and Human Services (HHS)
EXPIRED
REGIONAL CENTERS OF EXCELLENCE FOR BIODEFENSE AND EMERGING INFECTIOUS
DISEASES RESEARCH
RELEASE DATE: April 1, 2004
RFA Number: RFA-AI-04-018 (Reissued as RFA-AI-08-002)
(see NOT-AI-04-026)
EXPIRATION DATE: September 10, 2004
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENT OF PARTICIPATING ORGANIZATION:
National Institute of Allergy and Infectious Diseases (NIAID)
(http://www.niaid.nih.gov)
CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBERS:
No. 93.855, Immunology, Allergy, and Transplantation Research
No. 93.856, Microbiology and Infectious Diseases Research
LETTER OF INTENT RECEIPT DATE: August 9, 2004
APPLICATION RECEIPT DATE: September 9, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute of Allergy and Infectious Diseases (NIAID) is
expanding the Regional Centers of Excellence for Biodefense and Emerging
Infectious Diseases Research (RCE) program. The overall goal of the RCE
Program is development and maintenance of a strong infrastructure and
multifaceted research and development activities that will provide the
scientific information and translational research capacity that will lead to
the next generation of therapeutics, vaccines and diagnostics against the
NIAID Category A-C Agents
(http://www.niaid.nih.gov/biodefense/bandc_priority.htm). To realize this
goal, the Centers will be provided with support to: 1) develop and conduct
programs of investigator-directed research; 2) train researchers and other
personnel for biodefense and emerging infectious diseases research
activities; 3) develop and maintain comprehensive core facilities that
support the research and training activities of the RCE and make these
available to qualified investigators from academia, biotechnology companies,
the pharmaceutical industry, and other appropriate entities in the geographic
region; 4) develop translational research capacity for testing and validating
vaccine, therapeutic and diagnostic concepts for biodefense and emerging
infectious diseases; and 5) be prepared and available to provide facilities
and scientific support to first-line responders in the event of a national
biodefense emergency.
This Request for Applications (RFA) invites research institutions and groups
of investigators to form consortia and develop new applications for research
programs which address the fundamental research and development questions
expected to yield the information required to counter the threat of
bioterrorism. Diverse research and development approaches are encouraged as
long as they include the following essential features: a research focus on
NIAID Category A-C agents including the incorporation of a translational
component with the long term goal of developing products for human use.
Additionally, consortia must document: institutional commitment;
organizational capabilities; ability to develop and expand facilities; plans
for training investigators and other participants in the national biodefense
effort; and interdisciplinary coordination and collaboration, particularly
linkages to federal, state, and local agencies as well as the private sector.
Consortia must have a lead team of individuals responsible for the overall
management and direction of the RCE. A group of Center member researchers,
with expertise in biodefense and emerging infectious diseases, is required to
lead the research thrust which underlies all activities of the RCE. Centers
should emphasize the use of cutting-edge approaches and technologies.
To ensure that the RCE program contributes maximally and effectively to the
NIAID biodefense and emerging infectious diseases effort, the overall
direction and scope of activities of the Program and its participant Center
sites will be centrally coordinated and monitored by the NIAID Biodefense
Network. The Network, which is operated through the RCE Program Office at
NIAID, includes the RCE Program Staff, RCE Principal Investigators, and the
Principal Investigators of the National Biocontainment and Regional
Biocontainment Laboratories
(http://www.niaid.nih.gov/newsroom/releases/nblscorrect21.htm)
To achieve nationwide distribution of the RCEs, the NIAID will use the 10
established DHHS regions:
REGION I: CT, ME, MA, NH, RI, VT
REGION II: NJ, NY, PR, VI
REGION III: DE, D.C., MD, PA, VA, WV
REGION IV: KY, MS NC, TN, AL, FL, GA, SC
REGION V: IL, IN, MI, MN, OH, WI
REGION VI: AR, LA, NM, OK, TX
REGION VII: IA, KS, MO, NE
REGION VIII: CO, MT, ND, SD, UT, WY
REGION IX: AZ, CA, HI, NV, and the six U.S. Associated Pacific jurisdictions
REGION X: AK, ID, OR, WA
It is the long-range goal of this program, contingent upon the availability
of funds, to establish at least one RCE within each region. NIAID encourages
applications from all regions of the country, particularly those that do not
have existing RCEs. Applicants from regions with currently funded RCEs
should address the additional value of having another Center in the region
and how the proposed activities would relate to those ongoing at the
established RCE. Although preference is to establish RCEs in those regions
that currently do not have one, it is only one of several factors that will
be considered in making funding decisions.
PUBLIC BRIEFING
An informational session for investigators representing groups considering
submission of applications in response to this RFA will be held. Details of
the meeting will be announced on the NIAID biodefense website
(http://www.niaid.nih.gov/biodefense/research/rce.htm) and in the NIH Guide
to Grants and Contracts. Representatives from the RCE program and from the
NIAID Division of Extramural Activities will provide information and answer
questions pertinent to preparing applications in response to this RFA.
RESEARCH OBJECTIVES
Background
As identified by the NIAID Blue Ribbon Panel on Bioterrorism and Its
Implications for Biomedical Research and subsequently the NIAID Category A
and Category B and C Research Agendas, there is a critical need for the
establishment of a highly organized and comprehensive research and
development infrastructure with strong translational research capacity
(http://www.niaid.nih.gov/biodefense). To achieve this goal, the NIAID
established the Regional Centers of Excellence for Biodefense and Emerging
Infectious Diseases Research (RCE) Program and is expanding it with this RFA.
Each Center serves a geographical region and is composed of investigators at
several participating universities and/or research institutions, including
government and the private sector. The mission of the Centers is research
and other activities related to biodefense and emerging infectious diseases.
The Centers member researchers are encouraged to collaborate with other NIH-
funded investigators within and outside the Center region. In addition, the
Centers serve as a focal point to organize and promote relationships with:
pharmaceutical and biotechnology companies; federal, state, and local
agencies; and other qualified investigators to foster translational research
and promote maximal use of the core facilities by a broad range of qualified
scientists. In times of a national biodefense emergency, the RCEs will be
expected to rapidly realign their activities to assist response efforts
within their region. This includes making their core facilities and other
resources available to assist in the implementation of national biodefense
plans.
Objective and Scope
This initiative supports the expansion of the Regional Centers of Excellence
for Biodefense and Emerging Infectious Diseases Research (RCE) for the
purpose of developing and maintaining research and development capacity that
is needed to assess and counter bioterrorism or emerging infectious disease
threats. To accomplish this, the Centers will receive support to: 1) develop
and conduct programs of investigator-directed research; 2) train researchers
and other personnel for biodefense and emerging infectious diseases research
activities; 3) develop and maintain comprehensive core facilities that
support the research and training activities of the RCE and make them
available to qualified investigators from academia, biotechnology companies,
the pharmaceutical industry, and other appropriate entities in the geographic
region; 4) develop translational research capacity for testing and validating
vaccine, therapeutic and diagnostic concepts for biodefense and emerging
infectious diseases; and 5) be prepared and available to provide facilities
and scientific support to first-line responders in the event of a national
biodefense emergency.
