REGIONAL CENTERS OF EXCELLENCE FOR BIODEFENSE AND EMERGING INFECTIOUS DISEASES RESEARCH (RCE) RELEASE DATE: August 1, 2002 (see amendment NOT-AI-02-051) RFA: AI-02-031 National Institute of Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov) LETTER OF INTENT RECEIPT DATE: November 15, 2002 APPLICATION RECEIPT DATE: January 15, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Letter of Intent o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE The National Institute of Allergy and Infectious Diseases (NIAID) invites applications (U54) for funds to develop Regional Centers of Excellence (RCE) in areas related to Biodefense and Emerging Infectious Diseases Research (see page 9 for regions). The NIAID will also be releasing another RFA for P- RCE Planning Grants (U56) soon. This program will provide funds for start up and developmental activities that will lead to RCE applications. The overall goal of the RCE Program is to develop and maintain strong infrastructure and multifaceted research and development activities that will provide the scientific information and translational research capacity to make the next generation of therapeutics, vaccines and diagnostics against the CDC Category A-C Agents (http://www.bt.cdc.gov/agent/agentlist.asp#catagoryadiseases), with particular emphasis on Category A. To accomplish this goal, the Centers will be provided with support 1) to develop and conduct programs of investigator-directed research, 2) to train researchers and other personnel for biodefense research activities, 3) to develop and maintain comprehensive core facilities to support the research and training activities of the RCE, 4) to develop translational research capacity for testing and validating vaccine, therapeutic and diagnostic concepts for biodefense and emerging infectious diseases, 5) to maintain and make available core facilities and other support to approved investigators from academia, biotech companies, the pharmaceutical industry, and other appropriate entities in the region for the purpose of performing basic research and for testing and evaluating vaccines, therapeutics and diagnostics for CDC Category A-C Agents, 6) to be ready 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 applications for programs to address the fundamental research and development questions that will provide the information needed to counter the threat of bio-terrorism. Diverse research and development approaches are encouraged, as long as they include the following essential features: a biodefense research focus on CDC Category A-C Agents, particularly Category A, which incorporates a translational component with the long term goal of developing testable products. Additionally, the consortium must document: institutional commitment, organizational capabilities, ability to develop and expand facilities, plans for training of new investigators and other participants in the national biodefense effort, and interdisciplinary coordination and collaboration, particularly linkages to federal, state, and local agencies. The consortium 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 research, is required to lead the research thrust which underlies all the other activities of the RCE. In addition, the RCE should designate specific platforms and technologies that will serve as the basis for the Center"s development programs. Platforms are cross-cutting technologies or experimental approaches that integrate the research and development activities. Examples of platforms include: genomics, proteomics, animal models, pre-clinical development, but others are welcome. The overall direction and scope of activities of the RCE Program and its participant Center sites will be centrally coordinated and monitored by a Management and Oversight Committee that is run through the RCE Program Office at NIAID to ensure that the RCE program contributes maximally and effectively to the biodefense and emerging infectious diseases effort. PUBLIC BRIEFING DATE: August 8, 2002 An informational session for investigators representing groups planning to submit applications in response to this RFA will be held August 8, 2002 at the Marriott Washingtonian Center Hotel in Gaithersburg, MD. Representatives from the NIAID extramural research programs and Division of Extramural Activities will be available to provide information and to answer questions relevant to preparing applications in response to this RFA. Questions and Answers from discussions at the meeting will be available on the NIAID website for those unable to attend. RESEARCH OBJECTIVES Background As identified by the recently convened NIAID Blue Ribbon Panel on Bioterrorism and Its Implications for Biomedical Research, there is a critical need for the establishment of highly developed research and development infrastructure with strong translational research capacity to implement the Biodefense Research Agenda of NIAID (http://www.niaid.nih.gov/dmid/bioterrorism/). To facilitate this initiative, the NIAID is establishing The Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) Program. Each Center will serve a geographical region and will be comprised of investigators at one or more participating universities and/or research institutions. The overall activity of the Centers will be research in support of the NIAID Biodefense and Emerging Infectious Diseases mission. The center member researchers will be encouraged to collaborate with other NIH-funded investigators within and outside the Center region. In addition, the Center will serve as a focal point to organize and promote linkages with pharmaceutical and biotech companies, with federal, state, and local agencies and with 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 national biodefense emergency the RCEs will rapidly realign their activities to assist local response efforts within their region. This includes making the their core facilities and other resources available to assist in the implementation of biodefense plans. Objective and Scope This initiative supports the establishment of Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE). The program is established for the purpose of developing and maintaining research and development capacity