and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National Institutes
of Health (NIH) (http://www.nih.gov)
Components of Participating Organizations
National Institute of
Allergy and Infectious Diseases (NIAID) (http://www.niaid.nih.gov)
Title: Regional Centers of Excellence for Biodefense
and Emerging Infectious Diseases Research (RCE) [U54]
Announcement Type
This RFA is a
re-issuance with modifications of RFA-AI-04-018,
which was previously released on April 1, 2004.
Update: The following update relating to this announcement has been issued:
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
Table of Contents
Part I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1.
Research Objectives
Section
II. Award Information
1.
Mechanism(s) of Support
2. Funds
Available
Section
III. Eligibility Information
1.
Eligible Applicants
A.
Eligible Institutions
B.
Eligible Individuals
2.Cost
Sharing or Matching
3. Other
- Special Eligibility Criteria
Section
IV. Application and Submission Information
1.
Address to Request Application Information
2.
Content and Form of Application Submission
3.
Submission Dates and Times
A.
Receipt and Review and Anticipated Start Dates
1.
Letter of Intent
B.
Sending an Application to the NIH
C.
Application Processing
4.
Intergovernmental Review
5.
Funding Restrictions
6. Other
Submission Requirements
Section
V. Application Review Information
1.
Criteria
2.
Review and Selection Process
A.
Additional Review Criteria
B.
Additional Review Considerations
C.
Sharing Research Data
D.
Sharing Research Resources
3.
Anticipated Announcement and Award Dates
Section
VI. Award Administration Information
1. Award
Notices
2.
Administrative and National Policy Requirements
A.
Cooperative Agreement Terms and Conditions of Award
1.
Principal Investigator Rights and Responsibilities
2. Consortium Plan
3. Meetings
4. NIH Intramural Scientist
Involvement
5. Monitoring Clinical
Studies
6. NIH
Responsibilities
7. Clinical Research
Responsibilities
8.
Collaborative Responsibilities
9.
Arbitration Process
3.
Reporting
Section
VII. Agency Contact(s)
1.
Scientific/Research Contact(s)
2. Peer
Review Contact(s)
3.
Financial/ Grants Management Contact(s)
Section VIII. Other Information - Required Federal Citations
Part
II - Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
PURPOSE
The National Institute of Allergy and Infectious Diseases (NIAID) is continuing the Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) Program. The overall goal of the RCE Program is to establish and maintain strong infrastructure and multifaceted research and development activities to provide scientific information and translational research capacity that will facilitate the next generation of therapeutics, diagnostics and vaccines against the NIAID Category A-C Priority Pathogens (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/default.htm) and emerging infectious disease (EID) agents (http://www3.niaid.nih.gov/research/topics/emerging/list.htm). To realize this goal, the Centers will be provided with support to: 1) develop and conduct programs of investigator-directed research; 2) train researchers and other personnel for biodefense and emerging infectious diseases research activities; 3) develop and maintain core facilities that support the research and training activities of the RCE; and make available these core facilities to qualified investigators from academia, biotechnology companies, the pharmaceutical industry, and other appropriate entities in the geographic region; 4) develop translational research capacity for testing and validating vaccine, diagnostic and therapeutic concepts for biodefense and emerging infectious diseases; and 5) be prepared and available to provide facilities and scientific support to first-line responders in the event of a national biodefense or EID emergency.
This Funding Opportunity Announcement (FOA) invites research institutions and groups of investigators to form consortia to develop and submit new or renewal applications for programs that address fundamental research and development questions that are expected to yield the information required to counter the threat of bioterrorism and EID. Diverse research and development approaches are encouraged, as long as they include a research focus on the NIAID Category A-C Priority Pathogens and EID agents. Applications may focus solely on Biodefense or may include a mix of Biodefense and EID. Additionally, consortia must document: institutional commitment, organizational capabilities, ability to develop and/or maintain core facilities, plans for training investigators and other participants in the national biodefense and EID effort, and interdisciplinary coordination and collaboration, particularly linkages to federal, state, and local agencies, as well as the academic and private sectors. Consortia must have a lead team of individuals responsible for the overall management and direction of the RCE. A group of Center member researchers, with expertise in biodefense and emerging infectious diseases, is required to lead the research thrust that underlies all activities of the RCE. This group will be the RCE Steering Committee. Centers should emphasize the use of cutting-edge approaches and technologies.
To ensure that the RCE Program contributes maximally and effectively to the NIAID biodefense and emerging infectious diseases effort, the overall direction and scope of activities of the Program and its participant Center sites will be coordinated and monitored by the NIAID RCE Program Office, in collaboration with the RCE Principal Investigators. The RCEs will be members of the NIAID Biodefense Network, a group consisting of the RCE Principal Investigators (PI), the National and Regional Biocontainment Laboratory PIs (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/research/resources/NBL_RBL/site.htm), and the NIAID RCE Program Office staff. The Network will meet at least annually to discuss matters of mutual interest and to coordinate activities.
To achieve nationwide distribution of the RCEs, applicants must propose Centers using the 10 established DHHS regions (http://www.hhs.gov/about/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 goal of the RCE Program, contingent upon the availability of funds and meritorious applications, to support up to ten new and/or renewal Centers. Applications from current RCEs and from other consortium groups will be accepted. The NIAID encourages applications from all regions of the country.
PUBLIC BRIEFING
An informational session for investigators representing groups considering submission of applications in response to this FOA will be held. Details will be announced on the NIAID Biodefense website (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/default.htm) and the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Representatives from the NIAID RCE Program Office and from the NIAID Division of Extramural Activities will provide information and answer questions pertinent to preparing applications in response to this FOA.
RESEARCH OBJECTIVES
Background
The NIH and other agencies in the Department of Health and Human Services (DHHS) support development of countermeasures to protect the public from bioterrorist threats and emerging infectious diseases. The biological agents deemed to pose the greatest threat are prioritized in the NIAID Category A, B and C Priority Pathogens and toxins (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/Cat.htm). The initial NIAID Strategic Plan for Biodefense Research (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/strategic_plan.pdf) was published in 2002 and followed by research agendas for Category A, B and C Priority Pathogens (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/about/strategicplan.htm). In 2007, the DHHS Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) published an Implementation Plan (http://www.hhs.gov/aspr/barda/phemce/enterprise/strategy/index.html), outlining strategies for identifying medical countermeasure requirements and establishing priorities for their research, development and acquisition.
NIAID recently published an updated Strategic Plan for Biodefense Research (http://www3.niaid.nih.gov/topics/BiodefenseRelated/Biodefense/PDF/biosp2007.pdf) that is consistent with the DHHS PHEMCE Implementation Plan and related components of the national biodefense strategy. The updated plan continues to focus on translation of basic research to product development, but with an emphasis shift from the current one bug-one drug approach towards a more flexible, broad spectrum approach. This approach is centered on development of countermeasures that are effective against multiple pathogens or toxins, development of technologies that can be widely applied to improve classes of products, and developing platforms that can reduce the time and cost of creating new products. The broad spectrum approach recognizes the expanding range of biological threats and the limited resources available to address each individual threat.
As one mechanism to achieve the goals described in the Strategic Plan for Biodefense Research, the NIAID established the Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) Program and is continuing it through the support of applications, received in response to this FOA, that are deemed to have the highest scientific merit. Each Center will serve a geographical region and is composed of investigators at several participating universities and/or research institutions, including government and the private sector.
Objective and Scope
This initiative supports the continuation of the Regional Centers of Excellence for Biodefense and Emerging Infectious Diseases Research (RCE) Program for the purpose of developing and maintaining research and development capacity, which is needed to assess and counter bioterrorism and emerging infectious disease threats. The mission and objective of the Centers are research and other activities related to biodefense and emerging infectious diseases. The RCE researchers are encouraged to collaborate with other NIH-funded investigators within and outside the Center region. In addition, the RCEs serve as a focal point to organize and promote relationships with pharmaceutical and biotechnology companies; with federal, state, and local agencies; and with other qualified investigators to foster translational research and promote maximal use of the core facilities and RCE expertise by a broad range of qualified scientists. In times of a national biodefense or EID emergency, the RCEs will be expected to rapidly realign their activities to assist response efforts within their region. This includes making their core facilities, scientific expertise, and other resources available to assist in the implementation of national emergency plans. To accomplish this, the Centers will receive support to: 1) develop and conduct programs of investigator-directed research; 2) train researchers and other personnel for biodefense and emerging infectious diseases research activities; 3) develop and maintain core facilities that support the research and training activities of the RCE; make available these core facilities to qualified investigators from academia, biotechnology companies, the pharmaceutical industry, and other appropriate entities in the geographic region; 4) develop translational research capacity for testing and validating vaccine, diagnostic and therapeutic concepts for biodefense and emerging infectious diseases; and 5) be prepared and available to provide facilities and scientific support to first responders in the event of a national biodefense or EID emergency.
The scope of acceptable areas for investigation includes research ranging from basic, to the basic/clinical interface, to clinical investigations, spanning the range of studies needed to establish a comprehensive national program for the NIAID Category A-C Priority Pathogens and EID agents. Small phase 1 clinical trials may be supported at the outset or small Phase 1 clinical trials that evolve from clinical studies proposed in the application during the life of the project may also be supported, dependent upon RCE Steering Committee and NIAID approval. Phase 2, 3, and/or 4 clinical trials are beyond the scope of this program and will not be supported. All Phase I clinical trials proposed as part of the application or during the project period must be conducted in existing clinical trial infrastructure, such as NIAID’s Vaccine and Treatment Evaluation Units, (http://www.niaid.nih.gov/factsheets/vteu.htm), the National Center for Research Resources Clinical and Translational Science Awards (http://www.ncrr.nih.gov/clinical_research_resources/clinical_and_translational_science_awards/), or facilities already established and maintained by NIH or the RCE-sponsoring institution, and approved by NIAID. RCE resources may not be used to develop clinical research infrastructure.
