PLANNING GRANTS FOR REGIONAL CENTERS OF EXCELLENCE FOR BIODEFENSE AND EMERGING INFECTIOUS DISEASES RESEARCH (P-RCE) RELEASE DATE: October 1, 2002 (see amendment NOT-AI-03-005) RFA: AI-02-050 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 Regional Definitions o Individuals Eligible to Become Principal Investigators o Terms and Conditions of Award 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 OF THIS RFA The National Institute of Allergy and Infectious Diseases (NIAID) invites planning grant applications (U56) to support planning for and development of applications (U54) to the Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) Program. The overall goal of this RFA is to support planning, research program initiation, and resource acquisition that could lead to the establishment of a regional center, whose purpose is to develop and maintain the research and development response capacity to rapidly evaluate and counter new bioterrorism or emerging infectious disease events. It is expected that at the end of this planning grant, the principal investigator and the team of researchers that has been assembled will submit an application for a RCE award. The RCE Program is detailed in RFA AI-02-031. Briefly, the RCE program's goal 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 NIAID Category A-C Agents http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm with particular emphasis on Category A. To accomplish this, 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 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 NIAID 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. The RCE RFA invites research institutions and groups of investigators to form consortia or collaborations and develop applications for programs that will address the fundamental research and development questions that will provide the information needed to counter the threat of bioterrorism. Diverse research and development approaches are encouraged, as long as they include the following essential features: a biodefense research focus on NIAID 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 essential to lead the research thrust, which underlies all the other activities of the RCE. Successful applicants for Planning Grants for Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases (P-RCE) will become part of a national, NIAID-managed Biodefense/emerging infectious diseases network that will be coordinated by the NIAID RCE Management and Oversight Committee. 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://www2.niaid.nih.gov/biodefense/). To facilitate this initiative, the NIAID has established The Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) Program. Additionally, NIAID is establishing this planning grant activity to assist interested investigators and institutions in developing plans for a Regional Center of Excellence. Objective and Scope The U56 planning grant supports the establishment of a structure and a program that is focused on multidisciplinary approaches to understanding, preventing, diagnosing and treating infections caused by the NIAID category A-C agents and other emerging infectious diseases. Applicants for this Planning Grant for Regional Centers of Excellence for Bioterrorism and Emerging Infectious Diseases Research (P-RCE) will be expected to work toward the following objectives during the course of an award: 1) establish the leadership team for the RCE; 2) establish the long-range strategic plan for the proposed Center; 3) define research objectives and projects, as well as cores for the RCE; 4) initiate research projects and begin facilities development; and 5) submit an application to the RCE program (U54). 1. Defining the Principal Investigator, applicant organization and consortium partners. A key issue in planning a regional center is the selection of the PI, consortium partners, and applicant organization. The group considering formation of a Regional Center must assess the potential PI and other researchers with regard to commitment of sufficient effort, prior experience of the PI and the applicant organization with large multi-institutional research projects, and the ability to lead. The applicant institution must be willing to provide the necessary space as well as managerial and fiscal support for the Center. The PI and leadership team should be tentatively identified at the time of application for the P-RCE grant although the team may change before an RCE application is developed. 2. Developing a Strategic Plan. A major goal of the planning process is the establishment of a strategic plan to identify the most significant opportunities and gaps in science that would be addressed by a Regional Center of Excellence in the short and long term, and to identify objective milestones to measure success or failure. The outlines of the strategic plan should be defined at the time of applying for the P-RCE, although complete development would occur during the period of the award. The following process and organization is suggested for the strategic plan: a) Summary of current research of P-RCE participants and the current facilities and resources available. Outline the major infectious disease, immunity, and biodefense related studies to be assisted by P-RCE, and eventually, if successful, RCE funding. b) Opportunities - Identify and evaluate potential opportunities for use of P-RCE resources. This analysis will require outreach for suggestions from all members of the consortium. The NIAID strongly encourages the planning group to form associations with other federal agencies, such as intramural NIH, CDC, DoD, Dept of Agriculture, DOE National Laboratories, and with state and local health departments. As part of this process the planning group should document the collaborations with the institutions in their region that were considered and which will be further developed to both utilize their unique strengths and address the mission of the RCE Program. c) Action Plan - Choose the highest priority opportunities and develop a detailed plan for the two years of funding. As part of the planning process, an overall research theme should emerge. This should help provide a measure to determine if