REGIONAL CENTERS OF EXCELLENCE FOR BIODEFENSE AND EMERGING INFECTIOUS DISEASES RESEARCH RELEASE DATE: April 1, 2004 RFA Number: RFA-AI-04-018 (Reissued as RFA-AI-08-002) (see NOT-AI-04-026) EXPIRATION DATE: September 10, 2004 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENT OF PARTICIPATING ORGANIZATION: National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS: No. 93.855, Immunology, Allergy, and Transplantation Research No. 93.856, Microbiology and Infectious Diseases Research LETTER OF INTENT RECEIPT DATE: August 9, 2004 APPLICATION RECEIPT DATE: September 9, 2004 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o 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) is expanding the Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) program. The overall goal of the RCE Program is development and maintenance of a strong infrastructure and multifaceted research and development activities that will provide the scientific information and translational research capacity that will lead to the next generation of therapeutics, vaccines and diagnostics against the NIAID Category A-C Agents (http://www.niaid.nih.gov/biodefense/bandc_priority.htm). To realize this goal, the Centers will be provided with support to: 1) develop and conduct programs of investigator-directed research; 2) train researchers and other personnel for biodefense and emerging infectious diseases research activities; 3) develop and maintain comprehensive core facilities that support the research and training activities of the RCE and make these available to qualified investigators from academia, biotechnology companies, the pharmaceutical industry, and other appropriate entities in the geographic region; 4) develop translational research capacity for testing and validating vaccine, therapeutic and diagnostic concepts for biodefense and emerging infectious diseases; and 5) be prepared and available to provide facilities and scientific support to first-line responders in the event of a national biodefense emergency. This Request for Applications (RFA) invites research institutions and groups of investigators to form consortia and develop new applications for research programs which address the fundamental research and development questions expected to yield the information required to counter the threat of bioterrorism. Diverse research and development approaches are encouraged as long as they include the following essential features: a research focus on NIAID Category A-C agents including the incorporation of a translational component with the long term goal of developing products for human use. Additionally, consortia must document: institutional commitment; organizational capabilities; ability to develop and expand facilities; plans for training investigators and other participants in the national biodefense effort; and interdisciplinary coordination and collaboration, particularly linkages to federal, state, and local agencies as well as the private sector. Consortia must have a lead team of individuals responsible for the overall management and direction of the RCE. A group of Center member researchers, with expertise in biodefense and emerging infectious diseases, is required to lead the research thrust which underlies all activities of the RCE. Centers should emphasize the use of cutting-edge approaches and technologies. To ensure that the RCE program contributes maximally and effectively to the NIAID biodefense and emerging infectious diseases effort, the overall direction and scope of activities of the Program and its participant Center sites will be centrally coordinated and monitored by the NIAID Biodefense Network. The Network, which is operated through the RCE Program Office at NIAID, includes the RCE Program Staff, RCE Principal Investigators, and the Principal Investigators of the National Biocontainment and Regional Biocontainment Laboratories (http://www.niaid.nih.gov/newsroom/releases/nblscorrect21.htm) To achieve nationwide distribution of the RCEs, the NIAID will use the 10 established DHHS regions: REGION I: CT, ME, MA, NH, RI, VT REGION II: NJ, NY, PR, VI REGION III: DE, D.C., MD, PA, VA, WV REGION IV: KY, MS NC, TN, AL, FL, GA, SC REGION V: IL, IN, MI, MN, OH, WI REGION VI: AR, LA, NM, OK, TX REGION VII: IA, KS, MO, NE REGION VIII: CO, MT, ND, SD, UT, WY REGION IX: AZ, CA, HI, NV, and the six U.S. Associated Pacific jurisdictions REGION X: AK, ID, OR, WA It is the long-range goal of this program, contingent upon the availability of funds, to establish at least one RCE within each region. NIAID encourages applications from all regions of the country, particularly those that do not have existing RCEs. Applicants from regions with currently funded RCEs should address the additional value of having another Center in the region and how the proposed activities would relate to those ongoing at the established RCE. Although preference is to establish RCEs in those regions that currently do not have one, it is only one of several factors that will be considered in making funding decisions. PUBLIC BRIEFING An informational session for investigators representing groups considering submission of applications in response to this RFA will be held. Details of the meeting will be announced on the NIAID biodefense website (http://www.niaid.nih.gov/biodefense/research/rce.htm) and in the NIH Guide to Grants and Contracts. Representatives from the RCE program and from the NIAID Division of Extramural Activities will provide information and answer questions pertinent to preparing applications in response to this RFA. RESEARCH OBJECTIVES Background As identified by the NIAID Blue Ribbon Panel on Bioterrorism and Its Implications for Biomedical Research and subsequently the NIAID Category A and Category B and C Research Agendas, there is a critical need for the establishment of a highly organized and comprehensive research and development infrastructure with strong translational research capacity (http://www.niaid.nih.gov/biodefense). To achieve this goal, the NIAID established the Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) Program and is expanding it with this RFA. Each Center serves a geographical region and is composed of investigators at several participating universities and/or research institutions, including government and the private sector. The mission of the Centers is research and other activities related to biodefense and emerging infectious diseases. The Centers member researchers are encouraged to collaborate with other NIH- funded investigators within and outside the Center region. In addition, the Centers serve as a focal point to organize and promote relationships with: pharmaceutical and biotechnology companies; federal, state, and local agencies; and other qualified investigators to foster translational research and promote maximal use of the core facilities by a broad range of qualified scientists. In times of a national biodefense emergency, the RCEs will be expected to rapidly realign their activities to assist response efforts within their region. This includes making their core facilities and other resources available to assist in the implementation of national biodefense plans. Objective and Scope This initiative supports the expansion of the Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) for the purpose of developing and maintaining research and development capacity that is needed to assess and counter bioterrorism or emerging infectious disease threats. To accomplish this, the Centers will receive support to: 1) develop and conduct programs of investigator-directed research; 2) train researchers and other personnel for biodefense and emerging infectious diseases research activities; 3) develop and maintain comprehensive core facilities that support the research and training activities of the RCE and make them available to qualified investigators from academia, biotechnology companies, the pharmaceutical industry, and other appropriate entities in the geographic region; 4) develop translational research capacity for testing and validating vaccine, therapeutic and diagnostic concepts for biodefense and emerging infectious diseases; and 5) be prepared and available to provide facilities and scientific support to first-line responders in the event of