At this time, studies on Bacillus anthracis, orthopox viruses, and influenza are well represented within the NIAID research portfolio. Investigators are encouraged to focus on other Category A, B and C Priority Pathogens and EID agents, unless presenting exceptionally novel and unique concepts relating to these agents. Similarly, NIAID contracts support extensive microbial sequencing, bioinformatics, and proteomics efforts http://www3.niaid.nih.gov/research/topics/pathogen/; therefore, unless research proposed in an RCE application goes well beyond these contract capabilities, it will not be supported by the RCE Program. Applicants are strongly encouraged to take advantage of the publicly available NIAID sequencing, functional genomics, bioinformatics, structural genomics, and proteomics resources to satisfy their needs. A list of research areas that are considered relevant for the purposes of this FOA follows. This list is not all-inclusive, and prospective applicants are encouraged to discuss program relevance issues with the NIAID RCE Program staff cited under Agency Contacts (Section VII).
Examples of relevant research areas include, but are not limited to, the following areas:
In addition, research on zoonotic diseases may be supported if it is relevant to the biology, diagnosis and treatment of the disease in humans. For example, for zoonotic agents with an established or credible risk of transmission to humans, research in the animal host(s) and/or invertebrate vector(s) may be supported if it is relevant to understanding or mitigating the risk of transmission to humans or the ability of the agent to cause human disease. Projects outside of the scope of the NIAID’s mission, such as human disease surveillance, public health, animal health, health care delivery, and environmental surveillance, will not be supported.
With regard to product development, projects that address the following strategies are of particular interest:
Minimum Requirements of the Research Plan
The Research Plan portion of the application must minimally address the following requirements described below in sections A-E:
A. Background, Strategic Plan and Management of the RCE
1. Overview. Each RCE must structure its activities around one or a limited number of themes. In this section applicants should identify and describe the overall focus, including a brief discussion of the research theme(s), goals and objectives of the RCE; the organizational structure of the proposed Center; participating institutions/organizations; and the role of all consortium members.
2. Strategic Plan. The purpose of the Strategic Plan is to establish themes and identify unique opportunities for the RCE to contribute to biodefense and emerging infectious diseases research, as well as to identify unmet needs that may be addressed by the planned RCE activities. In the Strategic Plan applicants should provide a review of planning and priority setting processes that the consortium organizers used to develop the plan. The plan must include both short- and long-term goals, and must include descriptions of objective metrics that will be used to measure, assess and evaluate progress. The following framework is suggested for developing the Strategic Plan:
a. Strengths - Identify and describe the strengths of the proposed consortium, including a brief summary of the research and development experience and expertise of proposed RCE participants, as well as the current facilities and other research resources available. For those applicants who are currently supported by an RCE award, the applicant may describe the strengths of the RCE and lessons learned during the previous award period.
b. Opportunities - Identify and evaluate the potential opportunities to establish high quality research, training and development programs using RCE funds. RCEs are encouraged to form associations with other federal agencies, such as the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), the Department of Defense, the U.S. Department of Agriculture (USDA), the Department of Energy and the National Laboratories; with NIH intramural research laboratories; with state and local health departments; and with the private sector. Collaborations with National and Regional Biocontainment Laboratories (NBLs and RBLs) are also encouraged. As part of the planning process, the RCE leadership should determine and describe: which collaborations with institutions in their geographic region, and with other partners including foreign collaborations, will be further developed; target opportunities that can utilize the unique strengths within the consortium; and target opportunities that will address the goals of the NIAID Biodefense and EID research agenda.
c. Research Themes - The intent of the RCE Program is to support a substantial range of research, training and development activities, which utilize vibrant, novel, multi-disciplinary approaches that transcend customary thinking and organizational structures to address critical questions related to the eventual control of NIAID Category A-C Priority Pathogens and EID agents. Each RCE should have one or a limited number of themes, and it should be clear how synergy and collaboration will result from the themes. The themes and the range of activities being pursued should be clearly defined as a result of the strategic planning process. The proposed research projects and other activities should support and complement the theme areas. Themes may be organized around organisms, platforms, technologies, or other concepts. The relationship of the individual proposed activities to the themes should be clearly defined and explicitly stated.
d. Action Plan In this section, applicants must develop an Action Plan that outlines the major biodefense and emerging infectious diseases studies to be pursued with RCE funding; describe how these research efforts may facilitate vaccines, therapeutics, and/or diagnostics for NIAID Category A-C Priority Pathogens and EID agents; choose the highest priority opportunities; and develop a detailed research plan, with milestones, for the first year of funding and describe overall aims and milestones for subsequent years of funding. Elements of the Action Plan include: determining research projects that will be pursued and cores that will be established, maintained or expanded; defining milestones for specific products that the RCE proposes to pursue; establishing career development programs for new and existing faculty and research staff; and establishing overall policies and procedures for the management of cores and other Center resources. Specific thematic areas should emerge from the strategic planning process, and the Action Plan should elucidate how the RCE will capitalize on such programmatic themes.
e. Outcome Measurements - Each Center must describe in detail an Evaluation Plan to monitor and track the conduct and progress of activities performed in achieving its specific objectives and the objectives of the RCE Program. The application must include a detailed self-evaluation plan to assess achievement of the short- and long-term RCE goals. Since the major purpose of the evaluation is to provide information to assist each Center with program planning and management, the plan should address both the administrative and scientific functioning and accomplishments of the Center. While evaluation should be a continuous process, a formal evaluation by an outside, independent group selected by the Center’s leadership team and approved by NIAID staff should be conducted at least every two years. The Evaluation Plan should address the following areas of particular importance: training and recruitment; support for emergency response; translational activities; scope and impact of research; innovation and flexibility; collaboration and communication; integration and synergy; capacity and infrastructure; and funds management. The Evaluation Plan should include a description of how the evaluation will be conducted and include the principal measures and metrics to be used, as well as the potential sources of data. RCEs may also be called upon to gather data and participate in the development of a national RCE Program evaluation. Implementation of the Evaluation Plan is a responsibility of the Administrative Core.
f. Emergency Response Plan Implementing an Emergency Response Plan is a responsibility of the Administrative Core. While the Emergency Response Plan will vary from Center to Center, it is expected, at a minimum, that RCEs will: identify and establish communication lines with key biodefense and EID contacts in regional states and large cities; define possible roles for the RCE in the event of a biodefense or EID emergency in consultation with partners; identify the resources associated with the RCE that could contribute to efforts during an emergency; and educate Center researchers and other personnel about their role in this activity and about established response systems, such as the CDC Laboratory Response Network and regional organizations. Other efforts in this area are encouraged. One person within the RCE must be responsible for these efforts. The RCEs are expected to perform activities that would complement public health efforts and responsibilities, as appropriate, not duplicate these well-defined and established roles. RCEs may propose training activities that complement their Emergency Response Plan (see Career Development and Training below).
4. Administrative Core Each Center must propose an Administrative Core, which is responsible for managing, coordinating, and supervising the entire range of Center activities; monitoring progress; and ensuring that the Strategic Plan and its associated component plans are implemented. A well-developed Administrative Core is integral to the Center’s success, and should be clearly described in the application. The Principal Investigator must be director of the Administrative Core and must commit at least 25% effort to these responsibilities, in addition to his/her involvement in RCE research and/or other activities. In addition to the PI, it is recommended that each RCE have an Associate Director or Deputy PI for approximately 10% effort; this individual should have similar qualifications to the PI and be able to act in place of the PI if circumstances arise. The Administrative Core must include a Management Plan that identifies and discusses: the structure and roles of Administrative Core personnel; the Center leadership team (Steering Committee) responsible for each major RCE activity; the allocation and prioritization of fiscal and other resources; the facilitation of communications throughout the Center; and the structure and role of any major committees that will be instituted to help manage Center business. Organizational charts for the Administrative Core and the Center as a whole should be provided.
The Management Plan for the RCE must include procedures for continually evaluating and selecting the most promising research, with the ultimate goal of developing clinically useful biodefense vaccines, therapeutics, or diagnostics. It is expected that research projects with little potential will be discontinued and that new projects with greater potential will be initiated as the program evolves and matures. The addition, termination or major modification of projects will be reviewed and approved by NIAID program staff.
The Administrative Core director and staff are responsible for ensuring that all research activities are carried out in compliance with all federal and NIH regulations. The Administrative Core director and staff are also responsible for ensuring that appropriate systems are in place to provide for biosafety and security of materials, data, facilities and resources, including compliance with regard to Select Agent regulations. (Biosafety in Microbiology and Biomedical Laboratories (BMBL) Guidelines, Centers for Disease Control and Prevention and the National Institutes of Health, fifth Edition (http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm); U.S. Code of Federal Regulations 42 C.F.R. Part 73, 7 C.F.R. Part 331, and 9 C.F.R. Part 121 (http://www.cdc.gov/od/sap/)
Support for attendance at RCE and NIAID Biodefense Network meetings may be provided through the award as part of the Administrative Core travel budget.
B. Research Program
Each application must propose a Research Program that includes at least five (5) Research Projects, which together will enable the RCE to contribute significantly to the NIAID biodefense and emerging infectious diseases mission. The research projects must relate directly to the themes described above. The range of research topics that may be proposed is outlined above. Each Research Project may be similar in scope and design to a single-project (R01 type) Research Project Grant application, or it may be more extensive and resemble a multi-project (P01 type) Program Project Grant application that includes more than one related research project with more than one investigator. Collectively, the projects should support the RCE’s Strategic Plan and emphasize synergy and integration of overall themes. Each theme should have a lead investigator/coordinator who will monitor projects that relate to the theme and promote efforts that foster collaboration and synergy. Centers are expected to focus on and incorporate into the research projects state-of-the-art technology and approaches. Applicants are encouraged to carefully consider the scope and range of research proposed and develop a Research Program that is coherent overall and consistent with available resources and personnel. Research projects may be proposed for up to five years with budgets of at least $150,000 per project per year, direct costs; the Project Leader of each project must commit at least 10% effort to the project. Research projects that are unsuccessful or failing to achieve their goals should be phased out and replaced. The RCE leadership is responsible for having criteria and mechanisms to periodically assess productivity and success of research projects and for terminating those that do not meet their goals. These should be described in the Evaluation and Management Plans (above).