planned activities contribute to the overall theme. Examples of action plan steps include: determining which cores will be established; determining how existing BSL2/3 resources will be utilized; planning for leveraging of resources for renovation/expansion if needed; developing support for new research projects; establishing channels for communication and outreach. d) Outcome Measurements - Determine how progress on action plans will be measured. Include justification of ways that P-RCE funding would provide unique contributions that cannot be provided by other types of research awards. Define criteria for measuring progress on long-term goals for the entire funding period, and include semi-annual milestones for the each year. Specifically, address the timetable and milestones for submitting an RCE application. e) Emergency Response Plan - Determine who the partners and contacts would be in the case of a local, regional or national biodefense crisis. This should include plans for working with potential partners to establish procedures and systems for the planned center's regional research role in assisting in the response. 3. Planning the Research Projects. As part of the planning process, the leadership team should begin to develop independent, competitive, research projects, addressing the research agenda for the NIAID category A-C agents. Each P-RCE application must include a detailed proposal and budget for one new meritorious research project; a second one may be included. In addition, the application must describe how other research projects will be identified during the award period so that the required five projects are in place for the RCE application. 4. Planning the Career Development Projects. As part of the action plan, describe how the highest priority training needs will be identified and how plans for implementing them will be developed and established. 5. Planning a Developmental Projects system. Describe how the P-RCE will establish a process for the selection, monitoring and evaluating of developmental projects. These will be small-scale, untested research activities that would, if successful, contribute to the goal of developing a full RCE application and advance the goals of the NIAID biodefense agenda. It is anticipated that the successful developmental projects will become the basis for research projects in the RCE application. Plans for one or more developmental projects may be included, with a budget, with the objective of testing them as possible research project components for the RCE application. 6. Planning Core Facilities. Describe as part of the strategic plan, the process for identification of core facilities. Then discuss how the cores will be developed and maintained and how the Center will assess the success or failure of a core. Acquisition of core facility equipment, and renovation of facilities may be supported by the P-RCE award, and implementation may begin as soon as an award is made. 7. Biocontainment Assessment. A necessary component of a Center's success will be the availability of adequate access to BSL3/4 biocontainment facilities. Applicants must describe their plans that would require such facilities, and provide a description of what facilities are available currently, what plans and arrangements have made at the time of application for linkages to groups that are applying to build NIAID-funded facilities or with other planned or existing containment facilities, and what resources they will need to arrange with the help of NIAID staff if an award is made, and once the construction awardees have been selected. MECHANISM OF SUPPORT This RFA will use the U56 award mechanism. The NIH U56 is a cooperative agreement planning 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". FUNDS AVAILABLE The NIAID intends to commit approximately $4-8 million in FY 2003 to fund about 4-8 P-RCEs in response to this RFA. An applicant may request up to $1M total direct costs and a project period of up to two years. Current NIAID plans do not include support for this program beyond this competition. Since this award is not renewable, it is assumed that recipients of awards under this RFA will compete for Regional Centers of Excellence awards at the end of this planning grant, or acquire other support to continue their activities. Awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. ELIGIBLE INSTITUTIONS Any consortium consisting of a group of investigators at more than one institution, or a group of collaborating investigators at one institution, who are planning to work 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. A consortium may include institutions from other regions. Institutions and consortia that are submitting RCE applications may not apply to this competition. 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 Foreign organizations are not eligible to serve as grantees and may not be part of domestic applications. REGIONAL DEFINITIONS To achieve nationwide distribution of the RCEs, the NIAID has divided the United States into 10 regions based on the HHS system. 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. 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. SPECIAL REQUIREMENTS Cooperative Agreement Terms and Conditions of Award The administrative and funding instrument used for this program is a cooperative centers agreement planning award mechanism (U56), 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. The NIH purpose is to support and stimulate the activity by working jointly with the recipient in a partner role, but it is not to assume direction, prime responsibility or a dominant role in the activity. The prime responsibility for the research resides with the awardees, although some activities may be carried out as collaborations among the awardees with coordination and facilitation by the NIAID Program staff as described below. 