a national biodefense emergency. The scope of acceptable areas of investigation includes research ranging from basic, to the basic/clinical interface, to clinical investigations, spanning the range of studies needed to establish a comprehensive national program for the NIAID Category A-C agents. While small proof-of-concept Phase I or Phase I/II clinical trials are encouraged, large Phase II or III clinical studies are beyond the scope of this program and will not be supported. A list of research areas that are considered relevant for the purposes of this RFA follows. This list is not all-inclusive, and prospective applicants are encouraged to discuss program relevance issues with NIAID program staff listed under INQUIRIES. At this time, studies on Bacillus anthracis and orthopox viruses are well represented within the NIAID research portfolio, and investigators are encouraged to focus on other Category A agents and the Category B and C agents unless presenting novel concepts relating to B. anthracis and orthopoxviruses. Research areas relevant to this RFA: o Basic biology of less well studied Category A-C agents. o Mechanisms of pathogenesis, with emphasis on the less well studied agents. o Application of genomic and proteomic strategies. o Basic aspects of the innate and adaptive immune responses. o Rapid, sensitive, and specific approaches for agent detection and identification for use in a clinical setting. o Target identification for diagnostics, therapeutics, and vaccines, including assay development. o Development of new animal models for pathogenesis studies, for therapeutics and vaccine evaluation, and for rapid diagnostic studies. o Preclinical studies to facilitate translation of research findings into clinical interventions. o Testing through proof-of-concept Phase I or Phase I/II clinical trials of drugs, diagnostics and vaccines. For a more detailed list of the NIAID biodefense research priorities, applicants are encouraged to consult the strategic plan and research agendas (http://www.niaid.nih.gov/biodefense/research/strat_plan.htm) Minimum Requirements for the Research Plan 1. Background, Strategic Plan and Management of the RCE In this section, identify and describe the overall goals and objectives of the RCE, the organizational structure of the proposed Center, participating institutions/organizations, and the role of all consortium members. As part of the application preparation process, the consortium organizers must undertake the development of a strategic plan, and provide a chronological review of planning and priority- setting processes. The purpose of the strategic plan is to identify unique opportunities for the RCE to contribute to biodefense and emerging infectious diseases research, as well as identify unmet needs that may be addressed by the planned RCE resources. The plan must include both short- and long-term goals, and must include descriptions of objective milestones that will be used to measure progress. The following framework is suggested for developing the strategic plan: o Strengths - Identify and describe the strengths of the proposed consortium including a brief summary of the research and development experience and expertise of RCE participants as well as the current facilities and other research resources available. o Opportunities - Identify and evaluate the potential opportunities to establish high quality research, training and development programs using RCE funds. RCEs are encouraged to form associations with other federal agencies, such as: the Centers for Disease Control and Prevention (CDC), the Department of Defense, the U.S. Department of Agriculture (USDA), and the Department of Energy and the National Laboratories; with NIH intramural research laboratories; with state and local health departments; and with the private sector. As part of the planning process, the RCE leadership should: determine which collaborations with the institutions in their geographic region will be further developed; target opportunities that can utilize the unique strengths within the consortium; and target opportunities that will address the goals of the NIAID Biodefense Research Agenda. o Research Theme - The intent of the RCE Program is to support a substantial range of research, training and development activities that involve vibrant, multi-disciplinary approaches that transcend customary thinking and organizational structures to address critical questions related to the control of NIAID Category A-C Agents. The theme and the range of activities being pursued should be clearly defined as a result of the strategic planning process. o Action Plan - Outline the major biodefense and emerging infectious diseases studies to be assisted by RCE funding and describe how these research efforts will translate into vaccines, therapeutics and/or diagnostics for NIAID Category A- C agents. Choose the highest priority opportunities and develop a detailed research plan, with milestones, for the first year of funding and describe overall aims and milestones for subsequent years of funding. Elements of the action plan include: determining what research projects will be pursued and which cores will be established or expanded; identifying possible pilot projects for support as developmental research projects; defining milestones for specific products that the RCE proposes to pursue; establishing career development programs for new and existing faculty and research staff; establishing policies and procedures for access to and handling of NIAID Category A-C agents; and establishing overall policies and procedures for the management of cores and other Center resources. Specific thematic areas should emerge from the strategic planning process, and the action plan should elucidate how the RCE will capitalize on such programmatic themes. o Outcome Measurements - Determine and describe how progress on the action plan will be measured. Include qualitative and quantitative criteria for measuring how the RCE provides "added value" and for assessing the unique contributions of the Center that cannot be provided by other research awards. Define metrics for assessing long-term goals for the entire funding period, and specific, detailed milestones with timelines for the first year for each project and activity. o Emergency Response Plan Implementing an Emergency Response Plan is a responsibility within the Administrative Core and should be described in this section. While the emergency response plan may vary from Center to Center, it is expected that RCEs will: identify and establish communication lines with key biodefense contacts in regional states and large cities; define possible roles for the RCE in the event of a biodefense emergency in consultation with partners; identify the resources associated with the RCE that could contribute to efforts during an emergency; and educate Center researchers and other personnel about their role in this activity and about established response systems such as the CDC Laboratory Response Network and regional organizations. The RCEs are expected to perform activities that would complement public health efforts and responsibilities, as appropriate, not duplicate these well-defined and established roles. o Administrative Core - The Administrative Core director and staff are responsible for managing, coordinating, and supervising the entire range of Center activities, monitoring progress and ensuring that the strategic plan is implemented. A well-developed Administrative Core is integral to the Center’s success and should be clearly defined in the application. The Principal Investigator must be director of the Administrative Core and must commit at least 25% effort to these responsibilities, in addition to his/her own RCE research and other activities. The management plan should include: the structure and roles of Administrative Core personnel; who among the Center leadership team is responsible for each major RCE activity; how fiscal and other resources will be allocated and prioritized; how communications throughout the Center will be facilitated; and the structure and role of any major committees that will be instituted to help manage Center business. Organizational charts for the Administrative Core and the Center as a whole should be provided. The Administrative Core director and staff are responsible for ensuring that sure appropriate systems are in place to provide for biosafety and security of materials, data and facilities, including compliance with regard to select agent regulations. Institutions must be in compliance with U.S. laws and regulations and DHHS and NIH policies in effect at the time of grant award and during the period of performance of the research. The management plan for the RCE must include procedures for continually evaluating and selecting the most promising research, with the ultimate goal of developing clinically useful biodefense and emerging infectious diseases vaccines, therapeutics or diagnostics. It is expected that research projects with little translational potential will be discontinued and that new projects with greater potential will be initiated as the program evolves and matures. The support for attendance at NIAID Biodefense Network meetings can be provided through the award as part of the administrative core travel budget. 