A portion of the research portfolio is expected to include translational research, which may lead to the eventual licensure of therapeutics, vaccines, and diagnostics against Category A-C Priority Pathogens and EID agents. Projects directed toward development of medical countermeasures that are effective against a variety of pathogens and toxins, technologies that can be widely applied to improve classes of products, and platforms that can reduce the time and cost of creating new products, are particularly encouraged. This broad spectrum strategy recognizes both the expanding range of biological threats and the limited resources available to address each individual threat. Translational projects must have a defined product development plan, with milestones and mechanisms for monitoring progress. This plan should include the participation of consultants with expertise in technology transfer and the development of regulated products. Only those projects for which the mechanism of action of the product is reasonably well understood, possible routes of administration and formulations suitable for scaleable production identified, and assays to assess product quality that are well developed, should be considered for support beyond Technology Readiness Level (TRL) 5 (http://www.hhs.gov/aspr/barda/documents/draft_trls_chem_mcm2007-08-06.pdf). In addition, animal models that are adequate to assess the ability of the product to induce a certain response and endpoints that will satisfy the Animal Rule (http://www.fda.gov/cber/rules/humeffic.htm) should be identified and included for products that may not be tested for efficacy in humans. Translational research projects should be designed to allow for submission of an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) by the end of the grant period.
Projects Proposing Clinical Trials
Applicants may propose small Phase 1 clinical trials to advance development of potential, diagnostics, therapeutics or vaccines for NIAID Category A-C Priority Pathogens and EID agents. The research plan for a clinical trial must be described in the form of a protocol synopsis, which must address the specific aspects described in Section IV.6. Methods of data analysis and sample size justification must be included. Submission of a detailed, final clinical protocol is neither required nor encouraged. A final clinical protocol will be developed and submitted prior to initiation of the study, as indicated in the NIAID Clinical Terms of Award. All clinical trials performed under awards made in response to this FOA must be in compliance with all federal regulations, guidance, and NIH policy, including the NIAID Clinical Terms of Award (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf).
For responsibilities associated with IND/IDE applications and sponsorship, the awardee is required to comply with NIH and FDA regulatory requirements for clinical monitoring and reporting and the protection of human subjects. See Section VI.2. - Cooperative Agreement Terms and Conditions of Award below.
Furthermore, as RCE supported research projects mature during the life of the project, particularly those geared toward the development of vaccines, therapeutics, and diagnostics, it may be appropriate to consider additional small Phase 1 clinical trials. Before proceeding, RCE researchers must discuss and seek approval for such trials with their respective RCE Steering Committee and NIAID RCE program staff so that appropriate activities may be initiated to plan, conduct, and monitor such studies in compliance with the NIAID Clinical Terms of Award (http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf). No clinical trials may be initiated or conducted through the RCE Program without the full participation and approval of NIAID and completion of all required documentation outlined in the NIAID Clinical Terms of Award and other federal regulations, guidance and NIH policy governing the conduct of clinical trials. Similar to those Phase I clinical trials proposed at the time of application, all Phase I clinical trials proposed during the project period must be conducted in existing clinical trial infrastructure, such as NIAID s Vaccine and Treatment Evaluation Units, the National Center for Research Resources Clinical and Translational Science Awards, or facilities already established and maintained by NIH or the RCE sponsoring institution, and approved by NIAID. RCE resources may not be used to develop or support clinical research infrastructure.
The proposed study must not exceed the clinical and scientific resources of the applicant’s team of institutions and must not exceed the funding period of the grant.
NOTE: Phase 2, 3, and/or 4 clinical trials will NOT be supported.
C. Scientific Facilities Cores
The RCE may include development and maintenance of core resources/facilities that are essential for the Center's success. Cores are intended to serve the needs of researchers associated with that region’s RCE, other NIAID-funded investigators from outside the Center, and other qualified investigators in the region; cores may not conduct research independent of specific projects that are supported in other ways. In addition to establishing new cores, cores may include resources that are currently available at the institution. The cores must facilitate and add value to the research and training activities, as well as create regional biodefense and EID capacity. The role the core will play in RCE activities and its value to the Center and the region must be clearly described and justified. If existing facilities are to be provided with RCE funds, the added value to the Center must be clearly described and justified. A detailed plan for ensuring that core facilities can be accessed in a timely way by RCE investigators and other investigators outside the Center but within the region must be provided. Additionally, plans for staffing, managing, and prioritizing use of the cores must be provided, as well as plans for determining fees to users if charging fees is necessary. Furthermore, cores must be available and integral to the RCE Emergency Response Plan. Cores whose sole mission is to support clinical research activities will not be supported; clinical research, where appropriate, will be supported as research projects. Similarly, sequencing, bioinformatics, and proteomics cores that duplicate resources already available through existing NIAID contracts will not be supported.
A necessary component of the Center's success will be the availability of adequate access to BSL3/4 biocontainment facilities. Applicants must describe in detail their research and training plans that will require high level containment facilities, and provide a description of facilities that are available currently or planned at the consortium institutions. A table listing each activity that requires BSL3/4 access and the likely facilities to be used should be included. If plans and arrangements have been made at the time of application with other planned or existing biocontainment facilities, such as NBLs or RBLs, these should be described. Where clearly justified and defined, funds to support Alterations and Renovations (A&R) to improve existing research laboratories or animal facilities may be requested.
D. Developmental Research Plan
Every RCE must identify and support Developmental Research Projects ( pilot projects) that take advantage of emergent technology and new research opportunities. These projects may involve scientists within the RCE or may extend to appropriate regional scientists outside the Center. The key purposes of this RCE activity are expanding the scope and range of research, investigators, and institutions involved in biodefense and EID research, allowing for testing of novel ideas (with little preliminary data), and developing new technologies. Developmental research projects that relate to the overall RCE themes are encouraged, and their selection by the RCE should include relevance to themes as a criterion.
Each RCE must submit a Developmental Research Plan that describes procedures for: soliciting applications for Developmental Research Projects from the region; selecting the most promising projects for funding, consistent with the Strategic Plan/themes and overall RCE Program goals; and monitoring success/productivity of the projects, including terminating them or promoting them to full project status. Solicitations must be open and publicly announced. Some Developmental Research Projects will begin during the first year, while others will be phased in during the duration of the award. The overall success of the RCE will, in part, be determined by the choice of Developmental Research Projects and their growth into independent research grants to advance specific vaccines, therapeutics, diagnostics or basic science studies. While the specific number of Developmental Research Projects to be supported is at the discretion of the RCE leadership, total funding for these projects may not exceed $600,000 direct costs in any one year. Developmental Research Projects are limited for one or two years, with a range of $100,000 to $125,000 per project per year, direct costs; the Project Leader must commit at least 10% effort. The plan for management of the funds associated with the Developmental Research Projects must be addressed in the application. Applicants may not submit in their application descriptions of projects that would be supported by Developmental Research Project funds; these will be selected and approved after award.
The use of Developmental Research Projects permits maximal flexibility to advance in directions that seem most scientifically fruitful; successful projects may also mature and replace full Research Projects that are no longer contributing significantly to the objectives of the RCE. As a result, the scientific members of the RCE may change during the course of the award.
E. Career Development and Training Programs
The RCE must include a consistent and significant commitment to career development and training, with the goal of increasing the availability of qualified researchers and other personnel for biodefense and EID research and furthering their career development. The training must be an integral part of the Strategic Plan and complement the research activities. Career Development plans that relate to the themes are strongly encouraged. The RCE budget may support the salary and research costs of candidates with outstanding potential, as well as other reasonable costs for other career development and training activities. The RCE is encouraged to invest in a variety of career development activities, including those focused on individuals and groups.
The application must include at least two distinct types of career development activities:
a. Individual Career Development Support Program- Career Development support for individuals may focus on advanced post-doctoral fellows, junior faculty, or established investigators. This may include mentored research experiences for current health professionals and faculty/staff interested in starting and pursuing research in the areas of biodefense and emerging infectious diseases. The program must require that each candidate have a mentor and devote at least 80% of his/her effort to the project. The description of individual career development activities should include the policies, criteria, and processes for selecting candidates and monitoring their progress, including special efforts to recruit qualified women and minorities. Individual Career Development Projects are not intended for pre-doctoral candidates, nor are they appropriate for post-doctoral fellows who have been in a laboratory for more than six years. Do not submit projects for specific individuals; these will be selected and approved after award. If career development projects for specific individuals are submitted, they will not be considered responsive and will not be reviewed. Rather, describe a plan for how such trainees would be solicited, how they would be selected, and how they would be monitored. Solicitations must be open and publicly announced. Support for individual Career Development Projects may not exceed three years. Because Career Development Projects will be of limited duration, studies that involve clinical trials are not appropriate unless directly associated with an on-going Research Project. Clinical research may be supported, where appropriate.
b. Group Career Development Activities - Other career development activities may be directed to groups of individuals; for example, there may be training programs for graduate students, technicians and others to learn specific skills, such as how to conduct research in Biosafety Level (BSL) 3/4 areas or to develop clinical research protocols. Other creative types of training are encouraged. If short-term training courses or similar activities are proposed, the application should describe the target audience, the curriculum, the faculty, and how participants will be recruited.
Career development projects and activities should include plans for evaluating success and for following the impact of the training on the careers of those who participate.
No more than $600,000 per year, direct costs, may be devoted to career development and training.
The NIAID supports a variety of training and career development opportunities, including various T, K, and F awards, and applicants are not to use the RCE to fund training that can be accomplished through other mechanisms. For additional information see the NIH Guide Notice NOT-AI-03-046 - BIODEFENSE RESEARCH TRAINING AND CAREER DEVELOPMENT OPPORTUNITIES (http://grants.nih.gov/grants/guide/notice-files/NOT-AI-03-046.html).
1. Mechanism(s) of Support
This Funding
Opportunity Announcement (FOA) will use the NIH (U54) cooperative agreement mechanism. The applicant
will be solely responsible for planning, directing, and executing the proposed
project.