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. b. The Principal Investigator must attend and participate as a non-voting member in regular meetings of the NIAID RCE Management and Oversight Committee to discuss progress and directions of research and to ensure that overall RCE Program goals are being met. c. The Principal Investigator must coordinate and participate in regular meetings of the local Center planning group with the two-year goal of developing an application for a Regional Center of Excellence grant. This will require discussions about progress and directions of research to ensure that the necessary interdisciplinary interactions are forming and that the planning processes are on schedule. d. The Principal Investigator and other appropriate investigators will attend a RCE Program Annual Meeting to be organized by NIAID staff in the Washington, D.C area. Each P-RCE will submit semi-annual progress reports to the NIAID that describe activities and accomplishments during the previous funding/reporting period. e. An NIH intramural scientist (IMS) or other federal employee may not serve as the Principal Investigator but may participate as part of the Center. 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. These rules apply to scientists employed by other parts of the federal government as well. 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 P-RCEs are encouraged to file patent applications in a timely manner, according to an approved implementation plan. Awardees shall include 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 P-RCEs terms below, or the applicant's own plan. "Each institution participating in the P-RCE agrees to grant to commercial collaborator: (i) a paid-up nonexclusive, nontransferable, royalty-free, world-wide license to all P-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." 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 RCE Program Director from the Division of Microbiology and Infectious Diseases and NIAID Program Staff Scientists assigned to each P-RCE awardee will work closely with the PI and other member scientists to aid the efforts to develop toward an RCE application, to facilitate collaborations and to leverage the resources available to the Program. Other NIAID staff will be responsible for normal program stewardship and monitoring of award. b. NIAID Program Staff Scientists will coordinate activities that involve all the awardees and will work with Center leadership to help focus research efforts. The NIAID Program Staff Scientist, through the Management and Oversight Committee, may work to establish new research and development objectives within and among the P-RCEs based upon new scientific opportunity and national need. The NIAID Program Staff Scientist will assist and facilitate this process and not direct it. When necessary issues may be brought to the Management and Oversight Committee for advice. c. NIAID RCE Program Staff Scientists will help organize an annual meeting of investigators from all funded RCEs and P-RCEs to share progress and research insights that may benefit all of the projects and to accomplish the RCE Program's overall goals. 3. Collaborative responsibilities: a. The NIAID RCE Management and Oversight Committee will provide overall scientific coordination of the RCE Program; RCE Principal Investigators, Directors of the BSL3/4 cores, and the NIAID RCE Program Director will be voting members with the NIAID Program Director as Chairperson. Additional NIAID Program Staff, P-RCE Principal Investigators, and scientists other than PIs may attend as non-voting members of the committee, where additional expertise may be required. The P-RCE component of the Program will be guided by a sub-committee of the MOC that includes NIAID staff, RCE PIs and P-RCE PIs. The NIAID RCE Program Director will serve as chairperson. b. The Management and Oversight Committee will meet twice yearly or as needed in the event of a bioterrorism emergency. 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 and/or NIH intramural scientists and other federal government agencies; to establish priorities that will accelerate the translation of preclinical findings into clinical applications; to consider reallocating resources; and to conduct other business of the RCE Program. 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 P-RCE Program and responding to this RFA are welcome. Direct inquiries regarding programmatic issues 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 Email: 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 or 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 P-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 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. SUPPLEMENTAL INSTRUCTIONS. Sections A-F of the Research Plan (see below) may not exceed 100 pages if one research project is proposed or 125 pages if two research projects are proposed, and no more than 50 pages of appendix material may be included. Applications exceeding these limits will be returned without review. See "RESEARCH OBJECTIVES Objectives and Scope" above for information important to application preparation. In addition, applicants must consult and use "Instructions for Applications for Multi-Project Awards" at 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 Project - budget for each project Developmental projects - one budget for all planned activities Training projects Facilities cores one budget for all planned activities 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 other researchers associated with the P-RCE effort (not to exceed two pages each) Biographical sketch of other Key Personnel including anticipated Core Directors (not to exceed two pages each) List of all participating members of the Center A. Introduction (10 pages total) Background and objectives Letter of commitment from Institution(s) Chronological review of planning and priority setting processes B. Strategic Plan Status Report (15 pages total) Strengths Opportunities Action plan Outcome measures Emergency Response Plans C. Research Project(s) (25 pages or less for sections A-D for up to two projects) Use standard R01 format and budget pages Planning process to initiate other projects D. Identification and implementation of training activities (10 pages) E. Establishment of developmental projects (10 pages total) Process for review and award Assessment process, including termination or promotion to full research project status Project descriptions for immediate implementation, if any Budget F. Cores and Facilities (30 pages total) Administrative Core Other Cores Discussion/documentation of need for BSL3/4 facilities, including renovations, if planned Budget for all planned cores A collaborating NIH Intramural Scientist, or employee of another Federal Institution may not receive salary from this RFA. These scientists must obtain approval of his/her Scientific Director to receive additional funds for this 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 P-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. 