that is needed to evaluate and counter bioterrorism or emerging infectious disease events. To accomplish this the Centers will receive support to: 1) to develop and conduct programs of investigator- directed research, 2) to train researchers and other personnel for biodefense activities, 3) to develop and maintain comprehensive core facilities to support the research and training activities of the RCE, 4) to develop translational research capacity for testing and validating vaccine, therapeutic and diagnostic concepts for biodefense and emerging infectious diseases, 5) to maintain and make available core facilities and other support to qualified investigators from academia, biotech companies, the pharmaceutical industry, and other appropriate entities in the region for the purpose of performing basic research and for testing and evaluating vaccines, therapeutics and diagnostics for CDC Category A-C Agents, 6) to be ready and available to provide facilities and scientific support to first-line responders in the event of a national biodefense emergency. A list of research areas that are considered relevant for this U54 RFA follows. This list is not all-inclusive, and prospective applicants are encouraged to discuss program relevance issues with program staff cited under INQUIRIES. The scope of acceptable areas includes research from basic, to the basic/clinical interface, to clinical, spanning the range of inquiry needed to establish a comprehensive national program for these agents: The following are examples of research within the scope of the RCE program. For a more detailed list of NIAID Biodefense research priorities applicants are encouraged to consult the strategic plan. Basic biology of category A-C agents, with particular emphasis on category A Mechanisms of pathogenesis of A-C agents Application of genomic and proteomic strategies to category A-C agents Basic aspects of the innate and adaptive immune responses to category A-C agents Rapid, sensitive, and specific approaches for detection and identification of category A-C agents Target identification for diagnostics, therapeutics, and vaccines, including assay development Development of new animal models for pathogenesis studies, for therapeutics and vaccine evaluation, and for rapid diagnostic studies. Testing through Phase I clinical trials of drugs, diagnostics and vaccines. Strategic Plan As part of the preparing an application, the consortium organizers should undertake the following planning process, and document the steps taken in the application. The purpose of the strategic plan is to identify the significant opportunities and needs within our current knowledge base and in the resources currently available to the consortium that can be addressed by having a RCE. The plan should include both short and long term goals, and must include descriptions of objective milestones that will be used to measure success or failure. The following process framework is suggested for developing the strategic plan: 1) 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 resources available. Outline the major biodefense studies to be assisted by RCE funding and describe how these research efforts will translate into vaccines, therapeutics and/or diagnostics for CDC Category A- C Agents. 2) Opportunities - Identify and evaluate the potential opportunities to establish high quality research, training and development programs using RCE funds. The NIAID strongly encourages the RCE to form associations with other federal agencies, such as intramural NIH, CDC, DoD, Dept of Agriculture, DOE National Laboratories, and state and local health departments. As part of the planning process the RCE leadership should determine which collaborations with the institutions in their region will be further developed and target opportunities that can utilize the unique strengths within the consortium and that will also address the goals of the NIAID Biodefense Research Agenda. 3) Action Plan - Choose the highest priority opportunities and develop a detailed plan for the first year of funding and broader goals for subsequent years of funding. Elements of an action plan include determining what research projects will be pursued and which cores will be established or expanded, identifying possible projects for support as developmental projects, defining development goals for specific products that the RCE decides to pursue, establishing career development plans for new and existing faculty and staff by the consortium, establishing policies and procedures for access to and handling of CDC Category A-C Agents, establishing overall policies and procedures for management of cores and Center resources. Specific thematic areas will probably emerge from this strategic planning process, and the action plan should capitalize on such programmatic themes. 4) Outcome Measurements - Determine how progress on action plans 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 measures for assessing long-term goals for the entire funding period, and specific, detailed milestones for the first year. 5) Emergency Response Plan- Determine who the partners and contacts are in the case of a local, regional or national biodefense crisis. This should include an evaluation of the potential partners, and establishment of a plan to define a regional research role for the P-RCE to assist in the response. Application/Center Organizational Structure An application that includes the following elements is required: 1. Overall Research Theme The intent of the RCE Program is to support any substantial range of research, training and development activities as long as the plan involves vibrant, multi-disciplinary approaches that transcend customary thinking and organizational structures to address critical questions related to the CDC Category A-C Agents from very basic to clinical. The theme and the range of activities being pursued should be clearly defined as a result of the strategic planning process. 