The scope of acceptable areas of investigation includes research ranging from
basic, to the basic/clinical interface, to clinical investigations, spanning
the range of studies needed to establish a comprehensive national program for
the NIAID Category A-C agents. While small proof-of-concept Phase I or Phase
I/II clinical trials are encouraged, large Phase II or III clinical studies
are beyond the scope of this program and will not be supported. A list of
research areas that are considered relevant for the purposes of this RFA
follows. This list is not all-inclusive, and prospective applicants are
encouraged to discuss program relevance issues with NIAID program staff
listed under INQUIRIES. At this time, studies on Bacillus anthracis and
orthopox viruses are well represented within the NIAID research portfolio,
and investigators are encouraged to focus on other Category A agents and the
Category B and C agents unless presenting novel concepts relating to B.
anthracis and orthopoxviruses.
Research areas relevant to this RFA:
o Basic biology of less well studied Category A-C agents.
o Mechanisms of pathogenesis, with emphasis on the less well studied agents.
o Application of genomic and proteomic strategies.
o Basic aspects of the innate and adaptive immune responses.
o Rapid, sensitive, and specific approaches for agent detection and
identification for use in a clinical setting.
o Target identification for diagnostics, therapeutics, and vaccines,
including assay development.
o Development of new animal models for pathogenesis studies, for
therapeutics and vaccine evaluation, and for rapid diagnostic studies.
o Preclinical studies to facilitate translation of research findings into
clinical interventions.
o Testing through proof-of-concept Phase I or Phase I/II clinical trials of
drugs, diagnostics and vaccines.
For a more detailed list of the NIAID biodefense research priorities,
applicants are encouraged to consult the strategic plan and research agendas
(http://www.niaid.nih.gov/biodefense/research/strat_plan.htm)
Minimum Requirements for the Research Plan
1. Background, Strategic Plan and Management of the RCE
In this section, identify and describe the overall goals and objectives of
the RCE, the organizational structure of the proposed Center, participating
institutions/organizations, and the role of all consortium members.
As part of the application preparation process, the consortium organizers
must undertake the development of a strategic plan, and provide a
chronological review of planning and priority- setting processes. The
purpose of the strategic plan is to identify unique opportunities for the RCE
to contribute to biodefense and emerging infectious diseases research, as
well as identify unmet needs that may be addressed by the planned RCE
resources. The plan must include both short- and long-term goals, and must
include descriptions of objective milestones that will be used to measure
progress. The following framework is suggested for developing the strategic
plan:
o Strengths - Identify and describe the strengths of the proposed consortium
including a brief summary of the research and development experience and
expertise of RCE participants as well as the current facilities and other
research resources available.
o Opportunities - Identify and evaluate the potential opportunities to
establish high quality research, training and development programs using RCE
funds. RCEs are encouraged to form associations with other federal agencies,
such as: the Centers for Disease Control and Prevention (CDC), the
Department of Defense, the U.S. Department of Agriculture (USDA), and the
Department of Energy and the National Laboratories; with NIH intramural
research laboratories; with state and local health departments; and with the
private sector. As part of the planning process, the RCE leadership should:
determine which collaborations with the institutions in their geographic
region will be further developed; target opportunities that can utilize the
unique strengths within the consortium; and target opportunities that will
address the goals of the NIAID Biodefense Research Agenda.
o Research Theme - The intent of the RCE Program is to support a substantial
range of research, training and development activities that involve vibrant,
multi-disciplinary approaches that transcend customary thinking and
organizational structures to address critical questions related to the
control of NIAID Category A-C Agents. The theme and the range of activities
being pursued should be clearly defined as a result of the strategic planning
process.
o Action Plan - Outline the major biodefense and emerging infectious diseases
studies to be assisted by RCE funding and describe how these research efforts
will translate into vaccines, therapeutics and/or diagnostics for NIAID
Category A- C agents. Choose the highest priority opportunities and develop a
detailed research plan, with milestones, for the first year of funding and
describe overall aims and milestones for subsequent years of funding.
Elements of the action plan include: determining what research projects will
be pursued and which cores will be established or expanded; identifying
possible pilot projects for support as developmental research projects;
defining milestones for specific products that the RCE proposes to pursue;
establishing career development programs for new and existing faculty and
research staff; establishing policies and procedures for access to and
handling of NIAID Category A-C agents; and establishing overall policies and
procedures for the management of cores and other Center resources. Specific
thematic areas should emerge from the strategic planning process, and the
action plan should elucidate how the RCE will capitalize on such programmatic
themes.
o Outcome Measurements - Determine and describe how progress on the action
plan will be measured. Include qualitative and quantitative criteria for
measuring how the RCE provides "added value" and for assessing the unique
contributions of the Center that cannot be provided by other research awards.
Define metrics for assessing long-term goals for the entire funding period,
and specific, detailed milestones with timelines for the first year for each
project and activity.
o Emergency Response Plan Implementing an Emergency Response Plan is a
responsibility within the Administrative Core and should be described in this
section. While the emergency response plan may vary from Center to Center,
it is expected that RCEs will: identify and establish communication lines
with key biodefense contacts in regional states and large cities; define
possible roles for the RCE in the event of a biodefense emergency in
consultation with partners; identify the resources associated with the RCE
that could contribute to efforts during an emergency; and educate Center
researchers and other personnel about their role in this activity and about
established response systems such as the CDC Laboratory Response Network and
regional organizations. The RCEs are expected to perform activities that
would complement public health efforts and responsibilities, as appropriate,
not duplicate these well-defined and established roles.
o Administrative Core - The Administrative Core director and staff are
responsible for managing, coordinating, and supervising the entire range of
Center activities, monitoring progress and ensuring that the strategic plan
is implemented. A well-developed Administrative Core is integral to the
Center’s success and should be clearly defined in the application. The
Principal Investigator must be director of the Administrative Core and must
commit at least 25% effort to these responsibilities, in addition to his/her
own RCE research and other activities. The management plan should include:
the structure and roles of Administrative Core personnel; who among the
Center leadership team is responsible for each major RCE activity; how fiscal
and other resources will be allocated and prioritized; how communications
throughout the Center will be facilitated; and the structure and role of any
major committees that will be instituted to help manage Center business.
Organizational charts for the Administrative Core and the Center as a whole
should be provided. The Administrative Core director and staff are
responsible for ensuring that sure appropriate systems are in place to
provide for biosafety and security of materials, data and facilities,
including compliance with regard to select agent regulations. Institutions
must be in compliance with U.S. laws and regulations and DHHS and NIH
policies in effect at the time of grant award and during the period of
performance of the research. The management plan for the RCE must include
procedures for continually evaluating and selecting the most promising
research, with the ultimate goal of developing clinically useful biodefense
and emerging infectious diseases vaccines, therapeutics or diagnostics. It is
expected that research projects with little translational potential will be
discontinued and that new projects with greater potential will be initiated
as the program evolves and matures. The support for attendance at NIAID
Biodefense Network meetings can be provided through the award as part of the
administrative core travel budget.
2. Research Program
Each application must propose a Research Program that includes at least five
(5) Research Projects, which together will enable the RCE to contribute
significantly to the NIAID biodefense and emerging infectious diseases
mission. The range of research topics that may be proposed is outlined
above. A project may be similar in scope and design to a Research Project
Grant (R01), or it may be more extensive and resemble a Program Project Grant
(P01) and include more than one related research project with more than one
investigator. Collectively, the projects should support the strategic plan
and emphasize synergy and integration of overall themes. Centers are
expected to focus on and incorporate into the research projects state-of-the-
art technology and approaches. Each research project must include measurable
milestones, with timelines, and criteria for assessing success/productivity
at periodic intervals. Applicants are encouraged to carefully consider the
scope and range of research proposed and develop a Research Program that is
coherent overall and consistent with available resources and personnel.