2. Research Program Each application must propose a Research Program that includes at least five (5) Research Projects, which together will enable the RCE to contribute significantly to the NIAID biodefense and emerging infectious diseases mission. The range of research topics that may be proposed is outlined above. A project may be similar in scope and design to a Research Project Grant (R01), or it may be more extensive and resemble a Program Project Grant (P01) and include more than one related research project with more than one investigator. Collectively, the projects should support the strategic plan and emphasize synergy and integration of overall themes. Centers are expected to focus on and incorporate into the research projects state-of-the- art technology and approaches. Each research project must include measurable milestones, with timelines, and criteria for assessing success/productivity at periodic intervals. Applicants are encouraged to carefully consider the scope and range of research proposed and develop a Research Program that is coherent overall and consistent with available resources and personnel. 3. Scientific Facilities Cores - The RCE plan must include development and maintenance of core resources/facilities that are essential for the Center's success. Cores may include resources that are currently available at the institution, as well as new or expanded ones. The cores must facilitate and add value to the research and training activities, as well as create new regional biodefense capacity. The role the cores will play in RCE activities and their value to the Center and the region must be clearly described. If existing facilities are to be provided with RCE funds, the added value to the Center must be clearly described and justified. A detailed plan for ensuring that core facilities can be accessed in a timely way by RCE investigators, other NIAID-funded investigators from outside the Center, and other qualified investigators in the region must be provided. Plans for staffing, managing, and prioritizing use of the cores must be provided, as well as plans for determining fees to users. In addition, cores must be available and integral to the RCE emergency response plan. A necessary component of the Center's success will be the availability of adequate access to BSL3/4 biocontainment facilities. Applicants must describe in detail their research and training plans that will require high level containment facilities, and in this component, provide a description of facilities that are available currently or planned at the consortium institutions. A table listing each activity that requires BSL3/4 access and the likely facilities to be used must be included. If plans and arrangements have been made at the time of application with other planned or existing biocontainment facilities, these should be described. 4. Developmental Research Plan Every RCE must identify and support Developmental Research Projects ( pilot projects) that take advantage of emergent technology and new research opportunities. These projects may involve scientists within the RCE or extend to appropriate regional scientists outside the Center. Key purposes of this RCE activity are expanding the scope and range of research, investigators, and institutions involved in biodefense and emerging infectious diseases research and allowing for testing of novel ideas (with little preliminary data) and new technologies. The Developmental Research Plan must describe processes for: soliciting applications for Developmental Research Projects from the region; selecting the most promising projects for funding, consistent with the strategic plan and the overall RCE Program goals; and monitoring success/productivity of the projects, including terminating or promoting them to full Research Project status. Some Developmental Research Projects will begin during the first year, while others will be phased in during the life of the award. The overall success of the RCE will, in part, be determined by the choice of Developmental Research Projects and their growth into new NIH investigator- initiated research grants to advance specific vaccines, therapeutics, diagnostics or basic science studies. While the specific number of Developmental Projects to be supported is at the discretion of the applicant, total funding for these projects may not exceed $600,000 direct costs in any one year, with no more than $100,000 for any one study. The plan for management of the funds associated with the developmental projects must be addressed in the application. These funds are intended to remain flexible and support studies lasting no more than two years. Applicants should not submit detailed descriptions of projects that would be supported by Developmental Research funds; these will be selected and approved after funding. The use of Developmental Research Projects permits maximal flexibility to advance in the directions that seem most scientifically fruitful; successful pilot projects may also mature and replace full Research Projects that are no longer contributing significantly to the objectives of the RCE. As a result, the scientific members of the RCE may change during the course of the award. 5. Career Development and Training Programs The RCE must include a consistent and significant commitment to career development and training, with the goal of increasing the availability of qualified researchers and other personnel for biodefense and furthering their career development. The training must be an integral part of the strategic plan, and complement the research activities. The RCE budget should support the salary and research costs of candidates with outstanding potential, as well as other reasonable costs for career development and training activities. Each application should include at least two (2) career development projects and it is recommended that one be focused on basic research and the other on translational/clinical activities; others may be added at the discretion of the consortium leadership. Career Development Projects for individuals may focus on advanced post- doctoral candidates, junior faculty, or established investigators who wish to develop or refocus their careers on biodefense and emerging infectious diseases research, as well as technical support staff. This may include mentored research experiences for current health professionals and faculty/staff interested in starting and pursuing research in the areas of biodefense and emerging infectious diseases. Each candidate must have a mentor and devote at least 80% of his/her effort to biodefense/emerging infectious diseases research. The description of these plans should include the policies, criteria, and processes for selecting candidates and monitoring their progress, including special efforts to recruit qualified women and minorities. Career Development Projects are not intended for pre-doctoral candidates. Other career development activities may be directed to groups of individuals; for example, there may be training programs for graduate students, technicians and others to learn specific skills, such as how to work in Biosafety Level (BSL) 3/4 areas or develop clinical research protocols. Other creative types of training are