This FOA uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see http://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the Initial Budget Period and the Entire Proposed Period of Support is to be submitted with the application.
The NIH U54 mechanism is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".
This FOA is a one-time solicitation. At this time, the NIAID has not determined whether or how this solicitation will be continued beyond the present FOA.
2. Funds Available
The NIAID intends to commit approximately $91 million dollars in FY 2009 to fund up
to 10 new and/or renewal grants in response to this FOA. An
applicant may request a project period of up to five years and a budget for direct costs up to $12 million dollars
per year.
Because
the nature and scope of the proposed research will vary from application to
application, it is anticipated that the size and duration of each award will
also vary. Awards in the range of $3 million to $12 million direct costs
per year are anticipated. Although the financial plans of the IC(s)
provide support for this program, awards pursuant to this funding opportunity
are contingent upon the availability of funds and the receipt of a sufficient
number of meritorious applications.
Facilities
and administrative costs requested by consortium participants are not included
in the direct cost limitation; see NOT-OD-05-004, November 2, 2004.
To ensure
that research aims can be met and biohazards can be contained, an applicant may
request up to $500,000 for significant Alterations and Renovations (A&R)
and/or up to $300,000 for major related equipment.
Section III. Eligibility Information
1. Eligible Applicants
1.A. Eligible
Institutions
You
may submit (an) application(s) if your organization has any of the following
characteristics:
A consortium of investigators, at more than one institution, who are working together to pursue basic and applied research and development activities with common themes that focus on countering the threat of NIAID Category A-C Priority Pathogens and EID agents, may apply. Applicant groups must be able to fully implement all of the required elements of a RCE. Applications may be submitted that include participants from more than one DHHS defined geographic region.
Foreign institutions/organizations are not eligible to apply as the primary applicant, but may enter into collaborations with a domestic institution/organization that is the primary applicant. Research projects may include foreign collaborations, but only if such collaborations are integral to a research project and only if the research project is lead by a Project Leader from a domestic institution. Foreign collaborations must be clearly justified, offer significant benefits that cannot be duplicated within the U.S., and may not exceed $100,000 per project per year, direct costs. Clinical trials at foreign sites will not be supported.
1.B.
Eligible Individuals
Any individual with the skills, knowledge, and resources
necessary to carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
An NIH
intramural scientist (IMS) may not serve as the Principal Investigator but may
participate as a member researcher of the RCE. The participation of an
IMS is independent of and unrelated to the responsibilities of the NIAID RCE
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.
2. Cost Sharing or Matching
Cost sharing, matching or cost participation
is not a requirement of this FOA.
The
most current Grants Policy Statement can be found at: (http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing)
3. Other-Special Eligibility Criteria
A
Principal Investigator may submit only one application and may serve as
Principal Investigator on only one application. A Principal Investigator
may serve as a collaborator on another application, provided there is no
scientific overlap.
An institution may submit only one application as the applicant institution, but may participate in other RCE applications. An institution may serve as the applicant institution on only one application.
Section IV. Application and Submission Information
1. Address to Request Application Information
The
PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
Telecommunications
for the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications
must be prepared using the most current PHS 398 research grant application
instructions and forms. Applications must have a D&B Data Universal
Numbering System (DUNS) number as the universal identifier when applying for
Federal grants or cooperative agreements. The D&B number can be obtained by
calling (866) 705-5711 or through the web site at (http://www.dnb.com/us/). The D&B number
should be entered on line 11 of the face page of the PHS 398 form.
The title and number
of this funding opportunity must be typed on line 2 of the face page of the
application form and the YES box must be checked.
Supplemental
Instructions for the Preparation of Multi-project Applications
The following section supplements the instructions found in the PHS Form 398 for preparing multi-project grant applications that will be submitted in paper format. Additional instructions are required because the PHS Form 398 is designed primarily for individual, free-standing research project grant applications, and has no specific instructions for multi-project applications consisting of research projects interrelated by a common theme.
All applications must be submitted on PHS Form 398. The multi-project grant application should be assembled and paginated as one complete document.
1. Form Page 1 - Face Page
Items 1 - 14: complete these items as instructed. This should be the first page of the entire application and all succeeding pages should be numbered consecutively.
2. Form Page 2
Using Form Page 2 of the PHS 398, provide a succinct but accurate description (abstract) of the OVERALL multi-project application addressing the major themes of the program. Do not exceed the space provided.
List the performance sites where the research will be conducted.
Under "Key Personnel", list the Principal Investigator of the multi-project application, the Deputy Principal Investigator, followed by the Project and Core Leaders of the component research projects and cores, other key personnel, and then other significant contributors.
3. Form Page 3 - Table of Contents
Do not use Form Page 3 of the PHS 398; a more comprehensive table of contents is needed for a multi-project application.
Bearing in mind that the application will be scientifically reviewed project-by-project and core-by-core, prepare a detailed Table of Contents that will enable reviewers to readily locate specific information pertinent to the overall application, as well as to each component research project and core. A page reference should be included for the budget for each project and each core. Further, each research project should be identified by number (e.g., Project 1), title, and Project Leader, and each Core should be identified by letter (e.g., Core A), title, and Core Leader. The page location of a COMPOSITE BUDGET should be indicated in the "Table of Contents."
4. Composite Budget
Do not use Form Page 4 of the PHS 398. Instead, using the suggested format presented below, prepare a composite budget for all proposed years of support. (Justification for budget elements should not be presented here but in the individual budgets of the projects and cores; present budgets in direct costs.)
SAMPLE: Consolidated Direct Cost Budget for All Proposed Years of Support
Component |
Year 1 |
Year 2 |
Year 3 |
Year 4 |
Year 5 |
All Years |
Project 1. Invest. |
125,000 |
130,000 |
135,200 |
140,608 |
146,232 |
677,040 |
Project 2. Study |
125,000 |
130,000 |
135,200 |
140,608 |
146,232 |
677,040 |
Project 3. Develop. |
100,000 |
104,000 |
108,160 |
112,486 |
116,985 |
541,631 |
Core A. Admin. Core. |
50,000 |
52,000 |
54,080 |
56,243 |
58,493 |
270,816 |
Core B. DNA |
25,000 |
50,000 |
52,000 |
54,080 |
56,243 |
237,323 |
Totals |
425,000 |
466,000 |
484,640 |
504,025 |
524,185 |
2,403,850 |
5. Form Page 5
Complete the Total Direct Cost line entries for all requested budget periods (years) and the Total Direct Cost for Entire Period of Support entry.
6. Biographical Sketch Format Page
Biographical sketches of the Principal Investigator and Deputy Principal Investigator should be placed after the Budget section for the entire application. Biographical sketches for Research Project and Core personnel should be placed with each corresponding individual Research Project and Core.
7. Other Support Format Page
Do not complete. (Any required information will be requested from successful applicants prior to grant award.)
8. Resources Format Page
Do not complete. Essential information is to be presented in the individual Research Project, Developmental Project, Career Development Projects and Core sections of the application.
9. Research Plan
The Research Plan must have the following five sections: (Note that face pages, biographical sketches, budget pages, literature citations, letters of support, checklists and other form pages are excluded from the page limits below.)
A. Background, Strategic Plan, and Management of the RCE (not to exceed 45 pages; this component will be weighted 30% in overall scoring)
1) Overview, to include:
2) Strategic Plan, to include:
3) Progress Report (for renewal applications only; not to exceed 10 pages; does not count toward the 45 page limit), to include:
4) Administrative Core, to include: A Cover Page (applicants may use the Face Page of the PHS 398 Form as a cover page for the Administrative Core); PHS Form Page 2; Biographical sketches of any personnel other that the PI and Deputy PI; Budget, using PHS 398 Form Pages 4 and 5, and budget justification; Literature Cited; Checklist; Discussion of the Administrative Core structure and function, roles and responsibilities of personnel, and Management Plan.
B. Research Program
Each application must include at least five Research Projects, which may include any combination of single-project (R01 type) and multi-project (P01 type) Research Projects. Each single-project Research Project has a 15-page limit [items A-D as defined in the PHS 398 instructions] and each multi-project (P01 type) Research Project has a 40-page limit. The maximum total limit for all Research Projects is 200 pages. Projects proposing small Phase 1 Clinical Trials are allowed an additional 15 pages for the Protocol Synopsis.
For each single-project Research Project include: a cover page; PHS Form Page 2; Budget pages (PHS 398 Form Pages 4 and 5) with budget justification; Biographical Sketches; Items A-D as defined in the PHS 398 instructions; Protection of Human Subjects from Research Risks; Vertebrate Animals; Select Agent Research/Biohazards; Literature Cited and Checklist.
For each multi-project Research Project include: an overview to the entire multi-project (text counts toward page limits, literature cited does not), and all budgets and budget justifications for the project (Form Pages 4 and 5 for each subproject, clearly labeled as to subproject, and a summary table for the overall project). For each subproject include: a cover page; PHS Form Page 2; Budget pages (PHS 398 Form Pages 4 and 5) with budget justification; Biographical Sketches; Items A-D as defined in the PHS 398 instructions; Protection of Human Subjects from Research Risks; Vertebrate Animals; Select Agent Research/Biohazards; Literature Cited
Do not use the Protection of Human Subjects from Research Risks section, vertebrate animals section, and select agent research/biohazard indications section to circumvent page limits, although the information contained in items E (Human Subjects) and F (Vertebrate Animals) and G (Select Agent Research) [defined in the PHS 398 form] must be included. The Research Projects and the Scientific Cores (below) together will count 55% in the overall score.
The specific instructions for formatting Research Projects are as follows:
Except for the requirements below, follow the PHS 398 Specific Instructions found at (http://grants1.nih.gov/grants/funding/phs398/phs398.doc - _Toc130797900) in preparing each research project.