3. Scientific Facilities Cores - The RCE plan must include development and
maintenance of core resources/facilities that are essential for the Center's
success. Cores may include resources that are currently available at the
institution, as well as new or expanded ones. The cores must facilitate and
add value to the research and training activities, as well as create new
regional biodefense capacity. The role the cores will play in RCE activities
and their value to the Center and the region must be clearly described. If
existing facilities are to be provided with RCE funds, the added value to the
Center must be clearly described and justified. A detailed plan for ensuring
that core facilities can be accessed in a timely way by RCE investigators,
other NIAID-funded investigators from outside the Center, and other qualified
investigators in the region must be provided. Plans for staffing, managing,
and prioritizing use of the cores must be provided, as well as plans for
determining fees to users. In addition, cores must be available and integral
to the RCE emergency response plan.
A necessary component of the Center's success will be the availability of
adequate access to BSL3/4 biocontainment facilities. Applicants must
describe in detail their research and training plans that will require high
level containment facilities, and in this component, provide a description of
facilities that are available currently or planned at the consortium
institutions. A table listing each activity that requires BSL3/4 access and
the likely facilities to be used must be included. If plans and arrangements
have been made at the time of application with other planned or existing
biocontainment facilities, these should be described.
4. Developmental Research Plan
Every RCE must identify and support Developmental Research Projects ( pilot
projects) that take advantage of emergent technology and new research
opportunities. These projects may involve scientists within the RCE or
extend to appropriate regional scientists outside the Center. Key purposes
of this RCE activity are expanding the scope and range of research,
investigators, and institutions involved in biodefense and emerging
infectious diseases research and allowing for testing of novel ideas (with
little preliminary data) and new technologies.
The Developmental Research Plan must describe processes for: soliciting
applications for Developmental Research Projects from the region; selecting
the most promising projects for funding, consistent with the strategic plan
and the overall RCE Program goals; and monitoring success/productivity of the
projects, including terminating or promoting them to full Research Project
status. Some Developmental Research Projects will begin during the first
year, while others will be phased in during the life of the award. The
overall success of the RCE will, in part, be determined by the choice of
Developmental Research Projects and their growth into new NIH investigator-
initiated research grants to advance specific vaccines, therapeutics,
diagnostics or basic science studies. While the specific number of
Developmental Projects to be supported is at the discretion of the applicant,
total funding for these projects may not exceed $600,000 direct costs in any
one year, with no more than $100,000 for any one study. The plan for
management of the funds associated with the developmental projects must be
addressed in the application. These funds are intended to remain flexible
and support studies lasting no more than two years. Applicants should not
submit detailed descriptions of projects that would be supported by
Developmental Research funds; these will be selected and approved after
funding.
The use of Developmental Research Projects permits maximal flexibility to
advance in the directions that seem most scientifically fruitful; successful
pilot projects may also mature and replace full Research Projects that are no
longer contributing significantly to the objectives of the RCE. As a
result, the scientific members of the RCE may change during the course of the
award.
5. Career Development and Training Programs
The RCE must include a consistent and significant commitment to career
development and training, with the goal of increasing the availability of
qualified researchers and other personnel for biodefense and furthering their
career development. The training must be an integral part of the strategic
plan, and complement the research activities. The RCE budget should support
the salary and research costs of candidates with outstanding potential, as
well as other reasonable costs for career development and training
activities. Each application should include at least two (2) career
development projects and it is recommended that one be focused on basic
research and the other on translational/clinical activities; others may be
added at the discretion of the consortium leadership.
Career Development Projects for individuals may focus on advanced post-
doctoral candidates, junior faculty, or established investigators who wish to
develop or refocus their careers on biodefense and emerging infectious
diseases research, as well as technical support staff. This may include
mentored research experiences for current health professionals and
faculty/staff interested in starting and pursuing research in the areas of
biodefense and emerging infectious diseases. Each candidate must have a
mentor and devote at least 80% of his/her effort to biodefense/emerging
infectious diseases research. The description of these plans should include
the policies, criteria, and processes for selecting candidates and monitoring
their progress, including special efforts to recruit qualified women and
minorities. Career Development Projects are not intended for pre-doctoral
candidates.
Other career development activities may be directed to groups of individuals;
for example, there may be training programs for graduate students,
technicians and others to learn specific skills, such as how to work in
Biosafety Level (BSL) 3/4 areas or develop clinical research protocols.
Other creative types of training are encouraged. If short-term training
courses or similar activities are proposed, the application should describe
the target audience, the curriculum, the faculty, and how participants will
be recruited.
Because Career Development Projects will generally be for less than two years
in duration, studies which involve interventional clinical trials are not
viewed as appropriate for the scope of this activity unless clearly
associated with an on-going Research Project. Both types of career
development projects should include plans for evaluating success and for
following the impact of the training on the careers of the participating
trainees.
The NIAID supports a variety of training and career development
opportunities, including various T, K, and F awards, and applicants are not
to use the RCE to fund training that can be accomplished through other
mechanisms. For additional information see NIH Guide Notice NOT-AI-03-046 -
BIODEFENSE RESEARCH TRAINING AND CAREER DEVELOPMENT OPPORTUNITIES
(http://grants.nih.gov/grants/guide/notice-files/NOT-AI-03-046.html).
MECHANISM OF SUPPORT
This RFA will use the NIH cooperative centers agreement (U54) award. Under
this mechanism, the Principal Investigator retains the primary responsibility
and dominant role for planning, directing, and executing the proposed
project; however, substantial NIH scientific and/or programmatic involvement
with the awardee is anticipated during the performance of the activities.
Under a cooperative agreement, NIH staff is expected to support and stimulate
the project by involvement in and otherwise working jointly with the award
recipient as a partner. This interaction is further described under the
section COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD. The U54
mechanism may support any part of a full range of research and development,
from the very basic to early clinical activities.
FUNDS AVAILABLE
For Fiscal Year 2005, the NIAID intends to commit approximately $21 million
to fund two (2) RCEs in response to this RFA. It is anticipated that awards
will be made in the range of $8-12 million total costs per year. An
applicant may request a project period of up to five years. Because the
nature and scope of the proposed research will vary from application to
application, the size and duration of each award may also vary. To ensure
that research aims can be met and biohazards can be contained, an applicant
may request up to $500,000 for significant alterations and renovations and/or
up to $300,000 for major related equipment. Although current NIAID plans
include support for this program, awards pursuant to this RFA are contingent
upon the availability of funds and the receipt of a sufficient number of
applications of high scientific merit.
ELIGIBLE INSTITUTIONS
A consortium of investigators, at more than one institution, who are working
together to pursue basic and applied research and development activities with
a common theme that focuses on countering the threat of NIAID Category A-C
agents, may apply. An application must contain several interactive research
projects that constitute an interdisciplinary approach to the development of
therapeutics, vaccines, or diagnostics for these agents. Applicant groups
must be able to fully implement all of the required elements of an RCE.