2. Research Projects Each application must include at least five Research Projects, which together will enable the RCE to contribute substantially to the NIAID biodefense mission. The range of research that may be proposed is outlined above. A significant amount of work on category A agents is an essential component of the research plan. A project may be similar in scope and design to an R01 application, or it may be more extensive and resemble a P01. Each application must highlight research platforms representing cross-cutting approaches that will be integrated throughout the Research Projects and integrate them. Examples of platforms are: animal models, immune response, proteomics, and genomics, how the platforms apply to the individual Research Projects must be clearly described. 3. Career Development Projects The RCE must include a consistent and significant commitment to career development with the goal of increasing the availability of researchers for biodefense. This may focus on advanced post-doctoral candidates, junior faculty, or established investigators who wish to develop or refocus their careers on biodefense research. RCE career development programs are not intended for predoctoral candidates. Each application should include at least two career development projects, it is recommended that one be focused on basic research and one involving translational and/or clinical activities, others may be added at the discretion of the consortium leadership. The training must be an integral part of the strategic plan, and complement the research activities. The long-range goal of the training component is development of an expanded cadre of new researchers, clinicians, and technical personnel who can help lead the national biodefense mission into the future. This may include continuing education for current health professionals and faculty/staff interested in starting and pursuing research in the areas of biodefense and emerging infectious diseases. The description of these plans should include the policies, criteria, and processes fro selecting candidates, including special efforts to recruiter qualified women and minorities. The NIAID supports a variety of training and career development opportunities, including various T, K, and F awards, and applicants are encouraged to supplement RCE activities by applying for direct training support. For information see: NIH Guide Notice NOT-AI-02-024. 4. Developmental Projects Every RCE must identify and support Developmental Projects that take advantage of developing technology and new research opportunities, from basic to clinical. These projects may involve scientists within the RCE, or extend to appropriate regional scientists outside the Center. The RCE application must propose an institutional review process for selecting the most promising Developmental Projects for funding, consistent with the strategic plan and the overall RCE Program goals. A key goal is expanding the scope and range of research, investigators, and institutions involved in biodefense research. While the specific number of developmental projects to be proposed is at the discretion of the applicant, funding for all of the developmental studies may not exceed $500,000 any one year, with no more than $100,000 for any one study. Individual Developmental Projects are expected to have small budgets since the Cores will likely provide significant support. It is anticipated that some developmental 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 choices of developmental projects and the growth of successful developmental studies into new NIAID grants to advance specific vaccines, therapeutics, diagnostics or basic science/clinical studies. These funds are intended to remain flexible and to support studies of a limited duration, e.g., two years or less. The use of developmental projects permits maximal flexibility to proceed in the directions that seem most scientifically fruitful, successful developmental projects may also grow and replace full 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. The plan for selection and phasing in and out of projects as well as for management of developmental funds must be spelled out in the application, and if the plan is approved, it will be incorporated into the terms of award of the RCE. 5. Administrative and Facilities Cores An Administrative Core must be included. The RCE PI must be director of the Administrative Core and must commit at least 20% effort to these responsibilities, in addition to his/her own RCE research activities. The Administrative Core director and staff are responsible for managing, coordinating, and supervising the entire range of Center activities, monitoring progress and making sure the strategic plan is carried through. This includes making sure appropriate systems are in place to provide for biosafety and security of materials, data, and facilities. 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 end goal being development of clinically useful biodefense vaccines, therapeutics or diagnostics. The RCE concept is intended to promote flexibility, with the discontinuance of research projects with little translational potential and the initiation of new projects with greater potential expected as the program evolves and matures. 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 need to facilitate and add to the research and training plans, and lead to new regional biodefense capacity. The cores, their use for the research, and why they are needed must be described in the application. As part of the application, 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. 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. A pre-solicitation notice for the Regional Biocontainment Facilities has been announced at https://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-038.html for construction of and operation of BSL3/4 facilities. Applicants must describe in detail their research and training plans that will require high level containment facilities, and provide a description of what they have available currently. If plans and arrangements have made at the time of application for linkages to groups that are applying to be RBL contractors or with other planned or existing containment facilities these should be described. Finally, applicants should discuss what resources they will need to arrange with the help of NIAID staff if an award is made, and once the RBL contractors have been selected. MECHANISM OF SUPPORT This RFA will use the U54 award mechanism. The NIH U54 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, however, substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during the performance of the activities. Under a cooperative agreement, the NIH"s purpose is to support and stimulate the recipient"s activities by involvement in and otherwise working jointly with the award recipient in a partner role. 