1) Cover Page:
The Face Page of the PHS 398 Form should not be used as a cover page for projects within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual [project/core]. This Cover Page will demarcate each [project/core] and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page:
a. [Project/Core] Title: (e.g., A. Monoclonal Antibody Production Core)
b. Name of [Project/Core] Leader: (e.g., Smith, Robert A.)
c. Human Subjects (Yes or No)
If Yes, Exemption Number
(or)
IRB Approval Date (e.g., 5/14/06, or Pending)
(and)
Federalwide Assurance (FWA) number
d. Vertebrate Animals (Yes or No)
If Yes, IACUC Approval Date (e.g., 4/15/07, or Pending)
(and) Animal welfare assurance number
e. Proposed Period of Support
From: (mmddyy, e.g., 07/01/2007)
To: (mmddyy, e.g., 06/30/2012)
f. Costs Requested for Initial Budget Period
(e.g., Direct Costs: $50,000)
(e.g., Total Costs: $70,000)
g. Costs Requested for the Entire Budget Period
(e.g., Direct Costs: $212,323)
(e.g., Total Costs: $297,252)
h. Applicant Organization (full address)
2) Form Page 2: Provide a Description (abstract) of the research proposed in the project according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the Research Project will contribute towards attainment of the RCEs objectives.
List the performance sites where the research will be conducted.
Under "Key Personnel", list the Project Leader, followed by other key project personnel, and then other significant contributors.
3) Form Page 3: Prepare a Table of Contents for the Research Project using Form Page 3 of the PHS 398.
4) Biographical Sketches: Include the biographical sketches of the participating investigators for the Research Project.
5) Research Plan: Include items A-D as defined in the PHS 398 form, plus Protection of Human Subjects From Research Risks, Vertebrate Animals, Select Agent Research/Biohazards, and Literature Cited; see above for page limits.
7) Appendix: No appendix materials will be allowed for applications submitted in response to this FOA.
C. Scientific Facilities Cores
Individual scientific Cores may not exceed10 pages each (items A-D as defined in the PHS 398 instructions), with a maximum total limit for all cores of 50 pages.
Do not use the Protection of Human Subjects from Research Risks section, vertebrate animals section, and biohazard indications section to circumvent page limits, although the information contained in items E (Human Subjects) and F (Vertebrate Animals) and item G (Select Agent Research) [defined in the PHS 398 form] must be included.
The specific instructions for formatting Core units are as follows:
Except for the requirements below, follow the PHS 398 Specific Instructions found at (http://grants1.nih.gov/grants/funding/phs398/phs398.doc - _Toc130797900) in preparing each proposed core.
1) Cover Page:
The Face Page of the PHS 398 Form should not be used as a cover page for cores within a multi-project application. Instead, use the PHS 398 continuation page to create a "Cover Page" containing selected data about each individual [project/core]. This Cover Page will demarcate each [project/core] and should contain the following information items (these are a subset of the information provided on a PHS 398 Face Page:
a. [Project/Core] Title: (e.g., A. Monoclonal Antibody Production Core)
b. Name of [Project/Core] Leader: (e.g., Smith, Robert A.)
c. Human Subjects (Yes or No)
If Yes, Exemption Number
(or)
IRB Approval Date (e.g., 5/14/06, or Pending)
(and)
Federalwide Assurance (FWA) number
d. Vertebrate Animals (Yes or No)
If Yes, IACUC Approval Date (e.g., 4/15/07, or Pending)
(and) Animal welfare assurance number
e. Proposed Period of Support
From: (mmddyy, e.g., 07/01/2007)
To: (mmddyy, e.g., 06/30/2012)
f. Costs Requested for Initial Budget Period
(e.g., Direct Costs: $50,000)
(e.g., Total Costs: $70,000)
g. Costs Requested for the Entire Budget Period
(e.g., Direct Costs: $212,323)
(e.g., Total Costs: $297,252)
h. Applicant Organization (full address)
2) Form Page 2: Provide a Description (abstract) of the core activities and services according to the instructions on Form Page 2 of the PHS 398. In addition, the abstract should contain a brief description of how the core services will contribute towards attainment of the RCE’s objectives.
List the performance sites where the core activities and services will be conducted.
Under "Key Personnel", list the Core Leader, followed by other key core personnel, and then other significant contributors.
3) Form Page 3: Prepare a Table of Contents for the core using Form Page 3 of the PHS 398.
4) Biographical Sketches: Include the biographical sketches of participating investigators for the Core.
5) Core Plan: Include a description of the Core and its operations (items A-D as defined in the PHS 398 form), plus Protection of Human Subjects From Research Risks, Vertebrate Animals, Select Agent/Biohazards, and Literature Cited; see above for page limits.
7) Appendix: No appendix materials will be allowed for applications submitted in response to this FOA.
D. Developmental Research Plan
The Developmental Research Plan may not exceed 10 pages; this component will be weighted 5% in the overall score and must include: a cover page prepared as described above for project and core cover pages, PHS Form page 2, PHS Form Page 3. Budget pages (PHS 398 Form Pages 4 and 5; amounts requested under Other Expenses) with budget justification; Biographical Sketches; description of the plan for conducting the Developmental Research activities, including the solicitation, selection and monitoring processes (items A-D as defined in the PHS 398 form). DO NOT include any specific proposed Developmental Projects. This component will be weighted 5% in the overall score.
E. Career Development and Training Program
The Career Development and Training Program description may not exceed 10 pages each for the two required Career Development activities (Individual Career Development Support Program and Group Career Development Activities) (items A-D as defined in the PHS 398 form) with a maximum total limit of 30 pages for all Career Development Projects. For each project include: a cover page prepared as described above for project and core cover pages; PHS Form page 2, PHS Form Page 3, Budget pages (PHS 398 Form Pages 4 and 5) with budget justification; Biographical Sketches; description of the overall Career Development and Training Program, including plans for soliciting and selecting participants and conducting the program (items A-D as defined in the PHS 398 form). DO NOT include any proposed individual career development proposals. This component will be weighted 10% in the overall score.
10. Checklist
One Checklist, placed at the end of the application, is to be submitted for the entire application.
11. Appendix
No appendix materials will be allowed for applications submitted to this FOA.
3. Submission Dates and Times
Applications
must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.
3.A. Receipt, Review and Anticipated Start Dates
Letter
of Intent Receipt Date: May 3,
2008
Application
Receipt Date: June 3, 2008
Peer
Review Date: October, 2008
Council
Review Date(s): January 2009
Earliest
Anticipated Start Date: March, 2009
3.A.1. Letter of Intent
Prospective
applicants are asked to submit a letter of intent that includes the following
information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC 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:
Darren Sledjeski,
Ph.D.
Division
of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3131, MSC-7616
6700B Rockledge Drive
Bethesda , MD 20892-7616
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Telephone:
(301) 451-2638
FAX: (301) 480-2408
Email: SledjeskiD@niaid.nih.gov
3.B. Sending an
Application to the NIH
Applications
must be prepared using the research grant applications found in the PHS 398
instructions for preparing a research grant application. 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 (U.S. Postal Service Express or regular mail)
Bethesda,
MD 20817 (for express/courier service; non-USPS service)
Personal
deliveries of applications are no longer permitted (see (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
At
the time of submission, two additional copies of the application must be sent
to:
Although not required, to assist in the review of color figures, an
electronic copy on CD is also requested.
Darren
Sledjeski, Ph.D.
Division
of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3131, MSC-7616
6700B Rockledge Drive
Bethesda , MD 20892-7616
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Telephone: (301) 451-2638
FAX: (301) 480-2408
Email: SledjeskiD@niaid.nih.gov
Using the RFA Label: The RFA label available in the PHS
398 application instructions 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/labels.pdf).
3.C. Application
Processing
Applications
must be received on or before the application receipt date(s) described
above (Section IV.3.A.). If an application is
received after that date, it will be returned to the applicant without review.
Upon receipt, applications will be evaluated for completeness by the CSR and
responsiveness by the NIAID. Incomplete
and non-responsive applications will not be reviewed.
The
NIH will not accept any application in response to this funding opportunity
that is essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application. However, when a previously unfunded
application, originally submitted as an investigator-initiated application, is
to be submitted in response to a funding opportunity, it is to be prepared as a
NEW application. That is, the application for the funding opportunity must not
include an Introduction describing the changes and improvements made, and the
text must not be marked to indicate the changes from the previous unfunded
version of the application.
Information on the
status of an application should be checked by the Principal Investigator in the
eRA Commons at: (https://commons.era.nih.gov/commons/).
4. Intergovernmental Review
This
initiative is not subject to intergovernmental
review.
5. Funding Restrictions
All
NIH awards are subject to the terms and conditions, cost principles, and other
considerations described in the NIH Grants Policy Statement. The Grants Policy
Statement can be found at (http://grants.nih.gov/grants/policy/policy.htm).
Pre-Award
Costs are allowable. A grantee may, at its own risk and without NIH prior
approval, incur obligations and expenditures to cover costs up to 90 days
before the beginning date of the initial budget period of a new or competing
continuation award if such costs: are necessary to conduct the project, and
would be allowable under the grant, if awarded, without NIH prior approval. If
specific expenditures would otherwise require prior approval, the grantee must
obtain NIH approval before incurring the cost. NIH prior approval is required
for any costs to be incurred more than 90 days before the beginning date of the
initial budget period of a new or competing continuation award.
The incurrence of
pre-award costs in anticipation of a competing or non-competing award imposes
no obligation on NIH either to make the award or to increase the amount of the
approved budget if an award is made for less than the amount anticipated and is
inadequate to cover the pre-award costs incurred. NIH expects the grantee to be
fully aware that pre-award costs result in borrowing against future support and
that such borrowing must not impair the grantee's ability to accomplish the
project objectives in the approved time frame or in any way adversely affect
the conduct of the project. See NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm).
6. Other Submission
Requirements
a. Projects Proposing Phase 1 Clinical Trials
Protocol Synopsis:
Each clinical trial project must provide a protocol synopsis that addresses the following aspects of the proposed Phase 1 clinical trial: (Each protocol synopsis is limited to 15 pages, which will NOT count against the 200-page limit for all Research Projects per instructions given above.)
