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) 435-0714, 
Email: GrantsInfo@nih.gov. 

SUPPLEMENTARY INSTRUCTIONS

The application should be assembled in this order: 

PHS 398 Face page
PHS 398 Form Page 2 for the entire application
List of all participating institutions and key investigators/personnel at 
each
Overall table of contents
Summary budget (chart) for the entire center 
PHS 398 Form Page 5
Biographical sketch of PI
Research plan - Must have the following five sections - Note that face pages, 
biographical sketches, budget pages, literature citations, letters of 
support, checklists and other form pages are excluded from the page limits 
below.

1. Background, Strategic Plan, and Management of the RCE – May not exceed 50 
pages; this component will be weighted 30% in the overall score.
      
a. Introduction, to include:
o Overall goals of the RCE
o Chronological review of planning and priority setting processes
o Letter(s) of commitment from participating institutions (these letters of 
commitment do not count against the page limit)

b. Strategic Plan, to include:
o Strengths
o Opportunities
o Research Theme
o Action Plan
o Outcome Measures
o Emergency Response Plan

c. Administrative Core, to include:
o Face page
o PHS 398 Form page 2
o Biographical sketches
o Budget, using PHS 398 Form Pages 4 and 5, and budget justification
o Discussion of the Administrative Core

2.  Research Program - Each application must include at least five single- or 
multi-project Research Projects.  Each single-project (RO1 type) Research 
Project has a 25 page limit [sections A-D as defined in the PHS 398 
instructions] and each multi-project (PO1 type) Research Project has a 35 
page limit, with a maximum of 175 pages total for the Research Program, 
regardless of the number or complexity of the Research Projects.  The 
inclusion of experimental procedures within the human subjects or vertebrate 
animal sections of the application, or in the appendix to circumvent page 
limits is not allowed.  Components 2 (Research Program) and 3 (Scientific 
Facilities Cores) will together be weighted 50% in the overall score.

For each single-project Research Project include:
o Face page
o PHS 398 Form Page 2
o Budget pages (PHS 398 Form Pages 4 and 5) and budget justification
o Biographical sketches 
o Sections A-D
o Human subjects
o Vertebrate animals 
o Literature cited
o Checklist

For each multi-project Research Project include:
o Introduction to the entire multi-project (text counts toward page limits, 
literature cited does not)
o All budgets and budget justifications for the project (form pages 4 and 5 
for each subproject, clearly labeled as to sub-project, and a summary table 
for the overall project) 
o For each subproject include
    o Face page 
    o PHS 398 Form Page 2
    o Biographical sketches
    o Section A-D 
    o Human subjects
    o Vertebrate animals
    o Literature cited
    o All checklists, clearly labeled as to subproject

3. Scientific Facilities Cores – May not exceed 10 pages each [sections A-D 
as defined in the PHS 398 instructions], with a maximum of 70 pages total.  
Components 2 (Research Program) and 3 (Scientific Facilities Cores) will 
together be weighted 50% in the overall score.

For each Scientific Core include:
o Face page
o PHS 398 Form Page 2
o Biographical sketches
o Budget, using PHS 398 Form Pages 4 and 5 and budget justification
o Description of the Core and its operations, and justification
o Human subjects
o Vertebrate animals
o Checklist

4. Developmental Research Plan - May not exceed 10 pages [sections A-D as 
defined in the PHS 398 instructions]; this component will be weighted 10% in 
the overall score. 

Developmental Research Plan must include:
o Face page
o Biographical sketches
o Description of the plan for conducting the Developmental Research 
activities
o Budget, using PHS 398 Form pages 4 and 5 (with amounts requested under 
Other Expenses) and budget justification

5. Career Development and Training Program – May not exceed 10 pages per 
project [sections A-D as defined in the PHS 398 instructions], with a maximum 
of 30 pages total for all Career Development Projects; this component will be 
weighted 10% in the overall score.

For each project include:

o Face page
o PHS Form page 2
o Budget, using PHS 398 Form Pages 4 and 5, and budget justification
o Biographical sketches
o Description of project
o Human subjects
o Vertebrate animals
o Literature cited
o Checklist

Checklist for the entire application.

USING THE RFA LABEL:  The RFA label available in the PHS 398 (rev. 5/01) 
application form must be affixed to the bottom of the face page of the 
application.  Type the RFA number on the label.  Failure to use this label 
could result in delayed processing of the application such that it may not 
reach the review committee in time for review.  In addition, the RFA title 
and number must be typed on line 2 of the face page of the application form 
and the YES box must be marked.   The RFA label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf. 

SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the checklist, and three signed photocopies, in 
one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive
Room 1040 - MSC 7710
Bethesda, MD  20892-7710
(20817 for Express Service)
 
At the time of submission, two additional copies and all five copies of 
appendix material for the application must also be sent to:

Katherine White 
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases 
Room Number 3131, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616 
Telephone:  301-435-1615
FAX:  301-402-2638 
Email:  kw174b@nih.gov

Applications that are not received as a single package on or before the 
September 9, 2004 or that do not conform to the instructions contained in PHS 
398 (rev. 5/01) Application Kit (as modified in, and superseded by, the NIAID 
BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS"), 
will be judged non-responsive and will be returned to the applicant. 

Investigators wishing to participate in a multi-project grant must be aware 
of this policy before making a commitment to the Principal Investigator and 
awarding institution.

It is highly recommended that the appropriate NIAID program contact be 
consulted before submitting the letter of intent and during the early stages 
of preparation of the application.  (See program contact under INQUIRIES).

SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS RFA:

Applicants for U54 cooperative agreements must follow special application 
guidelines in the NIAID Brochure entitled INSTRUCTIONS FOR APPLICATIONS FOR 
MULTI-PROJECT AWARDS; this brochure is available from NIAID listed under 
INQUIRIES via the WWW at: http://www.niaid.nih.gov/ncn/grants/multibron.htm.

This brochure presents specific instructions for sections of the PHS 398 
(rev. 5/01) application form that should be completed differently than usual.  
For all other items in the application, follow the usual instructions in the 
PHS 398.

APPLICATION PROCESSING:  Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the applicant 
without review.   

The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application. Only 
new applications will be accepted for this RFA.  Applications must meet all 
eligibility requirements as described above and must address all programmatic 
requirements (see SPECIAL REQUIREMENTS above) in the RFA. 

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL INSTITUTE OF 
ALLERGY AND INFECTIOUS DISEASES WILL NO LONGER BE ACCEPTED.  This policy does 
not apply to courier deliveries (i.e. FEDEX, UPS, DHL, etc.) 
(http://grants.nih.gov/grants/guide/notice-files/NOT-CA-02-002.html)  This 
change in practice is effective immediately.  This policy is similar to and 
consistent with the policy for applications addressed to Centers for 
Scientific Review as published in the NIH Guide Notice 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIAID.  Incomplete or non-responsive applications will 
be returned to the applicant without further consideration or review.

Applications that are complete and responsive to the RFA will be evaluated 
for scientific and technical merit by an appropriate peer review group 
convened by the NIAID, in accordance with the review criteria stated below.  
Depending on the total number and research topics of applications received in 
response to this RFA, applications may be separated into subgroups for review 
by different peer review committees.  As part of the initial merit review, 
all applications will:

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit will be discussed and assigned a priority score
o Receive a written critique 
o Receive a second level review by the National Institute Allergy and 
Infectious Diseases Advisory Board

The NIH reserves the right to conduct site visits or reverse site visits when 
deemed essential.  

REVIEW CRITERIA

The general review criteria for U54 multi-project cooperative agreement 
applications are presented in the NIAID brochure entitled "INSTRUCTIONS FOR 
APPLICATIONS FOR MULTI-PROJECT AWARDS” at 
http://www.niaid.nih.gov/ncn/grants/multibron.htm.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

Overall Evaluation and Scoring

The overall application score will be based on review and merit of the 
individual components as well as the merit of the application taken as a 
whole.  A single numerical priority score will be assigned to the whole 
application after consideration of all of the elements listed below.  

The Background, Strategic Plan and Management of the RCE, the individual 
Research Projects and the Research Program as a whole; the Career Development 
plan as a whole; and the Developmental Research Projects plan as a whole will 
be assigned numerical priority scores.  The Scientific Facilities Cores will 
be scored using qualitative descriptors.  Each of the scores will contribute 
to the final overall score with the following weights given to the various 
components:  Research Program and Scientific Facilities Cores combined, 50%; 
Introduction, Strategic Plan and Management of the RCE, 30%; Career 
Development program, 10%; and Developmental Research plan, 10%. 

The overall score for the application will be based on the scientific merit 
of the individual components as well as the overall synergy and integration 
of the components, the effectiveness and adequacy of plans for sharing 
resources, the overall program organization and capability of the associated 
personnel, and the extent to which having a RCE would contribute to the 
global NIAID biodefense mission and achieve wide geographical distribution of 
Centers.