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 activities from very basic to clinical. FUNDS AVAILABLE For FY2003 the NIAID intends to commit approximately $40 million to fund up to 4 RCEs in response to this RFA. 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. 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 meritorious applications. At this time the NIAID is planning a second receipt date for applications to be funded from FY2004 funds. However, this competition is dependent on availability of funds and future decisions about NIAID Biodefense priorities. Another RFA that describes the P-RCE program, a U56 cooperative agreement program, will appear soon. That program will provide funds for start up and developmental activities that will lead to RCE applications. REGIONAL DEFINITIONS To achieve nationwide distribution of the RCEs, the NIAID has divided the United States into 10 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. ELIGIBLE INSTITUTIONS A group of collaborating investigators at one institution or 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 category A-C agents, with emphasis on at least one category A agent, may apply. An application must contain several interactive research projects that constitute an interdisciplinary, multi-platform-based, approach to these agents and that will lead to the development of therapeutics, vaccines, or diagnostics for them. Applications will not be accepted that focus exclusively on clinical research or exclusively on basic research, or that are limited to epidemiological or large scale clinical trials. The consortium must also be able to conduct appropriate training activities, and is dependent on availability of needed facilities, including BSL3/4 capacity, although no group is expected to have all required facilities at the time of application. NIAID staff will work with successful applicants to provide access to BSL3/4 facilities. Broadly based applicant groups are encouraged. 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 proposed research 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. Foreign organizations are not eligible to serve as grantees and may not be part of domestic applications. Principal Investigators must be United States citizens. All investigators in RCE activities who handle CDC Category A Agents must be United States citizens. SPECIAL REQUIREMENTS 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. Awardee Rights and Responsibilities: a. 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 therapeutic, vaccine and diagnostic products and other research tools and research materials they develop available to the biodefense and emerging infectious disease research community through the NIAID Biodefense and Emerging Infectious Diseases Research Resources Program. b. Awardees agree to participate in projects identified by the Management and Oversight Committee that include common research interests that address a specific problem or threat. c. The Principal Investigator must attend and participate as a voting member in regular meetings of the NIAID RCE/RBL Management and Oversight Committee to discuss progress and directions of research and to ensure that overall Program goals are being met. d. The Principal Investigator must coordinate and participate in regular, local meetings of the RCE 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 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. e. The Principal Investigator and appropriate other RCE investigators will attend an RCE Program Annual Meeting to be organized by NIAID staff in Washington, D.C. Each RCE will submit semi-annual progress reports to the NIAID that describe activities and accomplishments during the previous funding/reporting period. 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 role 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. 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: (http://ott.od.nih.gov/). g. Intellectual Property Plan. In order to encourage timely presentation and publication of results, the RCEs are encouraged to file patent applications in a timely manner, according to an approved implementation plan. Applicants shall include in their application the following terms concerning intellectual property rights, or provide an alternative plan. In no event will an award be made absent incorporation of either the RCEs terms below, or the applicant"s own plan. "Each institution participating in the RCE agrees to grant to commercial collaborator: (i) a paid-up nonexclusive, nontransferable, royalty-free, world-wide license to all RCE Inventions for research purposes only, and (ii) a time-limited first option to negotiate an exclusive, world-wide royalty- bearing license for all commercial purposes, including the right to sub- license, to all inventions on terms to be negotiated in good faith by the collaborator and Institution. The collaborator shall notify Institution, in writing, of its interest in obtaining such an exclusive license to any Institution Invention within six (6) months of the collaborator"s receipt of notice of such Institution Invention(s). In the event that a collaborator fails to so notify Institution, or elects not to obtain an exclusive license, then the collaborator"s option shall expire with respect to that Institution Invention, and Institution will be free to dispose of its interests in such invention in accordance with participating Institution"s policies. If the participating institution and collaborator fail to reach agreement within ninety (90) days, (or such additional period as collaborator and Institution may agree) on the terms for an exclusive license for a particular Institution Invention, then for a period of six (6) months thereafter Institution