Applications that include participants from more than one region may be
submitted. Foreign organizations are not eligible to serve as grantees and
may not receive sub-contracts from domestic awards.
Applicant organizations that may respond to this RFA include:
o For-profit or non-profit organizations
o Public or private research institutions, such as universities, colleges,
hospitals, and laboratories
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to carry
out the required RCE activities is invited to form a consortium as described
above, and develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
An NIH intramural scientist (IMS) may not serve as the Principal Investigator
but may participate as a member researcher of the RCE. The participation of
an IMS is independent of and unrelated to the responsibilities of the NIAID
Program Staff as described below. An IMS who is one of the Center's member
scientists will have the same programmatic rights and responsibilities as
other investigators.
SPECIAL REQUIREMENTS
Consortium Plan
In order to promote discussion and early consensus among the applicants
regarding intellectual property (IP) and management matters that may arise
during RCE consortium projects, the applicants are required to submit a
consortium plan within six (6) months of the receipt of an award, and this
requirement will be a term of award. While the specific terms of such a plan
are left to the parties involved, NIAID recommends that the applicants
consider the following points in the plan:
o Measures to ensure the rapid utilization of inventions to benefit the
public health through, inter alia, diligence in seeking patent protection for
and licensing of new inventions when appropriate and the timely publication
of research results.
o Access by the RCE consortium participants to each others pre-existing IP
rights to background technology (inventions, know-how, materials,
information) required for performing RCE consortium projects -through, for
example, non-assertion clauses or cross-licenses.
o Timely reporting to the NIH of U.S. Government-funded inventions in
accordance with the Bayh-Dole Act, 35 U.S.C. 202, and the coordination of
patent filing, patent licensing and IP management for these inventions
(including addressing their use by other RCE consortium participants if
necessary for performing the RCE consortium projects).
o Ownership and management of inventions to include items such as assignment
of IP rights to employers, recognition of controlling U.S. law for U.S.
Government-funded inventions and, for joint inventions, agreements that
address licensing strategy and royalty sharing.
o Exclusive/non-exclusive licensing option for commercial RCE consortium
participants.
o Notice of rights retained by the U.S. Government in inventions arising from
federally funded RCE consortium projects.
o Publication reporting and confidentiality to promote the preservation of
patent filing rights.
o Other technology transfer activities among the various RCE consortium
participants, including but not limited to transfers of biological materials
and other tangibles.
o Disposition of IP rights and tangible materials at the
expiration/termination of the RCE consortium and also upon the early
departure of RCE consortium participants.
o Sharing of research reagents and research tools for research purposes among
RCE consortium participants and with other parties in accordance with the NIH
Principles and Guidelines on Biomedical Research Resources
(http://www.ott.nih.gov/policy/rt_guide_final.html).
o Coordination of IP/technology transfer matters between the technology
transfer/legal offices and the grants/contracts/sponsored research offices of
academic/non-profit RCE consortium participants.
o Overall RCE consortium management and, for major RCE consortium projects
that will utilize IP, tangible property and other resources of the RCE’s
commercial participants (e.g., proprietary materials, trade secrets and other
confidential information, personnel, budget, facilities/equipment, etc.), a
management scheme that encourages the participation of those commercial
participants.
o A mechanism for resolving disputes among the RCE consortium participants.
o Terms for the potential addition and departure of RCE consortium
participants.
o Legal liability of the RCE consortium participants.
Select Agents
All awardee institutions must confirm that they are in compliance with Select
Agent regulations (http://www.cdc.gov/od/sap) and NIH Guidelines for Research
Involving Recombinant DNA Molecules
(http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html) to receive
funding from NIAID. See also TERMS AND CONDITIONS OF AWARD.
Meetings
One determinant of success of the NIAID Biodefense Network will be the degree
of communication among the participants. As such, the NIAID Biodefense
Network will meet twice yearly or as needed in the event of a bioterrorism
emergency event. The purpose of these meetings is to: share scientific
information; assess scientific progress; identify new research and
development opportunities and potential avenues of collaborations such as
those with industry, private foundations, NIH intramural scientists, and
other federal government agencies; and establish priorities that will
accelerate the translation of preclinical findings into clinical
applications, reallocate resources and conduct other business of the RCE
Program.
RCE Principal Investigators must attend and participate as voting members in
the regular meetings and teleconferences to discuss progress and directions
of research and to ensure that overall Program goals are being met. The
support for attendance at NIAID Biodefense Network meetings can be provided
through the award as part of the administrative core travel budget.
Principal Investigators must coordinate and participate in regular, local
meetings of the RCE to discuss progress and directions of center activities
and to ensure that the necessary interdisciplinary interactions are taking
place. Principal Investigators and appropriate other RCE investigators must
attend an RCE Program Annual Scientific Meeting to be organized by the
Network and participate in Network teams to advance RCE Program business.
NIH Intramural Scientist Involvement
A collaborating NIH intramural scientist (IMS) may not receive salary,
equipment, supplies, or other remuneration from this award. The IMS must
obtain written approval of his/her Institute’s Scientific Director to
allocate resources to the project. The letter of approval must specify that
no more than $600,000 direct costs of intramural resources will be allocated
to the project and provide assurance that the conduct of the project will
comply with the DHHS regulations for research involving human subjects (if
applicable) and with the PHS policy for vertebrate animal research, as well
as other pertinent matters such as select agents.
COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD
The administrative and funding instrument used for this program is a
cooperative centers agreement (U54), an "assistance" mechanism (rather than
an "acquisition" mechanism) in which substantial NIH scientific and
programmatic involvement with the awardee is anticipated during the grant
award. Cooperative agreements are subject to the same administrative
requirements as grants. The following Terms and Conditions of Award are in
addition to, and not in lieu of, otherwise applicable OMB administrative
guidelines, HHS grant administration regulations in 45 CFR Part 74 and 92 and
administered under the NIH Grants Policy Statement.
1. Clinical Terms of Award
When clinical studies or trials are a component of the research proposed,
NIAID policy requires that studies be monitored commensurate with the degree
of potential risk to study subjects and the complexity of the study. An
Updated NIAID policy was published in the NIH Guide on July 8, 2002 and is
available at:
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-02-032.html.
The full policy, including terms and conditions of award, is available at:
http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf.
2. Awardee Rights and Responsibilities
Awardees will have primary responsibility for the project as a whole,
including research design and conduct, data collection, data quality control,
data analysis and interpretation and preparation of publications, as well as
collaborations with other awardees.
Awardees will retain primary custody of and have primary rights to the data
developed under these awards, subject to government rights of access
consistent with current HHS, PHS, and NIH policies. However, awardees must
be committed to making the therapeutics, vaccines, diagnostic products, other
research tools, and research materials they develop available to the
biodefense and emerging infectious disease research community through the
NIAID Biodefense and Emerging Infections Research Resources Repository
(http://www.beiresources.org).
Principal Investigators must coordinate and participate in regular, local
meetings of the RCE to discuss progress and directions of center activities
and to ensure that the necessary interdisciplinary interactions are taking
place. Principal Investigators and appropriate other RCE investigators must
attend an RCE Program Annual Scientific Meeting to be organized by the
Network and participate in Network teams to advance RCE Program business.
RCE Principal Investigators must attend and participate as voting members in
the regular meetings and teleconferences of the NIAID Biodefense Network to
discuss progress and directions of research and to ensure that overall
Program goals are being met.
