigators, Directors of the RBL/NBLs, and the NIAID two RCE/NBL/RBL Program Coordinator(s) will be members. Additional NIAID Program Staff and scientists other than Principal Investigators may attend as non-voting members of the committee, when additional expertise may be required. b. The NIAID Biodefense Network will meet at least once a year, or as needed in the event of a bio-terrorism emergency event. The purpose of these meetings is to share scientific information, to assess scientific progress, to identify new research and development opportunities and potential avenues of collaborations such as with industry, private foundations, NIH intramural scientists, and other federal government agencies, and to establish priorities that will accelerate the translation of preclinical findings into clinical applications, reallocate resources and conduct other business of the RCE/RBL/NBL Programs. c. The Network will be called upon to make recommendations regarding approaches to specific threat agents and emerging infectious diseases that require new attention as the need arises. The Network will seek input from the scientific research communities, and assist the NIAID in determining initiatives that will have an impact on the health and safety of the nation. The Network will also provide a forum for coordinating RCE/RBL/NBL activities that require a liaison function with other federal agencies such as FDA, USDA, and CDC. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and IC may be brought to arbitration. An arbitration panel will be composed of three members one chosen by the awardee, a second member selected by the IC, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into several areas: design/construction, scientific/research, peer review, and financial or grants management issues. It is highly recommended that appropriate NIAID program staff be consulted before submitting the letter of intent and during the early stages of preparation of the application. (See program contacts under INQUIRIES). o Direct questions about design/construction issues to: Nancy Boyd Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 5015, MSC-6603 6610 Rockledge Drive Bethesda, MD 20892-6603 Telephone: (301) 402-8585 FAX: (301) 480-1263 Email: o Direct questions about scientific/research issues to: Alicia Dombroski, Ph.D. Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases Room 5005, MSC-6603 6610 Rockledge Drive Bethesda, MD 20892-6603 Telephone: (301) 402-8561 FAX: (301) 480-1263 Email: o Direct questions about peer review issues to: John Bogdan Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3258, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: (301) 402-7372 FAX: (301) 402-2638 Email: o Direct questions about financial or grants management matters to: Lesia Norwood Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 2117, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: (301) 402-7146 FAX: (301) 480-3780 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 project o Name, address, e-mail 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 NIAID 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: John Bogdan Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3258, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 (20817 for express mail or courier service) Telephone: (301) 402-7372 FAX: (301) 402-2638 Email: SUBMITTING AN APPLICATION Applications must be prepared using Standard Form (SF) 424 and 424C (, as well as continuation pages and other materials described in the supplementary instructions noted below. Complete the application following the instructions included with the 424 application form, except as noted below. Applications must have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the Universal Identifier when applying for Federal grants or cooperative agreements. The DUNS number can be obtained by calling (866) 705-5711 or through the web site at The DUNS number should be entered in item 5 on the SF424 cover page. The PHS 398 document is available at in an interactive format. For further assistance contact Grants Info, Telephone (301) 710-0267, Email: SUPPLEMENTARY INSTRUCTIONS: The sections of the application must be presented and numbered in the following order: 1. SF 424 Face-sheet (page 1 of the application) Item 5. Person to be contacted - Identify the Principal Investigator. The Principal Investigator should be an institutional official, at the level of Dean or equivalent, who has the responsibility for allocation of space and resources for the project addressed in this application, and can provide the necessary assurances and commitments. In addition, an institutional business official contact should also be provided, as described in Section 5, below, of these instructions, "Budget (Additional information required)." Item 9. Enter "National Institutes of Health." Item 10. Program - The CFDA number for this program is 93.389; Type "NIH Construction" as the title. Item 11. Descriptive Title of Applicant's Project; Enter " RFA-AI-04-032 Regional Biocontainment Laboratory. Item 13. Enter xx/xx/2005 through xx/xx/20xx. The entire project period may not exceed five years. Item 15. Estimated Funding - a. Enter the amount from item 17 on application page SF 424C. A Federal share of $15 million to $25 million is required. b. Applicant: Use this line to indicate the difference between item 15a. above and 15g. below. g. TOTAL: Enter the amount shown on line 16, column "a" on page SF 424C. Item 16. The research facilities construction programs of the NIH are subject to Executive Order 12372. 