shall not offer to license the invention to any third party on materially better terms than those last offered to collaborator without first offering such terms to collaborator, in which case collaborator shall have a period of thirty (30) days in which to accept or reject the offer. Participating institution agrees that notwithstanding anything contained herein to the contrary, any inventions, discoveries or innovations, whether patentable or not, which are not Subject inventions as defined in 35 USC 201(e), arising out of any unauthorized use of the collaborator"s agent and/or any modifications to the agent, shall be the property of the collaborator (hereinafter "Collaborator Inventions"). Institution will promptly notify the collaborator in writing of any such Collaborator Inventions and, at collaborator"s request and expense, participating institution will cause to be assigned to collaborator all right, title and interest in and to any such collaborator inventions and provide collaborator with assignment or other documents). Participating institution may also be conducting other research using the agent under the authority of a separate Material transfer Agreement (MTA) with the collaborator. Inventions arising there under shall be subject to the terms of the MTA, and not to this clause." 35 USC. h. Protection of Proprietary Data Raw and primary data may be provided exclusively to the NIAID, industrial collaborators, and the FDA, as appropriate. This provision shall not affect the investigators" right to disseminate their research findings through publications or presentations. 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 PI. The RCE Program Director from the Division of Microbiology and Infectious Diseases and Program Staff Scientists 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. b. The NIAID Program Staff Scientist will monitor the progress of the RCE, helping coordinate research approaches between Centers, and contributing to the adjustment of research projects or approaches as warranted. The NIAID Project Staff Scientist will assist and facilitate this process and not direct it. This individual 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 Management and Oversight Committee for advice. d. The NIAID Program Staff Scientist will keep the RCE informed about other ongoing studies supported by NIAID to avoid duplication of effort and to encourage sharing and 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 resources from NIAID, including NIAID sponsored agents for preclinical and clinical testing, drug screening, preclinical toxicology testing, and assistance in IND filing, etc. NIAID Program Staff Scientists 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. e. NIAID RCE Program Staff Scientists will help organize an annual meeting of investigators from all funded RCEs to share progress and research insights that may benefit all of the projects. The RCE Program Director will be responsible for conducting semi-annual meetings of the Management and Oversight Committee. f. The RCE Program Staff Scientist may assist, where warranted, in data analyses, interpretations, 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. 3. Collaborative responsibilities: The Management and Oversight Committee (MOC) will provide overall scientific coordination of the RCE Program, RCE Principal Investigators, Directors of the RBLs (BSL3/4 facilities), and the NIAID RCE Program Director will be voting members. Additional NIAID Program Staff and scientists other than PIs may attend as non-voting members of the committee, where additional expertise may be required. The NIAID RCE Program Director will serve as chairperson. The Management and Oversight Committee will meet twice yearly 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 Program. The Committee may determine the need to redirect certain efforts in RCEs 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 this Committee. The Committee will be called upon to make recommendations regarding approaches to specific threat agents and emerging diseases that require new attention as the need arises. The Committee will also seek input from the scientific research communities, and help the NIAID determine initiatives that will have an impact on the health and safety of the nation. The MOC will also provide a forum for coordinating RCE activities that require a liaison function with other federal agencies such as FDA, USDA, and CDC. 4. 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. WHERE TO SEND INQUIRIES Written and telephone inquiries from potential applicants to clarify any issues or questions about the RCE Program and responding to the RFA are welcome. Direct inquiries regarding programmatic issues and address the letter of intent to: Dr. Rona Hirschberg RCE Program Director Division of Microbiology and Infectious Diseases National Institute of Allergy and Infections Diseases 6700B Rockledge Drive, Room 3129, MSC 7630 Bethesda, MD 20892-7630 Zip code for express couriers: 20817 Telephone (301) 496-1884 Fax: (301) 480-4528 e-mail: rhirschberg@niaid.nih.gov Direct inquiries regarding review issues to: Edward W. Schroder, Ph.D. Chief, Microbiology and Immunology Review Branch NIAID Scientific Review Program 6700-B Rockledge Drive MSC 7616 Bethesda, MD 20892-7616 Zip code for express couriers: 20817 Phone: 301-435-8537 FAX: 301-402-2638 e-mail: es170m@nih.gov Direct inquiries regarding fiscal matters to: Linda Shaw Grants Management Branch Division of Extramural Activities National Institute of Allergy and Infectious Disease, NIH 6700-B Rockledge Drive, MSC 7614 Room 2125 Bethesda, MD 20892-7614 (Express Zip 20817) Email: ls15k@nih.gov Tel: (301) 402-6611 Fax: (301) 480-3780 Lesia A. Norwood Grants Management Branch Division of Extramural Activities National Institute of Allergy and Infectious Disease, NIH 6700-B Rockledge Drive, MSC 7614 Room 2117 Bethesda, MD 20892-7614 (Express Zip 20817) Email: ln5t@nih.gov Tel: (301) 402-7146 Fax: (301) 480-3780 LETTER OF INTENT Prospective applicants are asked to submit a letter of intent that includes the following information: o Number and title of this RFA o Descriptive title of the proposed application o Region (see