An awardee is required to submit a consortium plan regarding intellectual
property (IP) and management matters that may arise during RCE consortium
projects within six (6) months of the receipt of an award, for NIAID
approval.
Awardees agree to participate in projects identified by the NIAID Biodefense
Network that include common research interests that address a specific
problem or threat.
Awardees will submit annual progress reports to the NIAID that describe
activities and accomplishments during the previous funding/reporting period.
Awardees must ensure that the core facilities of the RCE are utilized to the
fullest extent possible and that procedures remain in place to make core
facilities available to qualified users in the region from outside the RCE.
Awardees who conduct research involving Select Agents (see 42 CFR 73 for the
Select Agent list; and 7 CFR 331 and 9 CFR 121 for the relevant animal and
plant pathogens) must complete registration with CDC (or USDA, depending on
the agent) before using NIH funds. No funds can be used for research
involving Select Agents if the final registration certificate is denied.
Awardees must adhere to the Principles and Guidelines for Recipients of NIH
Research Grants and Contracts on Obtaining and Disseminating Biomedical
Research Resources (64 Federal Register 72090). The Principles and
Guidelines can be accessed electronically at: (http://ott.od.nih.gov).
An NIH intramural scientist (IMS) may participate as a member researcher of
the RCE. The participation of an IMS is independent of and unrelated to the
responsibilities of the NIAID Program Staff as described below. An IMS who
is one of the Center's member scientists will have the same programmatic
rights and responsibilities as other investigators.
3. NIAID Program Staff Responsibilities
The role of RCE Program Staff Scientist in the cooperative agreement is to
support and encourage the recipient's activities by substantial involvement
above and beyond normal program stewardship as facilitators in the process
without assuming responsibilities that remain with the PI. The RCE Program
Staff Scientist from the NIAID Division of Microbiology and Infectious
Diseases assigned to each RCE will work closely with the PI and other RCE
member scientists to facilitate collaborations with other NIAID-funded
research groups and to leverage the resources available to the Program.
Other NIAID staff will be responsible for normal program stewardship and
monitoring of award.
The NIAID Program Staff Scientist will monitor the progress of the RCE,
assisting in the coordination of research approaches among Centers, and
contributing to the fine-tuning of research projects or approaches as
warranted. The NIAID Program Staff Scientist will support and facilitate
this process but not direct it, and will also provide assistance with all
major transitional changes of an individual RCE's activities prior to
implementation to assure consistency with the overall goals of the RCE
Program and the NIAID biodefense mission. When necessary, issues may be
brought to the NIAID Biodefense Network for discussion.
The NIAID Program Staff Scientist will keep the RCEs informed about other
ongoing studies supported by NIAID to avoid duplication of effort and
encourage sharing/collaboration in the development of new clinically useful
reagents and methodologies for biodefense and emerging infectious diseases
research. The NIAID Program Staff Scientist will coordinate access for the
RCE to other NIAID resources as well as assist the research efforts of the
RCEs by facilitating access to fiscal and intellectual resources provided by
industry, private foundations, NIH intramural scientists and other federal
government agencies.
The NIAID Program Staff Scientist may assist, where warranted, in data
analyses and interpretation, and the dissemination of study findings to the
research community and health care recipients, including co-authorship of the
publication of results of studies conducted by the RCEs, subject to NIH
publication policies.
4. Collaborative Responsibilities
The NIAID Biodefense Network will provide overall scientific coordination of
the RCE Program. RCE Principal Investigators, National Biocontainment
Laboratory and Regional Biocontainment Laboratory Principal Investigators,
and the overall NIAID RCE Program Director will be voting members.
Additional NIAID Program Staff and scientists other than PIs may participate
as non-voting members.
The NIAID Biodefense Network may determine the need to redirect certain RCE
efforts when results and data suggest that the proposed research is no longer
feasible or progressing toward desired goals. Some RCEs will develop common
research interests; research focus groups may be formed to pursue coordinated
research activities identified by the NIAID Biodefense Network, and the
Network may be called upon to make recommendations regarding approaches to
specific threat agents and emerging infectious diseases that require new
attention as the need arises. The Network will also provide a forum for
coordinating RCE activities that require a liaison function with other
federal agencies such as the Food and Drug Administration, USDA, and CDC.
5. Arbitration
When agreement between an awardee and NIAID staff about
scientific/programmatic issues that may arise after the award cannot be
reached, an arbitration panel will be formed. The panel will consist of one
person selected by the awardee, one person selected by NIAID staff, and a
third person selected by the two. The decision of the arbitration panel, by
majority vote, will be binding. This special arbitration procedure in no way
affects the right of an awardee to appeal an adverse action in accordance
with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45
CFR Part 16.
These special Terms of Award are in addition to and not in lieu of otherwise
applicable OMB administrative guidelines, HHS Grant Administration
Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant
Administration policy statements.
WHERE TO SEND INQUIRIES
Written and telephone inquiries from potential applicants to answer questions
or clarify any issues about the RCE Program and this RFA are welcome.
Applicants are strongly encouraged to discuss their plans with NIAID Program
Staff to determine suitability. Inquiries may fall into three areas:
programmatic, peer review, and financial or grants management issues.
Direct inquiries regarding programmatic issues to:
Rona Hirschberg, Ph.D. (rh199i@nih.gov)
Alicia Dombroski, Ph.D. (ad211y@nih.gov)
Susan Garges, Ph.D. (sg9g@nih.gov)
Michael Hevey, Ph.D. (mh484c@nih.gov)
RCE Program
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infections Diseases
Room 5007, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone (301) 402-4197
Fax: (301) 480-1263
Direct inquiries regarding peer review issues to:
Katherine White
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room Number 3131, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: 301-435-1615
FAX: 301-402-2638
Email: kw174b@nih.gov
Direct inquiries regarding financial or grants management matters to:
Lesia Norwood
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room Number 2117, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: 301-402-7146
FAX: 301-493-0597
Email: ln5t@nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that includes
the following information:
o Descriptive title of the proposed research
o Name, address, telephone number and e-mail address of the Principal
Investigator
o Names of other key personnel
o Names of Institution(s) participating in the RCE application
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does not
enter into the review of subsequent applications, the information that it
contains allows NIAID staff to estimate the potential review workload and
plan the review.
The letter of intent must be received by August 9, 2004. The letter of
intent should be sent to:
Katherine White
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room Number 3131, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: 301-435-1615
FAX: 301-402-2638
Email: kw174b@nih.gov
SUBMITTING AN APPLICATION
Applicants for U54 grants must follow special application guidelines in the
NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT
AWARDS; this brochure is available via the WWW at:
http://www.niaid.nih.gov/ncn/grants/multibron.htm.
Applications must be prepared using the PHS 398 research grant application
instructions and forms (rev. 5/2001). Applications must have a DUN and
Bradstreet (D&B) Data Universal Numbering System (DUNS) number as the
Universal Identifier when applying for Federal grants or cooperative
agreements. The DUNS number can be obtained by calling (866) 705-5711 or
through the web site at http://www.dunandbradstreet.com/. The DUNS number
should be entered on line 11 of the face page of the PHS 398 form. The PHS
398 document is available at
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive
format. For further assistance contact GrantsInfo, Telephone (301) 710-0267,
Email: GrantsInfo@nih.gov.