Study Title
Hypothesis to be tested
Study objectives
Population
Clinical sites
Intervention and comparators (if any)
Provision of investigational drugs and/or devices
Regimen
Study design, including:- Eligibility/exclusion criteria
- Randomization/stratification plan
- Number of subjects
- Anticipated duration of recruitment phase
- Total study duration
- Primary endpoints/outcomes
- Secondary endpoints/outcomes
- Study visit schedule and primary evaluations, including laboratory evaluations
- Sample size justification
- Any proposed sub-studies
- Statistical analyses and data analyses plan
- Data and safety monitoring plan
The protocol synopsis also must provide: 1) a plan for the management of the clinical trial that includes collection, storage, management, quality control, and reporting of study data and a system for adverse event and serious adverse event reporting; 2) a description of the procedures and timeline for protocol development and implementation, including preparation of the manual of operations; 3) a description of the assistance to be provided in the preparation of IND applications; 4) a plan for the recruitment and retention of study participants; and 5) plans for initial clinical site assessment and ongoing site monitoring. In addition, the application must describe the overall approaches to overcoming obstacles and limitations with respect to these activities.
Clinical trials at foreign sites will not be supported.
b. Projects Proposing Clinical Studies Involving the Use of Human Samples
For applications proposing a clinical study involving the use of human samples, such samples may be derived from clinical studies or clinical trials that are planned, ongoing or completed and sponsored by any source of support. Applications must include a detailed description of the proposed clinical study in the Research Plan section of the application, including: hypothesis, study objectives, study population, relevance of the proposed study to clinical disease/patient outcome, statistical design and analysis plan, plan for management and quality control of data, and plan for receipt and storage of human samples.
Documentation for the conduct of the proposed studies (written agreements, informed consent forms, complete clinical protocols, etc.) is not a required part of the application, but must be submitted to NIAID prior to the initiation of the study. See Section VI.2.A.5.
c. Appendix:
No appendix materials will be allowed for applications submitted to this FOA.
Plan
for Sharing Research Data
NIAID recognizes that the data and information generated through the
RCEs Program will be extremely valuable to other researchers and that the rapid
sharing of these data will be essential in advancing research to facilitate the
development of therapeutics, vaccines and diagnostics. Sharing of data
and information with the broad scientific community relies upon the RCEs making
such data and information available by depositing them into publicly accessible
data repositories. NIAID has established data release guidelines for
other programs, including the Centers of Excellence for Influenza Research and
Surveillance http://www3.niaid.nih.gov/research/resources/ceirs/ and the Microbial Sequencing Centers
http://www.niaid.nih.gov/dmid/genomes/mscs/default.htm.
Genomic sequences data sets generated with RCE funding are required to follow the NIAID Data Release and Usage Plan (http://www.niaid.nih.gov/dmid/genomes/mscs/data_release.htm), which provides for releasing sequence data within 45 calendar days of being generated to Genbank, a publicly searchable, international database of genetic sequences provided by the NIH National Center for Biotechnology and Information.
Other genome-wide or proteome-wide data sets generated by RCEs including, but not limited to, functional genomics, proteomics, metabolomics, glycomics data sets should be made available through a publicly accessible web site(s), such as one of the NIAID Bioinformatics Resource Center or other relevant sites as determined by the NIAID Program Officers; this must be done within 2 months of publication or within 1 year of generation, whichever comes first. Examples of genomics or proteomics data sets the RCEs should make available to the broad scientific community include annotation and functional characterization of genes and their products, gene and protein expression data, mass spectrometry data, siRNA data, SNPs and other genetic variation data, genotype and phenotype associations.
All applicants must include a plan for
sharing genomics, proteomics and other types of research data in their
application. Those responding to this funding opportunity announcement
must include a description of how such research data will be shared, or explain
why data sharing is not possible.
The
reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will
not factor the proposed data sharing plan into the determination of scientific
merit or the priority score.
Final details of the data release plan must be negotiated between NIAID and each RCE to assure that the planned data releases are consistent with the guiding principles stated above. Final approval for the data release plans will be given by NIAID prior to award. Updates to the Plan will have to be submitted to NIAID as part of the Annual Progress Report. The NIAID Program Staff will review the updated Plan for approval with modifications as needed.
It is recognized that each scientific project may pose specific
opportunities or challenges with respect to public data release.
Therefore efforts will be made to tailor the data release guidelines to
accommodate specific situations and needs as plans are negotiated between RCEs
and NIAID program staff.
Sharing Research
Resources
NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2003/index.htm)
and (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The
adequacy of the resources sharing plan and any related data sharing plans will
be considered by Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each
non-competing Grant Progress Report (PHS 2590, (http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting.
Section
V. Application Review Information
1. Criteria
The
following will be considered in making funding decisions:
If multiple applications from a single DHHS defined 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. The NIAID may also negotiate prior to award to modify the scope of the proposed research and other activities to meet overall program needs.
In addition to Scientific Merit, other criteria that will be used to make award decisions include:
2. Review and Selection Process
Applications
that are complete and responsive to the FOA will be evaluated for scientific
and technical merit by an appropriate peer review group convened by the NIAID in accordance with the review criteria
stated below.
As
part of the initial merit review, all applications will:
The goals of NIH supported research are to advance our
understanding of biological systems, to improve the control of disease, and to
enhance health. In their written critiques, reviewers will be asked to comment
on each of the following criteria in order to judge the likelihood that the
proposed research will have a substantial impact on the pursuit of these goals.
Each of these criteria will be addressed and considered in assigning the
overall score, weighting them as appropriate for each application. Note that an
application does not need to be strong in all categories to be judged likely to
have major scientific impact and thus deserve a high priority score. For
example, an investigator may propose to carry out important work that by its
nature is not innovative but is essential to move a field forward.
Significance: Does this
study address an important problem? If the aims of the application are
achieved, how will scientific knowledge or clinical practice be advanced? What
will be the effect of these studies on the concepts, methods, technologies,
treatments, services, or preventative interventions that drive this field?
Approach: Are the
conceptual or clinical framework, design, methods, and analyses adequately
developed, well integrated, well reasoned, and appropriate to the aims of the
project? Does the applicant acknowledge potential problem areas and consider
alternative tactics?
Innovation: Is the
project original and innovative? For example: Does the project challenge
existing paradigms or clinical practice; address an innovative hypothesis or
critical barrier to progress in the field? Does the project develop or employ
novel concepts, approaches, methodologies, tools, or technologies for this
area?
Investigators: Are the
investigators 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? Does the investigative team bring
complementary and integrated expertise to the project (if applicable)?
Environment: Does the
scientific environment in which the work will be done contribute to the
probability of success? Do the proposed studies benefit from unique features of
the scientific environment, or subject populations, or employ useful
collaborative arrangements? Is there evidence of institutional support?
Overall
Evaluation and Scoring:
In
addition to the five criteria indicated above, the evaluation of the overall
application will be based on the review and scientific merit of the individual
components; the overall synergy and integration of the components; the overall
program organization and capability of the associated personnel; and the extent
to which having a RCE would contribute to the global NIAID biodefense and EID
mission and achieve wide geographical distribution of Centers. A single
numerical priority score will be assigned to the whole application after
consideration of all of the review elements listed in this section of the
FOA.
The Background, Strategic Plan and Management of the RCE, the individual Research Projects, the Scientific Facilities Cores, the Developmental Research Plan as a whole, and the Career Development and Training Program as a whole, will each be assigned numerical priority scores. Each of these scores will contribute to the final overall score with the following weights given to the various components: Research Program and Scientific Facilities Cores, 55%; Background, Strategic Plan and Management of the RCE, 30%; Career Development and Training Program, 10%; and Developmental Research Plan, 5%.
Considerations for the Evaluation of Application Components:
Background, Strategic Plan, and Management of the RCE
Research Program
The following review criteria for Research Projects will be applied to each project in the context of how the project supports the Strategic Plan and advances the overall goals of the Center. In addition to the five criteria of Significance, Approach, Innovation, Investigators, and Environment, the following should be considered:
Scientific Facilities Cores
Developmental Research Plan
Career Development and Training Program
2.A.
Additional Review Criteria:
In
addition to the above criteria, the following items will continue to be
considered in the determination of scientific merit and the priority score:
Protection
of Human Subjects from Research Risk: The involvement of human subjects
and protections from research risk relating to their participation in the
proposed research will be assessed (see the Research Plan, Section E on Human
Subjects in the PHS Form 398).
Inclusion
of Women, Minorities and Children in Research: The
adequacy of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific goals of
the research will be assessed. Plans for the recruitment and retention of
subjects will also be evaluated (see the Research Plan, Section E on Human
Subjects in the PHS Form 398).
Care
and Use of Vertebrate Animals in Research: If
vertebrate animals are to be used in the project, the five items described
under Section F of the PHS Form 398 research grant application instructions
will be assessed.
Select Agent Research/Biohazards: If
materials or procedures are proposed that are potentially hazardous to research
personnel and/or the environment, determine if the proposed protection is
adequate.
2.B.
Additional Review Considerations
Budget: The reasonableness of the proposed
budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing
Research Data
Data Sharing Plan: The reasonableness of the data
sharing plan or the rationale for not sharing research data will be assessed by
the reviewers. However, reviewers will not factor the proposed data sharing
plan into the determination of scientific merit or the priority score. The
presence of a data sharing plan will be part of the terms and conditions of the
award. The funding organization will be responsible for monitoring the data
sharing policy. Program staff will be responsible for the administrative review
of the plan for sharing research data.
2.D. Sharing
Research Resources
NIH
policy expects that grant recipients make unique research resources readily
available for research purposes to qualified individuals within the scientific
community after publication (See the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr)
and (http://www.ott.nih.gov/policy/rt_guide_final.html). Investigators
responding to this funding opportunity should include a sharing research
resources plan addressing how unique research resources will be shared or
explain why sharing is not possible.
Program
staff will be responsible for the administrative review of the plan for sharing
research resources.
The
adequacy of the resources sharing plan will be considered by Program staff of
the funding organization when making recommendations about funding
applications. Program staff may negotiate modifications of the data and
resource sharing plans with the awardee before recommending funding of an
application. The final version of the data and resource sharing plans
negotiated by both will become a condition of the award of the grant. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590).