2. SF 424C, Budget Information (Page 2 of the application) Note that costs associated with purchase of land or offsite improvements are not eligible for Federal funding, nor may these costs be used to satisfy matching requirements under this initiative ( Line 10. Equipment -Enter the total cost of only fixed equipment such as cabinets, sinks, fume hoods, and other built in equipment items that are essential to this project. Line 11. Miscellaneous -Enter the amount requested for all other costs in the appropriate columns. Line 13. Contingencies - The PHS allowable contingency is limited to five percent of the eligible project costs as defined above. The contingency fund is established to provide for unforeseen problems. Following the award of the construction contract by the grantee institution, the PHS funded contingency is reduced to two percent of the eligible project costs. Line 17. Federal Assistance Requested. The Federal percentage share is up to 75 percent for all applications submitted in response to this RFA. However, the amount of Federal assistance requested may not be less than $15 million or more than $25 million. 3. Table of Contents (page 3 of the application) 4. Program Overview (page 4 of the application.) Provide a concise (250 words or less) overview description of the proposed project stating long-term objectives and specific aims. 5. Budget (additional information required) Use a blank continuation sheet(s) to provide the following information which should be numbered beginning as Page 5 of the application. Indicate the composition of funds shown in Item 15.b. on the SF 424 face-sheet broken down as follows: (1) bonds authorized but not yet sold; (2) net amount of cash available free from claims; (3) cash value of pledges already made but unpaid (i.e., the face value) and the amount for which the pledges can be discounted by a bank or lending agency (i.e., the discounted value). A statement from the bank or lending agency should be attached giving the bank's estimate of the discounted value of the pledges; (4) total amount of contingent gifts and bequests with a description of the contingency; and (5) other proposed methods of applicant financing. This section should sufficiently detail the source(s) of non-Federal funding for the project (both matching funds and those funds that are necessary to complete the total project). An applicant must provide an assurance that required matching funds are available, and that additional funds have been secured to meet project costs in excess of the Federal award and non-Federal matching amounts before an award may be made. Provide an itemized listing of the costs included on Line 11, Miscellaneous, on Form Page SF424C. Include a detailed justification of the cost of the construction, providing precise cost estimates and vendor quotes when available. 6. Biographical Sketches Using the Biographical Sketch format & instructions provided in the PHS 398 ( provide biographical sketches (2 pages) for the Principal Investigator and key personnel for this project. Do not provide biosketches for anticipated users of the facilities. 7. Description of Planned Facility and Design Plan Justification ( weight: 65%) The following information about the facility design must be included: a. Provide a functional layout of the proposed facility including conceptual drawings to show: the location of the proposed facility in relation to existing buildings and research facilities at the institution, (indicate all building names and addresses); existing utility infrastructure as well as new utility infrastructure required to support the proposed facility; and the layout of each laboratory, office, animal room, or other space including entries and exits, clearances, and location of fixed equipment items such as hoods and autoclaves. Generic laboratory descriptions are not sufficient for technical evaluation. The plans must indicate biosafety level (e.g., BSL-2 or BSL-3) and utilization of space by name or by specific function, e.g., instrument room. Safety and security features must be indicated clearly in the design, as well as egress routes and the relationship of rooms. All related specialized facilities and the location of major equipment must be shown. The conceptual plans must be supported by sufficient descriptions and information to allow evaluation of plans regarding: laboratory design, animal facility design, architectural, structural, mechanical, plumbing, electrical, fire safety, research computer, security/surveillance and building automation systems. The line or schematic drawing(s) must be easy to read, no larger than 8- 1/2"x11", and reproducible by photocopy or similar process. Scales must be clearly indicated on all line drawings. Legibility of the drawings is important. Architect's design development documents and drawings will be requested ONLY if a decision is made to fund the project. They should NOT be submitted with the application. The appropriateness of the proposed physical location and layout of the new facility will be evaluated by scientific and technical reviewers. b. A table showing: o The net square feet in the proposed facility with breakdown by function and biosafety level. The format should encourage the identification of space in relation to the science and the program activity. Where this is not possible, space may be identified as animal research areas (examination rooms, etc.), equipment areas, or centralized/core facilities. o The gross square feet of the new facility. o A summary of space by room type (basic research, office space, etc.). Use the AIA Document D101 Method for Calculating the Areas and Volumes of Buildings (American Institute of Architects, 1735 New York Avenue, N.W., Washington, DC 20006-5292). c. An itemized listing of fixed equipment including cost. d. Design Plan Justification (maximum of 10 pages of text) Include written statements that provide justification for the space allocations and descriptions of design features for each type of laboratory space/area included for the project (BSL-3 facilities, BSL-2 facilities, animal facilities, etc.). e. Projected Time Line Provide a proposed timetable with milestones and associated costs for the project. 