SUPPLEMENTARY INSTRUCTIONS
The application should be assembled in this order:
PHS 398 Face page
PHS 398 Form Page 2 for the entire application
List of all participating institutions and key investigators/personnel at
each
Overall table of contents
Summary budget (chart) for the entire center
PHS 398 Form Page 5
Biographical sketch of PI
Research plan - Must have the following five sections - Note that face pages,
biographical sketches, budget pages, literature citations, letters of
support, checklists and other form pages are excluded from the page limits
below.
1. Background, Strategic Plan, and Management of the RCE May not exceed 50
pages; this component will be weighted 30% in the overall score.
a. Introduction, to include:
o Overall goals of the RCE
o Chronological review of planning and priority setting processes
o Letter(s) of commitment from participating institutions (these letters of
commitment do not count against the page limit)
b. Strategic Plan, to include:
o Strengths
o Opportunities
o Research Theme
o Action Plan
o Outcome Measures
o Emergency Response Plan
c. Administrative Core, to include:
o Face page
o PHS 398 Form page 2
o Biographical sketches
o Budget, using PHS 398 Form Pages 4 and 5, and budget justification
o Discussion of the Administrative Core
2. Research Program - Each application must include at least five single- or
multi-project Research Projects. Each single-project (RO1 type) Research
Project has a 25 page limit [sections A-D as defined in the PHS 398
instructions] and each multi-project (PO1 type) Research Project has a 35
page limit, with a maximum of 175 pages total for the Research Program,
regardless of the number or complexity of the Research Projects. The
inclusion of experimental procedures within the human subjects or vertebrate
animal sections of the application, or in the appendix to circumvent page
limits is not allowed. Components 2 (Research Program) and 3 (Scientific
Facilities Cores) will together be weighted 50% in the overall score.
For each single-project Research Project include:
o Face page
o PHS 398 Form Page 2
o Budget pages (PHS 398 Form Pages 4 and 5) and budget justification
o Biographical sketches
o Sections A-D
o Human subjects
o Vertebrate animals
o Literature cited
o Checklist
For each multi-project Research Project include:
o Introduction to the entire multi-project (text counts toward page limits,
literature cited does not)
o All budgets and budget justifications for the project (form pages 4 and 5
for each subproject, clearly labeled as to sub-project, and a summary table
for the overall project)
o For each subproject include
o Face page
o PHS 398 Form Page 2
o Biographical sketches
o Section A-D
o Human subjects
o Vertebrate animals
o Literature cited
o All checklists, clearly labeled as to subproject
3. Scientific Facilities Cores May not exceed 10 pages each [sections A-D
as defined in the PHS 398 instructions], with a maximum of 70 pages total.
Components 2 (Research Program) and 3 (Scientific Facilities Cores) will
together be weighted 50% in the overall score.
For each Scientific Core include:
o Face page
o PHS 398 Form Page 2
o Biographical sketches
o Budget, using PHS 398 Form Pages 4 and 5 and budget justification
o Description of the Core and its operations, and justification
o Human subjects
o Vertebrate animals
o Checklist
4. Developmental Research Plan - May not exceed 10 pages [sections A-D as
defined in the PHS 398 instructions]; this component will be weighted 10% in
the overall score.
Developmental Research Plan must include:
o Face page
o Biographical sketches
o Description of the plan for conducting the Developmental Research
activities
o Budget, using PHS 398 Form pages 4 and 5 (with amounts requested under
Other Expenses) and budget justification
5. Career Development and Training Program May not exceed 10 pages per
project [sections A-D as defined in the PHS 398 instructions], with a maximum
of 30 pages total for all Career Development Projects; this component will be
weighted 10% in the overall score.
For each project include:
o Face page
o PHS Form page 2
o Budget, using PHS 398 Form Pages 4 and 5, and budget justification
o Biographical sketches
o Description of project
o Human subjects
o Vertebrate animals
o Literature cited
o Checklist
Checklist for the entire application.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/01)
application form must be affixed to the bottom of the face page of the
application. Type the RFA number on the label. Failure to use this label
could result in delayed processing of the application such that it may not
reach the review committee in time for review. In addition, the RFA title
and number must be typed on line 2 of the face page of the application form
and the YES box must be marked. The RFA label is also available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of
the application, including the checklist, and three signed photocopies, in
one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040 - MSC 7710
Bethesda, MD 20892-7710
(20817 for Express Service)
At the time of submission, two additional copies and all five copies of
appendix material for the application must also be sent to:
Katherine White
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room Number 3131, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: 301-435-1615
FAX: 301-402-2638
Email: kw174b@nih.gov
Applications that are not received as a single package on or before the
September 9, 2004 or that do not conform to the instructions contained in PHS
398 (rev. 5/01) Application Kit (as modified in, and superseded by, the NIAID
BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS"),
will be judged non-responsive and will be returned to the applicant.
Investigators wishing to participate in a multi-project grant must be aware
of this policy before making a commitment to the Principal Investigator and
awarding institution.
It is highly recommended that the appropriate NIAID program contact be
consulted before submitting the letter of intent and during the early stages
of preparation of the application. (See program contact under INQUIRIES).
SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA:
Applicants for U54 cooperative agreements must follow special application
guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR
MULTI-PROJECT AWARDS; this brochure is available from NIAID listed under
INQUIRIES via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm.
This brochure presents specific instructions for sections of the PHS 398
(rev. 5/01) application form that should be completed differently than usual.
For all other items in the application, follow the usual instructions in the
PHS 398.
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the applicant
without review.
The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. Only
new applications will be accepted for this RFA. Applications must meet all
eligibility requirements as described above and must address all programmatic
requirements (see SPECIAL REQUIREMENTS above) in the RFA.
APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL INSTITUTE OF
ALLERGY AND INFECTIOUS DISEASES WILL NO LONGER BE ACCEPTED. This policy does
not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.)
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html) This
change in practice is effective immediately. This policy is similar to and
consistent with the policy for applications addressed to Centers for
Scientific Review as published in the NIH Guide Notice
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and funding
assignment within 8 weeks.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the NIAID. Incomplete or non-responsive applications will
be returned to the applicant without further consideration or review.
Applications that are complete and responsive to the RFA will be evaluated
for scientific and technical merit by an appropriate peer review group
convened by the NIAID, in accordance with the review criteria stated below.
Depending on the total number and research topics of applications received in
response to this RFA, applications may be separated into subgroups for review
by different peer review committees. As part of the initial merit review,
all applications will:
o Undergo a selection process in which only those applications deemed to have
the highest scientific merit will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Institute Allergy and
Infectious Diseases Advisory Board
The NIH reserves the right to conduct site visits or reverse site visits when
deemed essential.
REVIEW CRITERIA
The general review criteria for U54 multi-project cooperative agreement
applications are presented in the NIAID brochure entitled "INSTRUCTIONS FOR
APPLICATIONS FOR MULTI-PROJECT AWARDS at
http://www.niaid.nih.gov/ncn/grants/multibron.htm.
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following
items will be considered in the determination of scientific merit and the
priority score:
Overall Evaluation and Scoring
The overall application score will be based on review and merit of the
individual components as well as the merit of the application taken as a
whole. A single numerical priority score will be assigned to the whole
application after consideration of all of the elements listed below.