Criteria and Attributes to Consider for Evaluation of Application Components:

Background, Strategic Plan, and Management of the RCE

o Feasibility, innovation and scientific/technical merit of the proposed 
goals of the RCE as well as the plans to achieve those goals. 
o Potential for the proposed RCE to develop critical, new knowledge about 
biodefense and emerging infectious diseases, and to enhance regional research 
and development capabilities.
o Feasibility of the proposed research to span basic as well as 
translational/clinical issues and potential for the proposed research goals 
to lead to vaccines, diagnostics and therapeutics for NIAID Category A-C 
agents.
o Strength, merit and feasibility of plans to promote synergistic 
interactions among the participants of the proposed Center.
o Strength, merit and feasibility of plans for Center interactions with 
federal, state and local agencies or with industrial partners; and for rapid 
and effective communication among the proposed participants and with the 
broader constituency of the Center.
o Scientific/technical merit and feasibility of the proposed milestones, and 
appropriateness and feasibility of the proposed metrics to quantify and 
ascertain productivity.
o Appropriateness and feasibility of plans to incorporate research projects 
and/or cores in response to emerging opportunities or to eliminate 
unproductive projects and/or cores.
o Merit and appropriateness of the documented institutional support for the 
goals of the Center, including the commitment of additional resources.
o Strength, merit and feasibility of documented plans to leverage additional 
scientific and technical resources to increase the impact of NIAID funds.
o Merit and feasibility of the documented capability and interest of the 
proposed institution(s) to serve as a regional biodefense first responder.
o Appropriateness and feasibility of plans to rapidly develop the Center.
o Adequacy of the training, experience, level of commitment, availability and 
qualifications of the Principal Investigator and key personnel of the 
leadership team to successfully lead and manage the proposed Center. 
o Appropriateness and clarity of the organizational structure and other plans 
for managing the Center's activities for prioritization of competing needs. 
o Appropriateness and clarity of the administrative structure and lines of 
authority as well as plans for alternate lines of authority in the Principal 
Investigator's absence.
o Appropriateness of plans to make the Center and its resources available to 
investigators and institutions throughout the region.
o Appropriateness of the management plan for fiscal accountability and 
communications within the Center.

Research Program

The following review criteria for research projects will be applied to each 
project in the context of how the project supports the strategic plan and 
advances the overall goals of the Center.
o Significance - Relevance of the research proposed for advancing the 
biodefense mission of the NIAID, contributing to the RCE strategic plan, and 
inclusion of an appropriate representation of NIAID Category A-C agents.
o Approach - Appropriateness of the conceptual framework, design, methods, 
and analyses for the aims of the project and the RCE program.  An effective 
strategy for selecting approaches and technologies within the RCE to address 
the research questions should be evident.  Where appropriate, investigators 
should include approaches that will translate into safe, feasible and useful 
therapeutics, vaccines, and diagnostics.
o Innovation - Novelty of concepts, approaches and methods. Project leaders 
should seek to advance, extend or challenge existing paradigms, or develop 
new methodologies or technologies relevant to biodefense.  However, some 
significant and important studies may not be inherently innovative, and this 
should be considered when evaluating this criterion.
o Investigator - Appropriateness of the training, qualifications, experience, 
and accomplishments of the project leader which relate to the ability to 
accomplish the proposed project.  The project leader is expected to allocate 
sufficient effort to RCE activities.  The application should provide 
documentation that the project leaders have the aptitude and volition to 
function as part of an integrated team.
o Environment - Adequacy of the accessibility of personnel at the 
institution(s) who are experienced with NIAID Category A-C Agents consistent 
with the proposed research. Adequate, appropriate facilities must be 
available.  For projects that include translational and clinical studies, 
there should be adequate support and expertise available for the successful 
pursuit of the proposed work.  Projects should include a plan to take 
advantage of Center resources and for inclusion of the project into Center 
activities.
o Clinical Studies - Because one of the goals of the RCE program is to 
discover and develop products for human use, the necessity for research 
involving human subjects or clinical materials is obvious.  However, careful 
consideration should be given to the appropriateness and scope of projects 
which involve clinical studies.  While small proof-of-concept Phase I or 
Phase I/II clinical trials are appropriate, large Phase II or III clinical 
studies are beyond the scope of this research program.  

Multi-project Research Projects will be further evaluated for cohesiveness, 
the suitability of plans for collaboration and exchange of ideas among 
participants, and for evidence that program components will bring synergy and 
added value to overall Center activities.