encouraged. If short-term training courses or similar activities are proposed, the application should describe the target audience, the curriculum, the faculty, and how participants will be recruited. Because Career Development Projects will generally be for less than two years in duration, studies which involve interventional clinical trials are not viewed as appropriate for the scope of this activity unless clearly associated with an on-going Research Project. Both types of career development projects should include plans for evaluating success and for following the impact of the training on the careers of the participating trainees. The NIAID supports a variety of training and career development opportunities, including various T, K, and F awards, and applicants are not to use the RCE to fund training that can be accomplished through other mechanisms. For additional information see NIH Guide Notice NOT-AI-03-046 - BIODEFENSE RESEARCH TRAINING AND CAREER DEVELOPMENT OPPORTUNITIES (http://grants.nih.gov/grants/guide/notice-files/NOT-AI-03-046.html). MECHANISM OF SUPPORT This RFA will use the NIH cooperative centers agreement (U54) award. Under this mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project; however, substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activities. Under a cooperative agreement, NIH staff is expected to support and stimulate the project by involvement in and otherwise working jointly with the award recipient as a partner. This interaction is further described under the section COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD. The U54 mechanism may support any part of a full range of research and development, from the very basic to early clinical activities. FUNDS AVAILABLE For Fiscal Year 2005, the NIAID intends to commit approximately $21 million to fund two (2) RCEs in response to this RFA. It is anticipated that awards will be made in the range of $8-12 million total costs per year. An applicant may request a project period of up to five years. Because the nature and scope of the proposed research will vary from application to application, the size and duration of each award may also vary. To ensure that research aims can be met and biohazards can be contained, an applicant may request up to $500,000 for significant alterations and renovations and/or up to $300,000 for major related equipment. Although current NIAID plans include support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of high scientific merit. ELIGIBLE INSTITUTIONS A consortium of investigators, at more than one institution, who are working together to pursue basic and applied research and development activities with a common theme that focuses on countering the threat of NIAID Category A-C agents, may apply. An application must contain several interactive research projects that constitute an interdisciplinary approach to the development of therapeutics, vaccines, or diagnostics for these agents. Applicant groups must be able to fully implement all of the required elements of an RCE. Applications that include participants from more than one region may be submitted. Foreign organizations are not eligible to serve as grantees and may not receive sub-contracts from domestic awards. Applicant organizations that may respond to this RFA include: o For-profit or non-profit organizations o Public or private research institutions, such as universities, colleges, hospitals, and laboratories INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, and resources necessary to carry out the required RCE activities is invited to form a consortium as described above, and 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. An NIH intramural scientist (IMS) may not serve as the Principal Investigator but may participate as a member researcher of the RCE. The participation of an IMS is independent of and unrelated to the responsibilities of the NIAID Program Staff as described below. An IMS who is one of the Center's member scientists will have the same programmatic rights and responsibilities as other investigators. SPECIAL REQUIREMENTS Consortium Plan In order to promote discussion and early consensus among the applicants regarding intellectual property (IP) and management matters that may arise during RCE consortium projects, the applicants are required to submit a consortium plan within six (6) months of the receipt of an award, and this requirement will be a term of award. While the specific terms of such a plan are left to the parties involved, NIAID recommends that the applicants consider the following points in the plan: o Measures to ensure the rapid utilization of inventions to benefit the public health through, inter alia, diligence in seeking patent protection for and licensing of new inventions when appropriate and the timely publication of research results. o Access by the RCE consortium participants to each others pre-existing IP rights to background technology (inventions, know-how, materials, information) required for performing RCE consortium projects -through, for example, non-assertion clauses or cross-licenses. o Timely reporting to the NIH of U.S. Government-funded inventions in accordance with the Bayh-Dole Act, 35 U.S.C. 202, and the coordination of patent filing, patent licensing and IP management for these inventions (including addressing their use by other RCE consortium participants if necessary for performing the RCE consortium projects). o Ownership and management of inventions to include items such as assignment of IP rights to employers, recognition of controlling U.S. law for U.S. Government-funded inventions and, for joint inventions, agreements that address licensing strategy and royalty sharing. o Exclusive/non-exclusive licensing option for commercial RCE consortium participants. o Notice of rights retained by the U.S. Government in inventions arising from federally funded RCE consortium projects. o Publication reporting and confidentiality to promote the preservation of patent filing rights. o Other technology transfer activities among the various RCE consortium participants, including but not limited to transfers of biological materials and other tangibles. o Disposition of IP rights and tangible materials at the expiration/termination of the RCE consortium and also upon the early departure of RCE consortium participants. o Sharing of research reagents and research tools for research purposes among RCE consortium participants and with other parties in accordance with the NIH Principles and Guidelines on Biomedical Research Resources (http://www.ott.nih.gov/policy/rt_guide_final.html). o Coordination of IP/technology transfer matters between the technology transfer/legal offices and the grants/contracts/sponsored research offices of academic/non-profit RCE consortium participants. o Overall RCE consortium management and, for major RCE consortium projects that will utilize IP, tangible property and other resources of the RCE’s commercial participants (e.g., proprietary materials, trade secrets and other confidential information, personnel, budget, facilities/equipment, etc.), a management scheme that encourages the participation of those commercial participants. o A mechanism for resolving disputes among the RCE consortium participants. o Terms for the potential addition and departure of RCE consortium participants. o Legal liability of the RCE consortium participants. Select Agents All awardee institutions must confirm that they are in compliance with Select Agent regulations (http://www.cdc.gov/od/sap) and NIH Guidelines for Research Involving Recombinant DNA Molecules (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html) to receive funding from NIAID. See also TERMS AND CONDITIONS OF AWARD. Meetings One determinant of success of the NIAID Biodefense Network will be the degree of communication among the participants. As such, the NIAID Biodefense Network will meet twice yearly or as needed in the event of a bioterrorism emergency event. The purpose of these meetings is to: share scientific information; assess scientific progress; identify new research and development opportunities and potential avenues of collaborations such as those with industry, private foundations, NIH intramural scientists, and other federal government