The Background, Strategic Plan and Management of the RCE, the individual
Research Projects and the Research Program as a whole; the Career Development
plan as a whole; and the Developmental Research Projects plan as a whole will
be assigned numerical priority scores. The Scientific Facilities Cores will
be scored using qualitative descriptors. Each of the scores will contribute
to the final overall score with the following weights given to the various
components: Research Program and Scientific Facilities Cores combined, 50%;
Introduction, Strategic Plan and Management of the RCE, 30%; Career
Development program, 10%; and Developmental Research plan, 10%.
The overall score for the application will be based on the scientific merit
of the individual components as well as the overall synergy and integration
of the components, the effectiveness and adequacy of plans for sharing
resources, the overall program organization and capability of the associated
personnel, and the extent to which having a RCE would contribute to the
global NIAID biodefense mission and achieve wide geographical distribution of
Centers.
Criteria and Attributes to Consider for Evaluation of Application Components:
Background, Strategic Plan, and Management of the RCE
o Feasibility, innovation and scientific/technical merit of the proposed
goals of the RCE as well as the plans to achieve those goals.
o Potential for the proposed RCE to develop critical, new knowledge about
biodefense and emerging infectious diseases, and to enhance regional research
and development capabilities.
o Feasibility of the proposed research to span basic as well as
translational/clinical issues and potential for the proposed research goals
to lead to vaccines, diagnostics and therapeutics for NIAID Category A-C
agents.
o Strength, merit and feasibility of plans to promote synergistic
interactions among the participants of the proposed Center.
o Strength, merit and feasibility of plans for Center interactions with
federal, state and local agencies or with industrial partners; and for rapid
and effective communication among the proposed participants and with the
broader constituency of the Center.
o Scientific/technical merit and feasibility of the proposed milestones, and
appropriateness and feasibility of the proposed metrics to quantify and
ascertain productivity.
o Appropriateness and feasibility of plans to incorporate research projects
and/or cores in response to emerging opportunities or to eliminate
unproductive projects and/or cores.
o Merit and appropriateness of the documented institutional support for the
goals of the Center, including the commitment of additional resources.
o Strength, merit and feasibility of documented plans to leverage additional
scientific and technical resources to increase the impact of NIAID funds.
o Merit and feasibility of the documented capability and interest of the
proposed institution(s) to serve as a regional biodefense first responder.
o Appropriateness and feasibility of plans to rapidly develop the Center.
o Adequacy of the training, experience, level of commitment, availability and
qualifications of the Principal Investigator and key personnel of the
leadership team to successfully lead and manage the proposed Center.
o Appropriateness and clarity of the organizational structure and other plans
for managing the Center's activities for prioritization of competing needs.
o Appropriateness and clarity of the administrative structure and lines of
authority as well as plans for alternate lines of authority in the Principal
Investigator's absence.
o Appropriateness of plans to make the Center and its resources available to
investigators and institutions throughout the region.
o Appropriateness of the management plan for fiscal accountability and
communications within the Center.
Research Program
The following review criteria for research projects will be applied to each
project in the context of how the project supports the strategic plan and
advances the overall goals of the Center.
o Significance - Relevance of the research proposed for advancing the
biodefense mission of the NIAID, contributing to the RCE strategic plan, and
inclusion of an appropriate representation of NIAID Category A-C agents.
o Approach - Appropriateness of the conceptual framework, design, methods,
and analyses for the aims of the project and the RCE program. An effective
strategy for selecting approaches and technologies within the RCE to address
the research questions should be evident. Where appropriate, investigators
should include approaches that will translate into safe, feasible and useful
therapeutics, vaccines, and diagnostics.
o Innovation - Novelty of concepts, approaches and methods. Project leaders
should seek to advance, extend or challenge existing paradigms, or develop
new methodologies or technologies relevant to biodefense. However, some
significant and important studies may not be inherently innovative, and this
should be considered when evaluating this criterion.
o Investigator - Appropriateness of the training, qualifications, experience,
and accomplishments of the project leader which relate to the ability to
accomplish the proposed project. The project leader is expected to allocate
sufficient effort to RCE activities. The application should provide
documentation that the project leaders have the aptitude and volition to
function as part of an integrated team.
o Environment - Adequacy of the accessibility of personnel at the
institution(s) who are experienced with NIAID Category A-C Agents consistent
with the proposed research. Adequate, appropriate facilities must be
available. For projects that include translational and clinical studies,
there should be adequate support and expertise available for the successful
pursuit of the proposed work. Projects should include a plan to take
advantage of Center resources and for inclusion of the project into Center
activities.
o Clinical Studies - Because one of the goals of the RCE program is to
discover and develop products for human use, the necessity for research
involving human subjects or clinical materials is obvious. However, careful
consideration should be given to the appropriateness and scope of projects
which involve clinical studies. While small proof-of-concept Phase I or
Phase I/II clinical trials are appropriate, large Phase II or III clinical
studies are beyond the scope of this research program.
Multi-project Research Projects will be further evaluated for cohesiveness,
the suitability of plans for collaboration and exchange of ideas among
participants, and for evidence that program components will bring synergy and
added value to overall Center activities.
Scientific Facilities Cores
o Appropriateness of the proposed core facilities in the context of the
overall strategic plan and the proposed research and training activities.
o Feasibility and clarity of plans for prioritizing the use of facilities,
for allocating availability to the proposed research projects, and for
ensuring that the core facilities are used to the fullest extent including
access by non-RCE investigators and institutions.
o Qualifications, experience and commitment of key personnel for running the
core facilities.
o Documented merit of the core proposed in the context of existing facilities
in the Center and region.
o Adequacy and feasibility of plans to ensure that during a time of National
biodefense emergency the cores will re-align their activities to assist in
the local response through research activities.
o Appropriateness of the schedule of user fees set to ensure broad
accessibility and utilization by regional partners, particularly those with
limited resources.
o Clarity of the need for BSL3/4 facilities.
o Adequacy and feasibility of plans to establish linkages to existing BSL3/4
facilities.
o Collective experience of Center participants in the operation of
biocontainment facilities and ability to provide training for use of any
proposed biocontainment facilities.
o Adequacy and feasibility of the phase in plans to provide a mechanism for
research to proceed until new BSL3/4 capacity is on-line.
Developmental Research Plan
o Strength, feasibility and appropriateness of the proposed plan and criteria
to select new developmental projects and monitor their long term success,
including adequacy of the strategy for selecting projects that leverage
resources and complement the Center's strengths.
o Inclusiveness and feasibility of the developmental project plan for
bringing new investigators into the biodefense research area, and recruitment
strategies to ensure a broad pool of applicants and scientific topics for the
development projects.
o Adequacy of the proposed procedures and criteria for the phase-in and
phase-out of developmental projects and for the advancement of promising
developmental projects to full Research Project status.
Career Development Program
o Quality and appropriateness of the technical and scientific expertise,
mentoring experience, and availability of the faculty and staff to conduct
the proposed training.
o Strength of the documented available training infrastructure such as
laboratories, clinics, etc.
o Merit, feasibility and level of creativity of the proposed approaches to
increase the human resources available for biodefense including recruitment
of sufficient qualified students and trainees, and adequacy of plans for the
inclusion of women and minorities.
o Relevance of the proposed training to, and integration with, the goals of
the strategic plan.
o Appropriateness of the proposed training in relation to the current
education framework of the involved institution(s).
o Potential contribution of the specific training proposed to the overall RCE
mission.
o Suitability of plans for evaluation of the training and documenting
success.