list above) o Names of Institution(s) participating in the RCE application o Name, address and telephone number of the Principal Investigator o Names of other key personnel 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 is to be sent by the date listed at the beginning of this document. The letter of intent should be sent to: Edward W. Schroder, Ph.D. Chief, Microbiology and Immunology Review Branch NIAID Scientific Review Program 6700-B Rockledge Drive MSC 7616 Bethesda, MD 20892-7616 Zip code for express couriers: 20817 Phone: 301-435-8537 FAX: 301-402-2638 e-mail: es170m@nih.gov SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://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. The total application may not exceed 300 pages, and no more than 200 pages of appendix material may be included. Applications exceeding these limits will be returned without review. In addition, applicants must consult and use "Instructions for Applications for Multi-Project Awards" (http://www.niaid.nih.gov/ncn/grants/multibron.htm ) with the following additional instructions specific to this RFA. Table of Contents: Organize the application and table of contents as described below: Face Page Description, performance sites and key personnel Table of contents Detailed Budget for Initial Budget Period: Administrative core Research Projects Developmental projects Training projects Facilities cores Budget for entire project period Budgets pertaining to consortium/contractual arrangements Biographical sketch of the Principal Investigator (not to exceed two pages) Biographical sketch of the Research Project Investigators (not to exceed two pages each) Biographical sketch of other Key Personnel including Core Directors(not to exceed two pages each) List of all participating members of the Center A. Introduction (15 pages) Background and objectives Letter of commitment from Institution(s) Chronological review of planning and priority setting processes B. Strategic Plan (20 pages) Strengths Opportunities Action Plan Outcome Measures Emergency Response Plan C. Research Projects (25 pages (sections A-D of the 398 form) or less each, maximum of 150 pages total) Use standard R01 sections and budget pages for each D. Career Development Projects (10 pages or less each, maximum of 30 pages) Basic Science Translational/clinical Other Budget E. Developmental Projects (maximum of 20 pages total) Process for review and award Assessment process, including termination or promotion Proposals for first years" awards (2-3) Budget F. Cores and Facilities (15 pages or less each, maximum of 70 pages) Administrative Core with detailed budget Other Cores with budgets Discussion/documentation of need for BSL3/4 facilities, including renovation plans, if planned SUPPLEMENTAL INSTRUCTIONS: A collaborating NIH Intramural Scientist (IMS) may not receive salary, equipment, supplies, or other remuneration from this RFA. The IMS must obtain approval of his/her NIH Institute Scientific Director to allocate resources to the project. This letter 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 of vertebrate animal research.). Each applicant RCE must provide in the application a detailed description of the approach to be used for obtaining patent coverage and for licensing where appropriate, in particular where the invention may involve investigators from more than one institution, and a signed agreement between all parties must be included. Procedures must be described for resolution of legal problems should they arise. Your attention is drawn to P.L. 96-517 as amended by P.L. 98-620 and 37 CFR Part 401. Instructions were also published in the NIH Guide for Grants and Contracts (NIH Guide, Vol. 19, No. 23, June 22, 1990).) NIAID acknowledges that some commercial collaborators that are members of applicant RCEs, or who provide material to applicant RCEs, may require that Institution agree to grant to them certain intellectual property rights, as described by the terms above. If Institution voluntarily agrees to the described terms, then they should appear in the RCE application. NIAID recognizes that Institutions" and consortia of Institutions" ability to access agents from commercial collaborators for this effort may be limited in the absence of such a voluntary agreement, or a substantially similar independent agreement between Institution and commercial collaborators providing agents. However, in no event will the award of cooperative agreement be dependent upon the described terms" being part of an RCE application. Rather, the consortia and the Institution"s application may provide Institution"s own plan for accessing agents from commercial collaborators. 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: https://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 copies of appendix material for the application must also be sent to: Edward W. Schroder, Ph.D. Chief, Microbiology and Immunology Review Branch NIAID Scientific Review Program 6700-B Rockledge Drive MSC 7616 Bethesda, MD 20892-7616 Zip code for express couriers: 20817 Phone: 301-435-8537 FAX: 301-402-2638 e-mail: es170m@nih.gov APPLICATION PROCESSING: Applications must be received by the receipt date listed. 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. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an Introduction addressing the previous critique. 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.) (https://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 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html. 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. 