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 P-RCEs, or who provide material to applicant P-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 P-RCE application. NIAID recognizes that Institutions' and consortia of Institutions' ability to access agents from commercial collaborators for this effort may be limited absent 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 a P-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: 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 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 Jan. 15, 2002. 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. 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 process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, 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 for Planning Grants for Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (P-RCE) The application as a whole will be evaluated using the following criteria: Significance The effect that a planning grant award would have on an institution, or consortium's biodefense and emerging infectious disease research efforts: 1. Evidence that the proposal will lead to development of a RCE application that would be competitive. 2. Documented focus on research projects and topics that includes NIAID category A-C agents and that may lead to new drugs, vaccines, and diagnostics for them. 3. Evidence of institutional commitment to the formation of an RCE. 4. Evidence that the strategic plan which is being developed will lead to a dynamic action plan that will result in strong linkages to the appropriate regional partners, outstanding research in biodefense and emerging infectious diseases, a quality training plan, and an energetic vision of what the P-RCE can become. Approach The likelihood that a planning grant will achieve its objectives, including the quality of the planning and management process, and the quality of the research proposed. 1. Clarity and feasibility of the strategic planning processes and strategies. 2. The ability of the proposed research projects to accomplish the stated goals and contribute to the biodefense effort, and the suitability of plans to select additional research projects. 3. The ability of the proposed cores to support the planned research efforts, foster drug, vaccine, and diagnostics development, and enhance the overall research environment, and produce an economy of scale. 4. Suitability of the plan to identify highest priority training needs to be addressed by Career Development Projects. 5. Appropriateness of the plans for selecting Developmental Projects and the scientific quality of the Developmental Projects included in the application. Innovation The utilization of planning grant resources in unique ways to achieve the long-term scientific goals of the RCE Program. 1. The creativity and quality of biodefense and emerging infectious diseases research that are proposed. 2. Creative acquisition and use of resources other than P-RCE funds, and establishment of innovative linkages to federal state, and local agencies and other regional partners. 3. Evidence that a P-RCE award would support novel and creative activities that cannot be supported other ways. 4. Evaluation of the process for establishment of an emergency response plan. Investigator The choice of appropriate leaders to carry out the Planning Grant and develop a RCE. 1. Designation of a P-RCE PI with appropriate managerial experience, commitment, leadership in biodefense or emerging infectious disease research; inclusion ofother appropriate leadership at the applicant institution and within the consortium (if applicable). 2. Qualifications of core directors and other key personnel, e.g., experience, competence and commitment. Environment the availability of resources and clear evidence of institutional commitment. 1. Existing resources available to the P-RCE. Included in this assessment is an evaluation of the prioritization process. 2. Commitment of consortium partners, including space, institutional financial support and other resources and oversight provided for P-RCE activities. 3. Appropriateness of the individual cores and the value of their contribution to the research environment. 4. Plans for prioritization of use of resources and making resources available to partners and others in the region. The Research Project(s) will be evaluated using the standard NIH criteria applied in the context of the RCE Program's goals. Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? Approach: Are the conceptual framework, design, methods, and analyzes adequately developed, well integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? Investigator: is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? 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. AWARD CRITERIA If an RCE or P-RCE has already been awarded within a region, the NIAID reserves the right to fund additional centers and planning grants within that region. Additional award criteria that may 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 the 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: http://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 P-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 (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. You will find this policy announcement 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://grants.nih.gov/grants/stem_cells.htm 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 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. 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 http://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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