agencies; and establish priorities that will accelerate the translation of preclinical findings into clinical applications, reallocate resources and conduct other business of the RCE Program. RCE Principal Investigators must attend and participate as voting members in the regular meetings and teleconferences to discuss progress and directions of research and to ensure that overall Program goals are being met. The support for attendance at NIAID Biodefense Network meetings can be provided through the award as part of the administrative core travel budget. Principal Investigators must coordinate and participate in regular, local meetings of the RCE to discuss progress and directions of center activities and to ensure that the necessary interdisciplinary interactions are taking place. Principal Investigators and appropriate other RCE investigators must attend an RCE Program Annual Scientific Meeting to be organized by the Network and participate in Network teams to advance RCE Program business. NIH Intramural Scientist Involvement A collaborating NIH intramural scientist (IMS) may not receive salary, equipment, supplies, or other remuneration from this award. The IMS must obtain written approval of his/her Institute’s Scientific Director to allocate resources to the project. The letter of approval must specify that no more than $600,000 direct costs of intramural resources will be allocated to the project and provide assurance that the conduct of the project will comply with the DHHS regulations for research involving human subjects (if applicable) and with the PHS policy for vertebrate animal research, as well as other pertinent matters such as select agents. COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD The administrative and funding instrument used for this program is a cooperative centers agreement (U54), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and programmatic involvement with the awardee is anticipated during the grant award. Cooperative agreements are subject to the same administrative requirements as grants. The following Terms and Conditions of Award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations in 45 CFR Part 74 and 92 and administered under the NIH Grants Policy Statement. 1. Clinical Terms of Award When clinical studies or trials are a component of the research proposed, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. An Updated NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. 2. Awardee Rights and Responsibilities Awardees will have primary responsibility for the project as a whole, including research design and conduct, data collection, data quality control, data analysis and interpretation and preparation of publications, as well as collaborations with other awardees. Awardees will retain primary custody of and have primary rights to the data developed under these awards, subject to government rights of access consistent with current HHS, PHS, and NIH policies. However, awardees must be committed to making the therapeutics, vaccines, diagnostic products, other research tools, and research materials they develop available to the biodefense and emerging infectious disease research community through the NIAID Biodefense and Emerging Infections Research Resources Repository (http://www.beiresources.org). Principal Investigators must coordinate and participate in regular, local meetings of the RCE to discuss progress and directions of center activities and to ensure that the necessary interdisciplinary interactions are taking place. Principal Investigators and appropriate other RCE investigators must attend an RCE Program Annual Scientific Meeting to be organized by the Network and participate in Network teams to advance RCE Program business. RCE Principal Investigators must attend and participate as voting members in the regular meetings and teleconferences of the NIAID Biodefense Network to discuss progress and directions of research and to ensure that overall Program goals are being met. An awardee is required to submit a consortium plan regarding intellectual property (IP) and management matters that may arise during RCE consortium projects within six (6) months of the receipt of an award, for NIAID approval. Awardees agree to participate in projects identified by the NIAID Biodefense Network that include common research interests that address a specific problem or threat. Awardees will submit annual progress reports to the NIAID that describe activities and accomplishments during the previous funding/reporting period. Awardees must ensure that the core facilities of the RCE are utilized to the fullest extent possible and that procedures remain in place to make core facilities available to qualified users in the region from outside the RCE. Awardees who conduct research involving Select Agents (see 42 CFR 73 for the Select Agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and plant pathogens) must complete registration with CDC (or USDA, depending on the agent) before using NIH funds. No funds can be used for research involving Select Agents if the final registration certificate is denied. 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: (http://ott.od.nih.gov). An NIH intramural scientist (IMS) may participate as a member researcher of the RCE. The participation of an IMS is independent of and unrelated to the responsibilities of the NIAID Program Staff as described below. An IMS who is one of the Center's member scientists will have the same programmatic rights and responsibilities as other investigators. 3. NIAID Program Staff Responsibilities The role of RCE Program Staff Scientist in the cooperative agreement is to support and encourage the recipient's activities by substantial involvement above and beyond normal program stewardship as facilitators in the process without assuming responsibilities that remain with the PI. The RCE Program Staff Scientist from the NIAID Division of Microbiology and Infectious Diseases assigned to each RCE will work closely with the PI and other RCE member scientists to facilitate collaborations with other NIAID-funded research groups and to leverage the resources available to the Program. Other NIAID staff will be responsible for normal program stewardship and monitoring of award. The NIAID Program Staff Scientist will monitor the progress of the RCE, assisting in the coordination of research approaches among Centers, and contributing to the fine-tuning of research projects or approaches as warranted. The NIAID Program Staff Scientist will support and facilitate this process but not direct it, and will also provide assistance with all major transitional changes of an individual RCE's activities prior to implementation to assure consistency with the overall goals of the RCE Program and the NIAID biodefense mission. When necessary, issues may be brought to the NIAID Biodefense Network for discussion. The NIAID Program Staff Scientist will keep the RCEs informed about other ongoing studies supported by NIAID to avoid duplication of effort and encourage sharing/collaboration in the development of new clinically useful reagents and methodologies for biodefense and emerging infectious diseases research. The NIAID Program Staff Scientist will coordinate access for the RCE to other NIAID resources as well as assist the research efforts of the RCEs by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies. The NIAID Program Staff Scientist may assist, where warranted, in data analyses and interpretation, and the dissemination of study findings to the research community and health care recipients, including co-authorship of the publication of results of studies conducted by the RCEs, subject to NIH publication policies. 