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 Division of Extramural Affairs (DEA) at NIAID, in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o Undergo a 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 second level review by the National Institute Allergy and Infectious Diseases Advisory Board. REVIEW CRITERIA o 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 review elements listed below. The Strategic Plan, the individual Research Projects, the career development projects as a whole, and the developmental projects as a whole, will be assigned numerical priority scores, while the Administrative and Facilities Cores will be rated acceptable or unacceptable without numeric scores. The overall score will be based on the scientific merit of the individual components as well as the overall synergy, 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 overall NIAID Biodefense mission. Criteria and factors to consider for evaluation of the application components: 1. Overall strategic plan, management and goals of the Center a. Strategic Plan (1) Feasibility of the proposed strategic plan to achieve goals that are appropriate to the mission of the RCE. (2) Scientific / technical merit and innovation of the proposed goals of the RCE. (3) Potential for the proposed plans for the RCE to enhance regional research and development capabilities. (4) Potential for the proposed RCE to develop critical, new knowledge about biodefense and emerging infectious diseases. (5) Potential for the proposed research goals to lead to vaccines, diagnostics and therapeutics for category A-C agents. (6) Feasibility of the proposed research to span basic as well as translational / clinical issues. b. Communications, Collaborations, and Interactions (1) Strength, merit and feasibility of plans to foster synergistic interactions among the participants of the proposed Center. (2) Strength, merit and feasibility of plans for Center interactions with federal, state and local agencies or with industrial partners. (3) Strength, merit and feasibility of plans for rapid and effective communication among the proposed participants and with the broader constituency of the Center. c. Monitoring and Evaluation (1) Scientific and technical merit and feasibility of the proposed milestones. (2) Appropriateness and feasibility of the proposed means to measure and assess productivity. (3) Appropriateness and feasibility of plans to add research projects and / or cores in response to emerging opportunities or to delete unproductive projects and/or cores. d. Institutional Commitment (1) Merit and appropriateness of the documented institutional support to the goals of the Center, including the commitment of additional resources. (2) Strength, merit and feasibility of documented plans to leverage additional scientific and technical resources to increase the impact of NIAID funds. (3) Merit and feasibility of the documented capacity and interest of the proposed institution(s) to serve as a regional biodefense first responder. (4) Appropriateness and feasibility of plans to rapidly develop the Center. 2. Administrative Core a. Adequacy of the training, experience, level of commitment, availability and qualifications of the Principal Investigator to successfully lead and manage the proposed Center. b. Adequacy of the training, experience, levels of commitment, availability and qualifications of key personnel who represent the leadership team proposed for the Center. c. Appropriateness and clarity of plans for organizing the Center"s activities for prioritization of competing needs. d. Appropriateness and clarity of the organizational structure and lines of authority as well as plans for lines of authority in the Principal Investigator"s absence. e. Appropriateness of plans to make the Center and its resources available to investigators and institutions throughout the region. f. Appropriateness of the management plan for fiscal accountability and communications within the Center. 3. Evaluation of research projects The following review criteria for research projects will be applied in the context of how the project supports the strategic plan and advances the overall program of the Center. SIGNIFICANCE: appropriateness of the research proposed in advancing the biodefense mission of the NIAID, contributing to the RCE strategic plan, and in inclusion of an appropriate representation of category A-C agents. APPROACH: appropriateness of the conceptual framework, design, methods, and analyses to the aims of the project and the RCE program. An effective strategy for selecting approaches and platforms 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. INNOVATION: novelty of concepts, approaches or methods. Project leaders should seek to advance, extend or challenge existing paradigms, or to develop new methodologies or technologies for biodefense. INVESTIGATOR: appropriateness of the training, qualifications, experience, accomplishments of the project leader to carry out the proposed project. The project leader is expected to allocate sufficient effort to RCE activities. The application should provide documentation that project leaders have the ability and willingness to function as part of an RCE team. ENVIRONMENT: adequacy of the availability of personnel at the institution(s) who are experienced with CDC 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 integration of the project into Center activities. When appropriate, individual projects may be grouped as programs within the Center to address overarching scientific aims. Such programs 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. 4. Evaluation of Career Development Plans a. Quality and appropriateness of the technical and scientific expertise, mentoring experience and availability of the faculty and staff to conduct the proposed training. b. Strength of the documented available training infrastructure such as laboratories, clinics, etc. c. Merit, feasibility and level of creativity of the proposed approaches to increase the human resources available for biodefense. d. Relevance of the proposed training to, and integration with, the goals of the strategic plan. e. Feasibility and strength of plans to recruit sufficient qualified students and trainees and adequacy of plans for the inclusion of women and minorities. f. Appropriateness of the proposed training within the current education framework of the involved institution(s). g. Potential contribution of the specific training proposed to the overall RCE mission. h. Suitability of plans for evaluation of the training and documenting success. 