ADDITIONAL REVIEW CRITERIA: The Research Program, the Developmental Research
plan, the Career Development Program, and the application as a whole will be
evaluated with respect to the following:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human
subjects and protections from research risk relating to their participation
in the proposed research will be assessed. (See criteria included in the
section on Federal Citations, below)
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of
plans to include subjects from both genders, all racial and ethnic groups
(and subgroups), and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be
evaluated. (See Inclusion Criteria in the sections on Federal Citations,
below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to
be used in the project, the five items described under Section f of the PHS
398 research grant application instructions (rev. 5/2001) will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct
costs in any year of the proposed research are expected to include a data
sharing plan in their application. The reasonableness of the data sharing
plan or the rationale for not sharing research data will be assessed by the
reviewers. However, reviewers will not factor the proposed data-sharing plan
into the determination of scientific merit or priority score. (See
instructions and URL to policy in the Federal Citations, below.)
BUDGET: The reasonableness of the proposed budget and the requested period of
support in relation to the proposed research.
RECEIPT AND REVIEW SCHEDULE
Letter of Intent Receipt Date: August 9, 2004
Application Receipt Date: September 9, 2004
Peer Review: December, 2004
Earliest Anticipated Award Date: April, 2005
AWARD CRITERIA
If multiple applications from a single region are reviewed and scored, the
NIAID reserves the right to negotiate the merging of the two into a single
RCE. This will be done based upon the peer review-identified strengths and
weaknesses of each application, and programmatic need. NIAID may also
negotiate prior to award to modify the scope of the proposed research and
other activities to meet overall program needs.
In addition to Scientific Merit, other criteria that will be used to make
award decisions include:
o Availability of funds
o Programmatic priorities
o Coverage of desired research scope
o Regional distribution of meritorious applications
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated with
reference to the risks to the subjects, the adequacy of protection against
these risks, the potential benefits of the research to the subjects and
others, and the importance of the knowledge gained or to be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy,
effectiveness and comparative trials (phase III). The establishment of data
and safety monitoring boards (DSMBs) is required for multi-site clinical
trials involving interventions that entail potential risk to the
participants. (NIH Policy for Data Safety and Monitoring, NIH Guide for
Grants and Contracts, June 12, 1998:
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
investigators submitting an NIH application seeking $500,000 or more in
direct costs in any single year are expected to include a plan for data
sharing or state why this is not possible.
http://grants.nih.gov/grants/policy/data_sharing Investigators should seek
guidance from their institutions, on issues related to institutional
policies, local IRB rules, as well as local, state and Federal laws and
regulations, including the Privacy Rule. Reviewers will consider the data
sharing plan but will not factor the plan into the determination of the
scientific merit or the priority score.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of
the NIH that women and members of minority groups and their sub-populations
must be included in all NIH-supported clinical research projects unless a
clear and compelling justification is provided indicating that inclusion is
inappropriate with respect to the health of the subjects or the purpose of
the research. This policy results from the NIH Revitalization Act of 1993
(Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the AMENDMENT "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical
Research - Amended, October, 2001," published in the NIH Guide for Grants and
Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
The amended policy incorporates: the use of an NIH definition of clinical
research; updated racial and ethnic categories in compliance with the new OMB
standards; clarification of language governing NIH-defined Phase III clinical
trials consistent with the new PHS Form 398; and updated roles and
responsibilities of NIH staff and the extramural community. The policy
continues to require for all NIH-defined Phase III clinical trials that: a)
all applications or proposals and/or protocols must provide a description of
plans to conduct analyses, as appropriate, to address differences by
sex/gender and/or racial/ethnic groups, including subgroups if applicable;
and b) investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS:
The NIH maintains a policy that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported
by the NIH, unless there are scientific and ethical reasons not to include
them. This policy applies to all initial (Type 1) applications submitted for
receipt dates after October 1, 1998.
All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines" on the inclusion of children as participants in
research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject participants for
all investigators submitting NIH proposals for research involving human
subjects. This policy announcement is in the NIH Guide for Grants and
Contracts Announcement, dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research
on hESCs can be found at http://stemcells.nih.gov/index.asp and at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only
research using hESC lines that are registered in the NIH Human Embryonic Stem
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).
It is the responsibility of the applicant to provide, in the project
description and elsewhere in the application as appropriate, the official NIH
identifier(s)for the hESC line(s)to be used in the proposed research.
Applications that do not provide this information will be returned without
review.
PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The
Office of Management and Budget (OMB) Circular A-110 has been revised to
provide public access to research data through the Freedom of Information Act
(FOIA) under some circumstances. Data that are (1) first produced in a
project that is supported in whole or in part with Federal funds and (2)
cited publicly and officially by a Federal agency in support of an action
that has the force and effect of law (i.e., a regulation) may be accessed
through FOIA. It is important for applicants to understand the basic scope
of this amendment. NIH has provided guidance at
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this RFA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application should
include a description of the archiving plan in the study design and include
information about this in the budget justification section of the
application. In addition, applicants should think about how to structure
informed consent statements and other human subjects procedures given the
potential for wider use of data collected under this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The
Department of Health and Human Services (DHHS) issued final modification to
the Standards for Privacy of Individually Identifiable Health Information ,
the Privacy Rule, on August 14, 2002. The Privacy Rule is a federal
regulation under the Health Insurance Portability and Accountability Act
(HIPAA) of 1996 that governs the protection of individually identifiable
health information, and is administered and enforced by the DHHS Office for
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified
under the Rule as covered entities ) must do so by April 14, 2003 (with the
exception of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule reside
with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including
a complete Regulation Text and a set of decision tools on Am I a covered
entity? Information on the impact of the HIPAA Privacy Rule on NIH
processes involving the review, funding, and progress monitoring of grants,
cooperative agreements, and research contracts can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals
for NIH funding must be self-contained within specified page limitations.
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs)
should not be used to provide information necessary to the review because
reviewers are under no obligation to view the Internet sites. Furthermore,
we caution reviewers that their anonymity may be compromised when they
directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of "Healthy
People 2010," a PHS-led national activity for setting priority areas. This
RFA is related to one or more of the priority areas. Potential applicants may
obtain a copy of "Healthy People 2010" at
http://www.health.gov/healthypeople.
AUTHORITY AND REGULATIONS
This program is described in the Catalogue of Federal Domestic Assistance at
http://www.cfda.gov/ in the following citations: No. 93.855, Immunology,
Allergy, and Transplantation Research and No. 93.856, Microbiology and
Infectious Diseases Research. Awards are made under authorization of Sections
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284)
and administered under NIH grants policies and Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.
The NIH Grants Policy Statement is available at
http://grants.nih.gov/grants/policy/policy.htm. This document includes
general information about the grant application and review process;
information on the terms and conditions that apply to NIH Grants and
cooperative agreements; and a listing of pertinent offices and officials at
the NIH. All awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants Policy
Statement.
The PHS strongly encourages all grant recipients to provide a smoke-free
workplace and discourage the use of all tobacco products. In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities (or in some cases, any portion of a facility) in which
regular or routine education, library, day care, health care, or early
childhood development services are provided to children. This is consistent
with the PHS mission to protect and advance the physical and mental health of
the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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