See Section VI.3. Reporting.
3. Anticipated Announcement and Award Dates
Not applicable.
Section VI. Award Administration Information
1. Award Notices
After
the peer review of the application is completed, the PD/PI will be able to
access his or her Summary Statement (written critique) via the eRA Commons.
If the application
is under consideration for funding, NIH will request "just-in-time"
information from the applicant. For details, applicants may refer to the NIH
Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards,
Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal
notification in the form of a Notice of Award (NoA) will be provided to
the applicant organization. The NoA signed by the grants management officer is
the authorizing document. Once all administrative and programmatic issues have
been resolved, the Notice of Award will be generated via email
notification from the awarding component to the grantee business official
(designated in item 14 on the Application Face Page). If a grantee is not email
enabled, a hard copy of the Notice of Award will be mailed to the business
official.
Selection of an
application for award is not an authorization to begin performance. Any costs
incurred before receipt of the NoA are at the recipient's risk. These costs may
be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.
2. Administrative and
National Policy Requirements
All NIH grant and cooperative agreement awards include the
NIH Grants Policy Statement as part of the Notice of Award. For these
terms of award, see the NIH Grants Policy Statement Part II: Terms and
Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
The
following Terms and Conditions will be incorporated into the award statement
and will be provided to the Principal Investigator as well as to the
appropriate institutional official, at the time of award.
2.A. Cooperative
Agreement Terms and Conditions of Award
The
following special terms of award are in addition to, and not in lieu of,
otherwise applicable OMB administrative guidelines, HHS grant administration
regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and
local Governments are eligible to apply), and other HHS, PHS, and NIH grant
administration policies.
The administrative
and funding instrument used for this program will be the cooperative agreement U54, an "assistance" mechanism
(rather than an "acquisition" mechanism), in which substantial NIH
programmatic involvement with the awardees is anticipated during the
performance of the activities. Under the cooperative agreement, the NIH purpose
is to support and stimulate the recipients' activities by involvement in and
otherwise working jointly with the award recipients in a partnership role; it
is not to assume direction, prime responsibility, or a dominant role in the
activities. Consistent with this concept, the dominant role and prime responsibility
resides with the awardees for the project as a whole, although specific tasks
and activities may be shared among the awardees and the NIH as defined below.
2.A.1. Principal
Investigator Rights and Responsibilities
The Principal Investigator will have the primary
responsibility for the following:
Highly Pathogenic Agents and/or Select Agents or Toxins (Agents)
The research proposed in this grant may involve Select Agents and/or Highly Pathogenic Agents.
NIAID defines a Highly Pathogenic Agent as an infectious Agent or Toxin that, under some circumstances, may warrant a biocontainment safety level of BSL3 or higher according to any one of the following sources:
If there is ambiguity in the BMBL guidelines and/or there is disagreement among the BMBL, an institutional committee or institutional official, the highest recommended containment level must be used.
At the beginning of each Progress Report clearly indicate:
Whether or not any research with a Highly Pathogenic Agent or Select Agent has been performed or is planned to be performed under this grant.
If yes, describe if your IBC or equivalent body or official has determined, for example, by conducting a risk assessment, that the work being planned or performed under this grant may be conducted at a biocontainment safety level that is lower than BSL3.
If the work involves Select Agents and/or Highly Pathogenic Agents. Also address the following points:
Any changes in the use of the Agent(s) or Toxin(s) that have resulted in a change in the required biocontainment level, and any resultant change in location, if applicable, as determined by your IBC or equivalent body or official.
If work with a new or additional Agent(s)/Toxin(s) is proposed in the upcoming project period, provide:
For domestic work with Select Agents provide documentation of Registration status of all domestic organizations/entities where Select Agent(s) will be used.
Please be advised that changes in the use of a Select Agent not previously described in the original application or last progress report will likely be considered a change in scope and, therefore, require NIH awarding office prior approval.
Consortium Plan
In order to promote discussion and early consensus among the RCE consortium participants regarding intellectual property (IP), data and management matters that may arise during RCE consortium projects, awardees are required to submit a Consortium Plan within six (6) months of the receipt of an award, and this requirement will be a term of award. While the specific terms of such a plan are left to the parties involved, NIAID recommends that the awardees consider the following points in the plan:
1) Measures to ensure the rapid utilization of inventions to benefit the public health through, inter alia, diligence in seeking patent protection for and licensing of new inventions when appropriate and the timely publication of research results.
2) Access by the RCE consortium participants to each others pre-existing IP rights to background technology (inventions, know-how, materials, information) required for performing RCE consortium projects through, for example, non-assertion clauses or cross-licenses.
3) Timely reporting to the NIH of U.S. Government-funded inventions in accordance with the Bayh-Dole Act, 35 U.S.C. 202, and the coordination of patent filing, patent licensing and IP management for these inventions (including addressing their use by other RCE consortium participants if necessary for performing the RCE consortium projects).
4) Ownership and management of inventions to include items, such as assignment of IP rights to employers, recognition of controlling U.S. law for U.S. Government-funded inventions and, for joint inventions, agreements that address licensing strategy and royalty sharing.
5) Exclusive/non-exclusive licensing option for commercial RCE consortium participants.
6) Notice of rights retained by the U.S. Government in inventions arising from federally funded RCE consortium projects.
7) Publication reporting and confidentiality to promote the preservation of patent filing rights.
8) Other technology transfer activities among the various RCE consortium participants, including but not limited to transfers of biological materials and other tangibles.
9) Disposition of IP rights and tangible materials at the expiration/termination of the RCE consortium and also upon the early departure of RCE consortium participants.
10) Sharing of research reagents and tools for research purposes among RCE consortium participants and with other parties in accordance with the NIH Principles and Guidelines on Biomedical Research Resources (http://ott.od.nih.gov/policy/RT_guide_final.html).
11) Coordination of IP/technology transfer matters between the technology transfer/legal offices and the grants/contracts/sponsored research offices of academic/non-profit RCE consortium participants.
12) Overall RCE consortium management and, for major RCE consortium projects that will utilize IP, tangible property and other resources of the RCE’s commercial participants (e.g., proprietary materials, trade secrets and other confidential information, personnel, budget, facilities/equipment, etc.), a management scheme that encourages the participation of those commercial participants.
13) A mechanism for resolving disputes among the RCE consortium participants.
14) Terms for the potential addition and departure of RCE consortium participants.
15) Legal liability of the RCE consortium participants.
Meetings
One determinant of success of the NIAID Biodefense Network will be the degree of communication among the participants. As such, the NIAID Biodefense Network will meet at least annually or as needed in the event of a biodefense or EID emergency event. The purpose of these meetings is to share scientific and programmatic information; to assess scientific progress; to identify new research and development opportunities and potential avenues of collaborations such as those with industry, private foundations, NIH intramural scientists, and other federal government agencies; and to establish priorities that will accelerate the translation of preclinical findings into clinical applications, reallocate resources and conduct other business of the RCE Program.
RCE Principal Investigators must attend and participate in the NIAID Biodefense Network meetings, as well as RCE meetings and teleconferences, to discuss progress and directions of research and to ensure that overall Program goals are being met. Principal Investigators must coordinate and participate in regular, local meetings of the RCE to discuss progress and directions of Center activities and to ensure that the necessary interdisciplinary interactions are taking place. Principal Investigators and appropriate other RCE investigators must attend an RCE Program Annual Scientific Meeting and participate as needed on teams to advance RCE Program business.
NIH Intramural Scientist Involvement
A collaborating NIH intramural scientist (IMS) may not receive salary, equipment, supplies, or other remuneration from this award. The IMS must obtain written approval of his/her Institute’s Scientific Director to allocate resources to the project. The letter of approval must specify that no more than $600,000 direct costs of intramural resources will be allocated to the project and provide assurance that the conduct of the project will comply with the DHHS regulations for research involving human subjects (if applicable) and with the PHS policy for vertebrate animal research, as well as other pertinent matters such as Select Agents.
If clinical research or clinical trials are conducted as a result of an award resulting from this FOA, NIAID policy requires that studies be monitored commensurate with the degree of potential risk to study subjects and the complexity of the study. An updated NIAID policy was published in the NIH Guide on July 8, 2002 and is available at: http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html. The full policy, including terms and conditions of award, is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.
All clinical research activities performed under this award must be in compliance with all U.S. Federal regulations, guidance and NIH, NIAID, and DMID policies applying to the conduct of research involving human subjects and regulatory application for new drug or biological licenses when applicable. These include, but are not limited to, U.S. Code of Federal Regulations (CFR) Title 21, Parts 11, 50, 54, 56, 312, 314, 601 and Title 45, Part 46; ICH E6 guidance for Good Clinical Practice (GCP); and NIH grants policy (refer to http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
For projects proposing clinical studies involving the use of human subjects samples, the following must be provided to NIAID prior to the initiation of the study:
1) Documentation of the ability to acquire human samples, including written agreements between the Principal Investigator and the institution, the clinical trial sponsor(s), including drug companies, if applicable, and the IND sponsor, if not one of the above, for the conduct of the proposed studies.
2) The complete clinical protocol and informed consent form(s) for the associated clinical study/trial from which samples will be obtained. NIH will treat as confidential any scientific, pre-clinical, clinical, or formulation data and information that the sponsor deems to be proprietary and confidential.
3) A draft consent form, where necessary, to obtain human samples not provided for in the associated clinical trial/study.
All clinical research activities performed outside of the U.S. must, in addition to U.S. Federal regulations, comply with the host country regulations for human subjects.
In addition, the Awardee must assure that all sites in the U.S. and outside the U.S. comply with the following:
1) Each institution engaged in human subjects research has a current, approved Federal-Wide Assurance Number on file with the DHHS Office for Human Research Protections (OHRP).
2) Each protocol and informed consent document is approved by the responsible Institutional Review Board (IRB)/Ethics Committee (EC) prior to subject entry.