5. Evaluation of Developmental Project plan a. Strength, feasibility and appropriateness of the proposed plans and criteria to select developmental projects and monitor their long term success. b. Scientific merits of the sample developmental projects provided, and their suitability to the overall goals and priorities of the Center. c. Inclusiveness and feasibility of the developmental project plan for bringing new investigators into the biodefense research area. d. Adequacy of the proposed procedures and criteria for the phase-in and phase-out of developmental projects and for the promotion of promising developmental projects to full research status. e. Adequacy of the plans of the leadership for selecting developmental projects that leverage resources and complement the Center"s strengths. f. Appropriateness and clarity of plans to manage the budgets of developmental projects. g. Appropriateness and feasibility of recruitment strategies to ensure a broad pool of applicants and scientific topics for the development projects. 6. Evaluation of core facilities plans a. Appropriateness of the proposed core facilities in the context of the overall strategic plan and the proposed research and training activities. b. Feasibility and clarity of plans for prioritizing the use of facilities and for allocating availability to the proposed research projects. c. Qualifications, experience and commitment of key personnel for running the core facilities. d. Documented importance of the core proposed in the context of existing facilities in the Center and region. e. Adequacy and feasibility of plans to ensure that the core facilities are used to fullest extent including access by non-RCE investigators and institutions. f. 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. g. Appropriateness of the schedule of user fees set to ensure broad accessibility and utilization by regional partners, particularly those with limited resources. 7. BSL3/4 Utilization plans a. Clarity of documentation of the need for BSL3/4 facilities. b. Adequacy and feasibility of plans to establish linkages to exisiting BSL3/4 facilities. c. Collective experience of Center participants in the use biocontainment facilities and ability to provide training for proposed biocontainment facilities. d. Adequacy and feasibility of the phase in plans providing a mechanism for research to proceed until new BSL3/4 capacity is on-line. ADDITIONAL REVIEW CRITERIA: In addition each of the research projects, as well as planned developmental projects, and the project as a whole will be evaluated with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o INCLUSION: 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 included in the section on Federal Citations, below) o DATA SHARING: The adequacy of the proposed plan to share data. o BUDGET: The initial review group will also examine the reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The support for attendance at Management and Oversight Committee meetings can be provided through the Team"s award as part of the travel budget. RECEIPT AND REVIEW SCHEDULE Letter of Intent Receipt Date: November 15, 2002 Application Receipt Date: January 15, 2003 Peer Review: May 2003 Earliest Anticipated Award Date: August 2003 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 expand/change the scope of the proposed research to meet overall program needs. Additional award criteria that will be used to make award decisions include: o Scientific merit (as determined by peer review) o Availability of funds o Programmatic priorities o Coverage of desired research scope o Regional distribution of meritorious applications REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: https://grants.nih.gov/grants/guide/notice-files/not98-084.html). Clinical trials supported or performed by NIAID require special considerations. It is anticipated that the RCEs will run very limited proof of concept trials, and limited safety studies of new agents. Activities beyond this will require approval by the full Management and operations committee. 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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html), a complete copy of the updated Guidelines are available at https://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 https://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. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research in now available online. RECOMBINANT DNA AND HUMAN GENE TRANSFER RESEARCH The National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines) apply to NIH-funded and non-NIH- funded gene transfer projects that are conducted at or sponsored by an institution that receives NIH support for recombinant DNA research. As defined by the NIH Guidelines, recombinant DNA molecules are either: (1) molecules which are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or (2) DNA molecules that result from the replication of those described in (1). The NIH Guidelines set forth principles and standards for safe and ethical conduct of recombinant DNA research and apply to both basic and clinical research studies. Specific guidance for the conduct of human gene transfer studies appears in the appendix of the document (Appendix M.) The NIH Guidelines should be carefully reviewed to ensure compliance with all other requirements for the conduct of projects involving recombinant DNA research and human gene transfer. Failure to comply with the NIH Guidelines may result in suspension, limitation, or termination of NIH funds for recombinant DNA research at the organization or a requirement for NIH prior approval of any or all recombinant DNA projects at the organization. A copy of the NIH Guidelines is posted at the following URL: http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html and may be obtained from the NIH Office of Biotechnology Activities, 6705 Rockledge Drive, Suite 750, Bethesda, MD 20892, 301-496-9838. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at https://grants.nih.gov/grants/stem_cells.htm and at https://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 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 https://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. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.3393 and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 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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