4. Collaborative Responsibilities The NIAID Biodefense Network will provide overall scientific coordination of the RCE Program. RCE Principal Investigators, National Biocontainment Laboratory and Regional Biocontainment Laboratory Principal Investigators, and the overall NIAID RCE Program Director will be voting members. Additional NIAID Program Staff and scientists other than PIs may participate as non-voting members. The NIAID Biodefense Network may determine the need to redirect certain RCE efforts when results and data suggest that the proposed research is no longer feasible or progressing toward desired goals. Some RCEs will develop common research interests; research focus groups may be formed to pursue coordinated research activities identified by the NIAID Biodefense Network, and the Network may 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 also provide a forum for coordinating RCE activities that require a liaison function with other federal agencies such as the Food and Drug Administration, USDA, and CDC. 5. Arbitration When agreement between an awardee and NIAID staff about scientific/programmatic issues that may arise after the award cannot be reached, an arbitration panel will be formed. The panel will consist of one person selected by the awardee, one person selected by NIAID staff, and a third person selected by the two. The decision of the arbitration panel, by majority vote, will be binding. This special arbitration procedure in no way affects the right of an awardee to appeal an adverse action in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations 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 Written and telephone inquiries from potential applicants to answer questions or clarify any issues about the RCE Program and this RFA are welcome. Applicants are strongly encouraged to discuss their plans with NIAID Program Staff to determine suitability. Inquiries may fall into three areas: programmatic, peer review, and financial or grants management issues. Direct inquiries regarding programmatic issues to: Rona Hirschberg, Ph.D. (rh199i@nih.gov) Alicia Dombroski, Ph.D. (ad211y@nih.gov) Susan Garges, Ph.D. (sg9g@nih.gov) Michael Hevey, Ph.D. (mh484c@nih.gov) RCE Program Division of Microbiology and Infectious Diseases National Institute of Allergy and Infections Diseases Room 5007, MSC-6603 6610 Rockledge Drive Bethesda, MD 20892-6603 Telephone (301) 402-4197 Fax: (301) 480-1263 Direct inquiries regarding peer review issues to: Katherine White Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room Number 3131, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: 301-435-1615 FAX: 301-402-2638 Email: kw174b@nih.gov Direct inquiries regarding financial or grants management matters to: Lesia Norwood Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room Number 2117, MSC-7614 6700-B Rockledge Drive Bethesda, MD 20892-7614 Telephone: 301-402-7146 FAX: 301-493-0597 Email: ln5t@nih.gov LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Descriptive title of the proposed research o Name, address, telephone number and e-mail address of the Principal Investigator o Names of other key personnel o Names of Institution(s) participating in the RCE application 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 subsequent applications, the information that it contains allows NIAID staff to estimate the potential review workload and plan the review. The letter of intent must be received by August 9, 2004. The letter of intent should be sent to: Katherine White Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room Number 3131, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: 301-435-1615 FAX: 301-402-2638 Email: kw174b@nih.gov SUBMITTING AN APPLICATION Applicants for U54 grants must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). 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 http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. The PHS 398 document is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. SUPPLEMENTARY INSTRUCTIONS The application should be assembled in this order: PHS 398 Face page PHS 398 Form Page 2 for the entire application List of all participating institutions and key investigators/personnel at each Overall table of contents Summary budget (chart) for the entire center PHS 398 Form Page 5 Biographical sketch of PI Research plan - Must have the following five sections - Note that face pages, biographical sketches, budget pages, literature citations, letters of support, checklists and other form pages are excluded from the page limits below. 1. Background, Strategic Plan, and Management of the RCE May not exceed 50 pages; this component will be weighted 30% in the overall score. a. Introduction, to include: o Overall goals of the RCE o Chronological review of planning and priority setting processes o Letter(s) of commitment from participating institutions (these letters of commitment do not count against the page limit) b. Strategic Plan, to include: o Strengths o Opportunities o Research Theme o Action Plan o Outcome Measures o Emergency Response Plan c. Administrative Core, to include: o Face page o PHS 398 Form page 2 o Biographical sketches o Budget, using PHS 398 Form Pages 4 and 5, and budget justification o Discussion of the Administrative Core 2. Research Program - Each application must include at least five single- or multi-project Research Projects. Each single-project (RO1 type) Research Project has a 25 page limit [sections A-D as defined in the PHS 398 instructions] and each multi-project (PO1 type) Research Project has a 35 page limit, with a maximum of 175 pages total for the Research Program, regardless of the number or complexity of the Research Projects. The inclusion of experimental procedures within the human subjects or vertebrate animal sections of the application, or in the appendix to circumvent page limits is not allowed. Components 2 (Research Program) and 3 (Scientific Facilities Cores) will together be weighted 50% in the overall score. For each single-project Research Project include: o Face page o PHS 398 Form Page 2 o Budget pages (PHS 398 Form Pages 4 and 5) and budget justification o Biographical sketches o Sections A-D o Human subjects o Vertebrate animals o Literature cited o Checklist For each multi-project Research Project include: o Introduction to the entire multi-project (text counts toward page limits, literature cited does not) o All budgets and budget justifications for the project (form pages 4 and 5 for each subproject, clearly labeled as to sub-project, and a summary table for the overall project) o For each subproject include o Face page o PHS 398 Form Page 2 o Biographical sketches o Section A-D o Human subjects o Vertebrate animals o Literature cited o All checklists, clearly labeled as to subproject 3. Scientific Facilities Cores May not exceed 10 pages each [sections A-D as defined in the PHS 398 instructions], with a maximum of 70 pages total. Components 2 (Research Program) and 3 (Scientific Facilities Cores) will together be weighted 50% in the overall score. For each Scientific Core include: o Face page o PHS 398 Form Page 2 o Biographical sketches o Budget, using PHS 398 Form Pages 4 and 5 and budget justification o Description of the Core and its operations, and justification o Human subjects o Vertebrate animals o Checklist 4. Developmental Research Plan - May not exceed 10 pages [sections A-D as defined in the PHS 398 instructions]; this component will be weighted 10% in the overall score. Developmental Research Plan must include: o Face page o Biographical sketches o Description of the plan for conducting the Developmental Research activities o Budget, using PHS 398 Form pages 4 and 5 (with amounts requested under Other Expenses) and budget justification 5. Career Development and Training Program May not exceed 10 pages per project [sections A-D as defined in the PHS 398 instructions], with a maximum of 30 pages total for all Career Development Projects; this component will be weighted 10% in the overall score. For each project include: o Face page o PHS Form page 2 o Budget, using PHS 398 Form Pages 4 and 5, and budget justification o Biographical sketches o Description of project o Human subjects o Vertebrate animals o Literature cited o Checklist Checklist for the entire application. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/01) 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: http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 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 (20817 for Express Service) At the time of submission, two additional copies and all five copies of appendix material for the application must also be sent to: Katherine White Division of Extramural Activities National Institute of Allergy and Infectious Diseases Room Number 3131, MSC-7616 6700-B Rockledge Drive Bethesda, MD 20892-7616 Telephone: 301-435-1615 FAX: 301-402-2638 Email: kw174b@nih.gov Applications that are not received as a single package on or before the September 9, 2004 or that do not conform to the instructions contained in PHS 398 (rev. 5/01) Application Kit (as modified in, and superseded by, the NIAID BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS"), will be judged non-responsive and will be returned to the applicant. Investigators wishing to participate in a multi-project grant must be aware of this policy before making a commitment to the Principal Investigator and awarding institution. It is highly recommended that the appropriate NIAID program contact be consulted before submitting the letter of intent and during the early stages of preparation of the application. (See program contact under INQUIRIES). SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA: Applicants for U54 cooperative agreements must follow special application guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS; this brochure is available from NIAID listed under INQUIRIES via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm. This brochure presents specific instructions for sections of the PHS 398 (rev. 5/01) application form that should be completed differently than usual. For all other items in the application, follow the usual instructions in the PHS 398. APPLICATION PROCESSING: Applications must be received on or before the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. Only new applications will be accepted for this RFA. Applications must meet all eligibility requirements as described above and must address all programmatic requirements (see SPECIAL REQUIREMENTS above) in the RFA. APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES WILL NO LONGER BE ACCEPTED. This policy does not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) (http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html) This change in practice is effective immediately. This policy is similar to and consistent with the policy for applications addressed to Centers for Scientific Review as published in the NIH Guide Notice http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. 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 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. Depending on the total number and research topics of applications received in response to this RFA, applications may be separated into subgroups for review by different peer review committees. 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 will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the National Institute Allergy and Infectious Diseases Advisory Board The NIH reserves the right to conduct site visits or reverse site visits when deemed essential. REVIEW CRITERIA The general review criteria for U54 multi-project cooperative agreement applications are presented in the NIAID brochure entitled "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS at http://www.niaid.nih.gov/ncn/grants/multibron.htm. 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: Overall Evaluation and Scoring The overall application score will be based on review and merit of the individual components as well as the merit of the application taken as a whole. A single numerical priority score will be assigned to the whole application after consideration of all of the elements listed below. The Background, Strategic Plan and Management of the RCE, the individual Research Projects and the Research Program as a whole; the Career Development plan as a whole; and the Developmental Research Projects plan as a whole will be assigned numerical priority scores. The Scientific Facilities Cores will be scored using qualitative descriptors. Each of the scores will contribute to the final overall score with the following weights given to the various components: Research Program and Scientific Facilities Cores combined, 50%; Introduction, Strategic Plan and Management of the RCE, 30%; Career Development program, 10%; and Developmental Research plan, 10%. The overall score for the application will be based on the scientific merit of the individual components as well as the overall synergy and integration of the components, the effectiveness and adequacy of plans for sharing resources, the overall program organization and capability of the associated personnel, and the extent to which having a RCE would contribute to the global NIAID biodefense mission and achieve wide geographical distribution of Centers. Criteria and Attributes to Consider for Evaluation of Application Components: Background, Strategic Plan, and Management of the RCE o Feasibility, innovation and scientific/technical merit of the proposed goals of the RCE as well as the plans to achieve those goals. o Potential for the proposed RCE to develop critical, new knowledge about biodefense and emerging infectious diseases, and to enhance regional research and development capabilities. o Feasibility of the proposed research to span basic as well as translational/clinical issues and potential for the proposed research goals to lead to vaccines, diagnostics and therapeutics for NIAID Category A-C agents. o Strength, merit and feasibility of plans to promote synergistic interactions among the participants of the proposed Center. o Strength, merit and feasibility of plans for Center interactions with federal, state and local agencies or with industrial partners; and for rapid and effective communication among the proposed participants and with the broader constituency of the Center. o Scientific/technical merit and feasibility of the proposed milestones, and appropriateness and feasibility of the proposed metrics to quantify and ascertain productivity. o Appropriateness and feasibility of plans to incorporate research projects and/or cores in response to emerging opportunities or to eliminate unproductive projects and/or cores. o Merit and appropriateness of the documented institutional support for the goals of the Center, including the commitment of additional resources. o Strength, merit and feasibility of documented plans to leverage additional scientific and technical resources to increase the impact of NIAID funds. o Merit and feasibility of the documented capability and interest of the proposed institution(s) to serve as a regional biodefense first responder. o Appropriateness and feasibility of plans to rapidly develop the Center. o Adequacy of the training, experience, level of commitment, availability and qualifications of the Principal Investigator and key personnel of the leadership team to successfully lead and manage the proposed Center. o Appropriateness and clarity of the organizational structure and other plans for managing the Center's activities for prioritization of competing needs. o Appropriateness and clarity of the administrative structure and lines of authority as well as plans for alternate lines of authority in the Principal Investigator's absence. o Appropriateness of plans to make the Center and its resources available to investigators and institutions throughout the region. o Appropriateness of the management plan for fiscal accountability and communications within the Center. Research Program The following review criteria for research projects will be applied to each project in the context of how the project supports the strategic plan and advances the overall goals of the Center. o Significance - Relevance of the research proposed for advancing the biodefense mission of the NIAID, contributing to the RCE strategic plan, and inclusion of an appropriate representation of NIAID Category A-C agents. o Approach - Appropriateness of the conceptual framework, design, methods, and analyses for the aims of the project and the RCE program. An effective strategy for selecting approaches and technologies within the RCE to address the research questions should be evident. Where appropriate, investigators should include approaches that will translate into safe, feasible and useful therapeutics, vaccines, and diagnostics. o Innovation - Novelty of concepts, approaches and methods. Project leaders should seek to advance, extend or challenge existing paradigms, or develop new methodologies or technologies relevant to biodefense. However, some significant