3) Each study participant (or legal representative) will sign an IRB/EC-approved protocol consent prior to entry on study as part of the Informed Consent Process.
Clinical Research Responsibilities
For most clinical trials supported under this FOA, either NIAID or the organization supplying the investigational agent or device will serve as the IND/IDE sponsor. Under certain circumstances, NIAID and an awardee may mutually agree to have the PI serve as the IND/IDE sponsor. If NIAID holds the IND/IDE for clinical trials supported by this RFA, DMID will provide oversight on the development, assembly, and submission of all required regulatory documents, e.g., those regarding the use of investigational drugs, to the FDA or other applicable health authorities.
An NIAID Medical Officer will monitor the clinical trials and serve as the Medical Monitor. Should a pharmaceutical or biotechnology company sponsoring a clinical trial choose to name its own Medical Monitor, then the NIAID Medical Officer will work with the company-assigned Medical Monitor.
NIAID reserves the right to terminate or curtail the study (or an individual award) in the event of (a) failure to implement the study protocol, (b) a substantial shortfall in participant recruitment, follow-up, data reporting and dissemination, quality control, or other major breach of the protocol, (c) substantive changes in the agreed-upon protocol with which NIAID does not concur, (d) reaching a major study objective substantially before schedule with persuasive statistical evidence, or (e) human subject ethical issues that may dictate a premature termination.
2.A.2. NIH Responsibilities
An
NIH Project Scientist will have substantial programmatic involvement that is
above and beyond the normal stewardship role in awards, as described below.
The role
of NIH staff in the cooperative agreement is to support and encourage the
recipient's activities by substantial involvement as facilitators in the
process without assuming responsibilities that remain with the PI. The
NIAID RCE Program staff assigned to each RCE will work closely with the PI and
other RCE member scientists 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.
NIAID RCE Program staff will monitor the progress of the RCEs, helping coordinate research approaches among Centers, and contributing to the shaping of research projects or approaches as warranted. NIAID RCE Program staff will support and facilitate this process but not direct it. NIAID RCE Program staff 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 and EID research mission.
NIAID RCE Program staff will keep the RCEs informed about other ongoing studies supported by NIAID to avoid duplication of effort and encourage sharing/collaboration in the development of new clinically useful reagents and methodologies for biodefense and emerging infectious diseases research. NIAID RCE Program staff will coordinate access for the RCE to other NIAID resources, as well as assist the research efforts of the RCEs by facilitating access to fiscal and intellectual resources provided by industry, private foundations, NIH intramural scientists and other federal government agencies as appropriate.
NIAID RCE Program staff may assist, where warranted, in data
analyses and interpretation, and the dissemination of study findings to the
research community and health care recipients.
Additionally, a NIAID RCE Program Official
will be responsible for the normal scientific and programmatic stewardship of
the award and will be named in the award notice.
The assigned Program Official may also serve as the NIH Project Scientist.
2.A.3.
Collaborative Responsibilities
The NIAID
RCE Program office will provide overall coordination of the RCE Program.
NIAID RCE Program staff will work with the RCE Principal Investigators and hold
regular program-wide discussions to facilitate the program goals. Some RCEs may
develop common research interests; research focus groups may be formed to
pursue coordinated research activities.
RCE,
National Biocontainment Laboratory and Regional Biocontainment Laboratory
Principal Investigators, and NIAID RCE Program staff will be members of the
NIAID Biodefense Network. Additional NIAID Program Staff and scientists
other than RCE PIs may participate. The Network may be called upon to
make recommendations regarding approaches to specific threat agents and
emerging infectious diseases that require new attention, as the need
arises. The Network will also provide a forum for coordinating RCE
activities that require a liaison function with other federal agencies such as
the U.S. Food and Drug Administration (FDA), United States Department of
Agriculture (USDA), Department of Defense, and the Centers for Disease Control
(CDC). It will also facilitate mutually beneficial interactions between
the Centers and the Laboratories.
2.A.4. Arbitration
Process
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
For
purpose of arbitration, the NIAID Biodefense Network will serve in the capacity
as the Steering Committee.
3. Reporting
Awardees
will be required to submit the PHS Non-Competing Grant Progress Report, Form
2590 annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
Section VII. Agency Contacts
We encourage your inquiries concerning this funding
opportunity and welcome the opportunity to answer questions from potential
applicants. Inquiries may fall into three areas: scientific/research, peer
review, and financial or grants management issues:
1. Scientific/Research Contacts:
Written and telephone inquiries from potential applicants
to answer questions or clarify any issues about the RCE Program and this FOA
are welcome. Applicants are strongly encouraged to discuss their plans
with NIAID RCE Program staff to determine suitability.
Rona Hirschberg, Ph.D. (rhirschberg@niaid.nih.gov)
Susan Garges, Ph.D. (sgarges@niaid.nih.gov)
William Angus, Ph.D. (angusw@niaid.nih.gov)
Michael Schaefer, Ph.D. (mschaefer@niaid.nih.gov)
Division
of Microbiology and Infectious Diseases
National Institute of Allergy and Infections Diseases
Room
5007, MSC-6603
6610
Rockledge Drive
Bethesda, MD 20892-6003
Telephone
(301) 402-4197
Fax:
(301) 480-1263
2. Peer Review Contacts:
Darren Sledjeski, Ph.D.
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 3131, MSC-7616
6700B Rockledge Drive
Bethesda , MD 20892-7616
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Telephone:
(301) 451-2638
FAX: (301) 480-2408
Email: SledjeskiD@niaid.nih.gov
3. Financial or Grants Management Contacts:
Theresa Mercogliano
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2124, MSC-7610
6700B Rockledge Drive
Bethesda, MD 20892-7610
Telephone: (301) 402-5512
FAX: (301) 480-3780
Email: tmercoglia@mail.nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in Research:
Recipients
of PHS support for activities involving live, vertebrate animals must comply
with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
Human Subjects Protection:
Federal
regulations (45CFR46) require that applications and proposals involving human
subjects must be evaluated with reference to the risks to the subjects, the
adequacy of protection against these risks, the potential benefits of the
research to the subjects and others, and the importance of the knowledge gained
or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
Data and Safety Monitoring Plan:
Data
and safety monitoring is required for all types of clinical trials, including
physiologic toxicity and dose-finding studies (Phase 1); efficacy studies
(Phase 2); efficacy, effectiveness and comparative trials (Phase 3). Monitoring
should be commensurate with risk. The establishment of data and safety
monitoring boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, (http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research Data:
Investigators
submitting an NIH application seeking $500,000 or more in direct costs in any
single year are expected to include a plan for data sharing or state why this
is not possible (http://grants.nih.gov/grants/policy/data_sharing).
Investigators should
seek guidance from their institutions, on issues related to institutional
policies and local IRB rules, as well as local, State and Federal laws and
regulations, including the Privacy Rule. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
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 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 funding opportunity 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.
Sharing of Model Organisms:
NIH
is committed to support efforts that encourage sharing of important research
resources including the sharing of model organisms for biomedical research (see
(http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement (http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
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 "NIH Guidelines for Inclusion of Women and Minorities as
Subjects in Clinical Research (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is 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 Clinical Research:
The
NIH maintains a policy that children (i.e., individuals under the age of 21)
must be included in all clinical research, conducted or supported by the NIH,
unless there are scientific and ethical reasons not to include them.
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 (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 applications for research involving human
subjects and individuals designated as key personnel. The policy is available
at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html).
Human Embryonic Stem Cells (hESC):
Criteria
for federal funding of research on hESCs can be found at (http://stemcells.nih.gov/index.asp)
and at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html).
Only research using hESC lines that are registered in the NIH Human Embryonic
Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, the official NIH identifier(s) for the hESC line(s)
to be used in the proposed research. Applications that do not provide this
information will be returned without review.
NIH Public Access Policy:
NIH-funded
investigators are requested to submit to the NIH manuscript submission (NIHMS)
system (http://www.nihms.nih.gov) at
PubMed Central (PMC) an electronic version of the author's final manuscript
upon acceptance for publication, resulting from research supported in whole or
in part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH
is requesting that authors submit manuscripts resulting from 1) currently
funded NIH research projects or 2) previously supported NIH research projects
if they are accepted for publication on or after May 2, 2005. The NIH Public
Access Policy applies to all research grant and career development award
mechanisms, cooperative agreements, contracts, Institutional and Individual
Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural
research studies. The Policy applies to peer-reviewed, original research
publications that have been supported in whole or in part with direct costs
from NIH, but it does not apply to book chapters, editorials, reviews, or
conference proceedings. Publications resulting from non-NIH-supported research
projects should not be submitted.
For
more information about the Policy or the submission process please visit the
NIH Public Access Policy Web site at (http://publicaccess.nih.gov/) and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_manual.htm).
Standards for Privacy of Individually Identifiable Health Information:
The
Department of Health and Human Services (DHHS) issued final modification to the
"Standards for Privacy of Individually Identifiable Health
Information", the "Privacy Rule", on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance Portability and
Accountability Act (HIPAA) of 1996 that governs the protection of individually
identifiable health information, and is administered and enforced by the DHHS
Office for Civil Rights (OCR).
Decisions about
applicability and implementation of the Privacy Rule reside with the researcher
and his/her institution. The OCR website (http://www.hhs.gov/ocr/)
provides information on the Privacy Rule, including a complete Regulation Text
and a set of decision tools on "Am I a covered entity?" Information
on the impact of the HIPAA Privacy Rule on NIH processes involving the review,
funding, and progress monitoring of grants, cooperative agreements, and
research contracts can be found at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html).
URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within
specified page limitations. For publications listed in the appendix and/or
Progress report, internet addresses (URLs) must be used for publicly accessible on-line journal articles. Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide
any other information necessary for 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 FOA 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 at (http://www.cfda.gov/)
in the following citation: No. 93.856, Microbiology and Infectious Diseases
Research, and is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review. Awards are made under
the authorization of Sections 301 and 405 of the Public Health Service Act as
amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR
Parts 74 and 92. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at (http://grants.nih.gov/grants/policy/policy.htm).
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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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