8. Project Strategic Plan (weight: 35%; maximum of 20 pages of text) This section must clearly describe the scientific rationale and justification for the proposed facilities, the organizational structure of the institution with specific attention to who will be responsible for this project, and management plans for the design, construction and operation of the RBL. This section has the purpose of providing NIAID staff and the reviewers with the information necessary to judge the overall scope and scientific and technical merit of the project including examples of research activities that would make use of the facility, the appropriateness of the proposed facility for supporting those activities, and the capability of the applicant to pursue the project successfully. The major sections of the narrative must address the following points: a. Provide an organizational chart of the institution and accompanying description that defines the administrative authority of the applicant organization as related to the conduct of this construction project and subsequent operations of the facility. Include an overall plan for the management of the facility construction that describes plans for prioritizing, scheduling and granting access to the facility to investigators in the region, for training personnel to work in the biocontainment facilities, and for fiscal management of the operation of the facility. c. Describe how the facility would support NIAID-funded biodefense and emerging infectious diseases research. Provide succinct descriptions of specific funded or planned research activities/projects that will benefit from the proposed construction (a limit of 15 lines per activity/project described applies to this section). Do not provide a description of global research activities at the institution or consortium. Include a description of regional interactions or relationships that have been established with investigators conducting NIAID-funded research in biodefense and emerging infectious diseases. Supporting documentation should be provided in the form of tables that list current and pending biodefense-related research grants/contracts, including the name of the principal investigator, the title, and the source, amount of funding, and start and end dates. For funded projects, also include the grant/contract number. d. Describe how the facility would contribute to the availability of biodefense research resources at the institution(s) and in the region/nation. Identify unique opportunities for the RBL to contribute to biodefense and emerging infectious diseases research, and identify unmet needs that may be addressed by the planned resources. e. Describe how the facility will develop plans for, and serve as, a regional and/or national resource and be prepared to respond in the event of a national bioterrorism emergency, and how maximum use of the facility will be promoted and implemented. f. Provide a detailed community relations plan outlining initial and ongoing community outreach and involvement related to the intended research activities to be conducted at the RBL. Documentation of community outreach must be provided to the NIAID before award/construction can begin. 9. Applicants must include an opinion from acceptable title counsel describing the interest the applicant organization has in the site and the building and certifying that the estate or interest is legal and valid. If there is a lease, the legal opinion must provide evidence of the existence of a lease agreement which covers a time period sufficient for the usage requirement (20 years beyond completion or occupancy of the project) and that a Federal interest in the building will be recorded for the period of the usage requirement. (Refer also to assurances.) 10. Certification Provide a written certification that the facility will be utilized exclusively for the specific purpose for which it was constructed for at least 20 years beginning 90 days following the completion of the project. Any land 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. Federal interest in the facility must be acknowledged as a condition of this award. An annual progress report is required for 20 years and must include a list of publications originating from the use of this facility. This list should be limited to those scientific papers acknowledging NIAID support including grant/or contract 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. The NIAID will not provide funds for the operation of the facility. Additionally, RBLs must be ready and available to provide facilities, scientific support and expertise to first-line responders and be available and prepared to support public health efforts in the event of a national biodefense or emerging infectious diseases emergency. 11. Personal Data on Principal Investigator Complete and submit the Personal Data form page for the Principal Investigator (, following the instructions on the form page. In accordance with the instructions provided on the form page, do not attach copies of the Personal Data form page to the duplicated copies of the application. Upon receipt of the application by NIH, this page is separated from the application and the data, including the SSN, are encrypted in the NIH database. A partially completed Personal Data form page is acceptable to NIH, i.e., applicants may elect to provide some items but not all. (The Social Security Number is requested for the purpose of accurate identification, referral, and review of applications and for efficient management of PHS grant programs. Provision of the Social Security Number is voluntary. No individual will be denied any right, benefit, or privilege provided by law because of refusal to disclose his or her Social Security Number.) 12. Appendix Materials Photographs, oversized documents, or materials that cannot be photocopied in the body of the application may be submitted as appendices. Also include any comments received from the SPOC during pre-application coordination. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the Checklist, and 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 exact copies of the grant application and all five sets of any appendix material must be sent to: John Bogdan Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room 3258, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 (20817 for express mail or courier service) Telephone: (301) 402-7372 FAX: (301) 402-2638 Email: Applications must be received on or before December 29, 2004. Applications that are not received as a single package on the receipt date will be judged non-responsive and will be returned to the applicant. APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The NIH 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 NIH 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 unfunded version 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 Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIAID. Incomplete and/or non-responsive applications will be returned to the applicant without further consideration or review. 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 NIAID in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Advisory Allergy and Infectious Diseases Council The NIH reserves the right to conduct site visits or reverse site visits when deemed necessary. REVIEW CRITERIA The scientific review group will address and consider these criteria in assigning the application’s overall score. Description of Planned Facility and Design Plan Justification (weight: 65%) 1. Adequacy, feasibility and technical merit of the chosen site; and the plans for design, construction and commissioning of the biocontainment facility. This includes the plans for specialized facilities such as vivarium (including non-human primate facilities), aerobiology, GLP, and other components of the RBL. 2. Adequacy, appropriateness, and suitability of the approaches and methods for ensuring safety, security and biohazard control at the proposed biocontainment facilities. This includes plans for maintaining containment, waste management, compliance with select agent regulations, and safety/security operations plans. 3. Adequacy and feasibility of the plans for the applicant to construct a high-level containment facility in a timely manner including the reasonableness of the proposed schedule for the construction. Project Strategic Plan (weight: 35%) 1. Adequacy, feasibility and merit of the proposed administrative and organizational structure, administrative arrangements, operations plans, financial resources and commitments from institutions within the region to meet the objectives of the project. Adequacy and suitability of the position, training, proposed effort, capabilities and experience of the Principal Investigator and other proposed key personnel for the management and administration of the design, construction, and certification of the proposed facility (this does not include evaluation of future personnel who will be required to operate and maintain the facility). 2. Scientific/technical merit of the local and regional scientific environment with respect to the number and quality of biomedical research investigators and their anticipated needs for the facility. The anticipated effect(s) of the proposed construction on existing and future NIAID supported, research training and /or research support activities. Appropriateness of the plans to make the RBL and its resources available to investigators and institutions throughout the region; to meet current and future local, regional and national needs for facilities to support NIAID funded biodefense and emerging infectious diseases research; and to function as a regional resource and as part of a national response in the event of a biodefense emergency. 3. Adequacy and merit of the proposed community relations plan, including an evaluation of the current status and plans for educating and informing the community. ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score: PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below) INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below). CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed. ADDITIONAL REVIEW CONSIDERATIONS SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data-sharing plan into the determination of scientific merit or priority score. (See instructions and URL to policy in the Federal Citations, below.) 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: November 29, 2004 Application Receipt Date: December 29, 2004 Peer Review Date: May, 2005 Council Review: June, 2005 Earliest Anticipated Start Date: September, 2005 AWARD CRITERIA In addition to Scientific and Technical Merit, other criteria that will be used to make award decisions include: o Availability of funds o Ability to support the desired scope of work o Programmatic priorities o Regional distribution of meritorious applications Prior to award, NIAID may also negotiate to modify the scope of the proposed construction project to meet overall program needs. REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (, as mandated by the Health Research Extension Act of 1985 (, and the USDA Animal Welfare Regulations (, as applicable. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at AUTHORITY AND REGULATIONS This program is described in the Catalogue of Federal Domestic Assistance at in the following citation: No. 93.389, NIH Construction. 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. The NIH Grants Policy Statement is available at This document includes general information about the grant application and review process; information on the terms and conditions that apply to NIH Grants and cooperative agreements; and a listing of pertinent offices and officials at the NIH. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. 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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