and important studies may not be inherently innovative, and this should be considered when evaluating this criterion. o Investigator - Appropriateness of the training, qualifications, experience, and accomplishments of the project leader which relate to the ability to accomplish the proposed project. The project leader is expected to allocate sufficient effort to RCE activities. The application should provide documentation that the project leaders have the aptitude and volition to function as part of an integrated team. o Environment - Adequacy of the accessibility of personnel at the institution(s) who are experienced with NIAID Category A-C Agents consistent with the proposed research. Adequate, appropriate facilities must be available. For projects that include translational and clinical studies, there should be adequate support and expertise available for the successful pursuit of the proposed work. Projects should include a plan to take advantage of Center resources and for inclusion of the project into Center activities. o Clinical Studies - Because one of the goals of the RCE program is to discover and develop products for human use, the necessity for research involving human subjects or clinical materials is obvious. However, careful consideration should be given to the appropriateness and scope of projects which involve clinical studies. While small proof-of-concept Phase I or Phase I/II clinical trials are appropriate, large Phase II or III clinical studies are beyond the scope of this research program. Multi-project Research Projects will be further evaluated for cohesiveness, the suitability of plans for collaboration and exchange of ideas among participants, and for evidence that program components will bring synergy and added value to overall Center activities. Scientific Facilities Cores o Appropriateness of the proposed core facilities in the context of the overall strategic plan and the proposed research and training activities. o Feasibility and clarity of plans for prioritizing the use of facilities, for allocating availability to the proposed research projects, and for ensuring that the core facilities are used to the fullest extent including access by non-RCE investigators and institutions. o Qualifications, experience and commitment of key personnel for running the core facilities. o Documented merit of the core proposed in the context of existing facilities in the Center and region. o Adequacy and feasibility of plans to ensure that during a time of National biodefense emergency the cores will re-align their activities to assist in the local response through research activities. o Appropriateness of the schedule of user fees set to ensure broad accessibility and utilization by regional partners, particularly those with limited resources. o Clarity of the need for BSL3/4 facilities. o Adequacy and feasibility of plans to establish linkages to existing BSL3/4 facilities. o Collective experience of Center participants in the operation of biocontainment facilities and ability to provide training for use of any proposed biocontainment facilities. o Adequacy and feasibility of the phase in plans to provide a mechanism for research to proceed until new BSL3/4 capacity is on-line. Developmental Research Plan o Strength, feasibility and appropriateness of the proposed plan and criteria to select new developmental projects and monitor their long term success, including adequacy of the strategy for selecting projects that leverage resources and complement the Center's strengths. o Inclusiveness and feasibility of the developmental project plan for bringing new investigators into the biodefense research area, and recruitment strategies to ensure a broad pool of applicants and scientific topics for the development projects. o Adequacy of the proposed procedures and criteria for the phase-in and phase-out of developmental projects and for the advancement of promising developmental projects to full Research Project status. Career Development Program o Quality and appropriateness of the technical and scientific expertise, mentoring experience, and availability of the faculty and staff to conduct the proposed training. o Strength of the documented available training infrastructure such as laboratories, clinics, etc. o Merit, feasibility and level of creativity of the proposed approaches to increase the human resources available for biodefense including recruitment of sufficient qualified students and trainees, and adequacy of plans for the inclusion of women and minorities. o Relevance of the proposed training to, and integration with, the goals of the strategic plan. o Appropriateness of the proposed training in relation to the current education framework of the involved institution(s). o Potential contribution of the specific training proposed to the overall RCE mission. o Suitability of plans for evaluation of the training and documenting success. ADDITIONAL REVIEW CRITERIA: The Research Program, the Developmental Research plan, the Career Development Program, and the application as a whole will be evaluated with respect to the following: 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: August 9, 2004 Application Receipt Date: September 9, 2004 Peer Review: December, 2004 Earliest Anticipated Award Date: April, 2005 AWARD CRITERIA If multiple applications from a single region are reviewed and scored, the NIAID reserves the right to negotiate the merging of the two into a single RCE. This will be done based upon the peer review-identified strengths and weaknesses of each application, and programmatic need. NIAID may also negotiate prior to award to modify the scope of the proposed research and other activities to meet overall program needs. In addition to Scientific Merit, other criteria that will be used to make award decisions include: o Availability of funds o Programmatic priorities o Coverage of desired research scope o Regional distribution of meritorious applications REQUIRED FEDERAL CITATIONS HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for all types of clinical trials, including physiologic, toxicity, and dose- finding studies (phase I); efficacy studies (phase II), efficacy, effectiveness and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible. http://grants.nih.gov/grants/policy/data_sharing Investigators should seek guidance from their institutions, on issues related to institutional policies, local IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score. INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the AMENDMENT "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects that is available at http://grants.nih.gov/grants/funding/children/children.htm REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH policy requires education on the protection of human subject participants for all investigators submitting NIH proposals for research involving human subjects. This policy announcement is in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s)for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review. PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this 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. STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The Department of Health and Human Services (DHHS) issued final modification to the Standards for Privacy of Individually Identifiable Health Information , the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR). Those who must comply with the Privacy Rule (classified under the Rule as covered entities ) must do so by April 14, 2003 (with the exception of small health plans which have an extra year to comply). Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on Am I a covered entity? Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html. 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 Catalogue of Federal Domestic Assistance at http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, Allergy, and Transplantation Research and No. 93.856, Microbiology and Infectious Diseases Research. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The NIH Grants Policy Statement is available at http://grants.nih.gov/grants/policy/policy.htm. 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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