Scientific Facilities Cores
 
o Appropriateness of the proposed core facilities in the context of the 
overall strategic plan and the proposed research and training activities.
o Feasibility and clarity of plans for prioritizing the use of facilities, 
for allocating availability to the proposed research projects, and for 
ensuring that the core facilities are used to the fullest extent including 
access by non-RCE investigators and institutions.
o Qualifications, experience and commitment of key personnel for running the 
core facilities.
o Documented merit of the core proposed in the context of existing facilities 
in the Center and region.
o Adequacy and feasibility of plans to ensure that during a time of National 
biodefense emergency the cores will re-align their activities to assist in 
the local response through research activities.
o Appropriateness of the schedule of user fees set to ensure broad 
accessibility and utilization by regional partners, particularly those with 
limited resources.
o Clarity of the need for BSL3/4 facilities.
o Adequacy and feasibility of plans to establish linkages to existing BSL3/4 
facilities.
o Collective experience of Center participants in the operation of 
biocontainment facilities and ability to provide training for use of any 
proposed biocontainment facilities.
o Adequacy and feasibility of the phase in plans to provide a mechanism for 
research to proceed until new BSL3/4 capacity is on-line.

Developmental Research Plan

o Strength, feasibility and appropriateness of the proposed plan and criteria 
to select new developmental projects and monitor their long term success, 
including adequacy of the strategy for selecting projects that leverage 
resources and complement the Center's strengths.
o Inclusiveness and feasibility of the developmental project plan for 
bringing new investigators into the biodefense research area, and recruitment 
strategies to ensure a broad pool of applicants and scientific topics for the 
development projects.
o Adequacy of the proposed procedures and criteria for the phase-in and 
phase-out of developmental projects and for the advancement of promising 
developmental projects to full Research Project status.   

Career Development Program

o Quality and appropriateness of the technical and scientific expertise, 
mentoring experience, and availability of the faculty and staff to conduct 
the proposed training.
o Strength of the documented available training infrastructure such as 
laboratories, clinics, etc. 
o Merit, feasibility and level of creativity of the proposed approaches to 
increase the human resources available for biodefense including recruitment 
of sufficient qualified students and trainees, and adequacy of plans for the 
inclusion of women and minorities.
o Relevance of the proposed training to, and integration with, the goals of 
the strategic plan.
o Appropriateness of the proposed training in relation to the current 
education framework of the involved institution(s).
o Potential contribution of the specific training proposed to the overall RCE 
mission.
o Suitability of plans for evaluation of the training and documenting 
success.

ADDITIONAL REVIEW CRITERIA: The Research Program, the Developmental Research 
plan, the Career Development Program, and the application as a whole will be 
evaluated with respect to the following: 

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below)

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy of 
plans to include subjects from both genders, all racial and ethnic groups 
(and subgroups), and children as appropriate for the scientific goals of the 
research. Plans for the recruitment and retention of subjects will also be 
evaluated. (See Inclusion Criteria in the sections on Federal Citations, 
below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.

ADDITIONAL REVIEW CONSIDERATIONS

SHARING RESEARCH DATA: Applicants requesting more than $500,000 in direct 
costs in any year of the proposed research are expected to include a data 
sharing plan in their application. The reasonableness of the data sharing 
plan or the rationale for not sharing research data will be assessed by the 
reviewers. However, reviewers will not factor the proposed data-sharing plan 
into the determination of scientific merit or priority score. (See 
instructions and URL to policy in the Federal Citations, below.)

BUDGET: The reasonableness of the proposed budget and the requested period of 
support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:      August 9, 2004
Application Receipt Date:           September 9, 2004
Peer Review:                        December, 2004
Earliest Anticipated Award Date:    April, 2005

AWARD CRITERIA

If multiple applications from a single region are reviewed and scored, the 
NIAID reserves the right to negotiate the merging of the two into a single 
RCE.  This will be done based upon the peer review-identified strengths and 
weaknesses of each application, and programmatic need.   NIAID may also 
negotiate prior to award to modify the scope of the proposed research and 
other activities to meet overall program needs.

In addition to Scientific Merit, other criteria that will be used to make 
award decisions include:

o Availability of funds
o Programmatic priorities
o Coverage of desired research scope
o Regional distribution of meritorious applications

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained.  
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants. (NIH Policy for Data Safety and Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA:  Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking $500,000 or more in 
direct costs in any single year are expected to include a plan for data 
sharing or state why this is not possible.  
http://grants.nih.gov/grants/policy/data_sharing Investigators should seek 
guidance from their institutions, on issues related to institutional 
policies, local IRB rules, as well as local, state and Federal laws and 
regulations, including the Privacy Rule. Reviewers will consider the data 
sharing plan but will not factor the plan into the determination of the 
scientific merit or the priority score.

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm
The amended policy incorporates: the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. This policy applies to all initial (Type 1) applications submitted for 
receipt dates after October 1, 1998.

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  This policy announcement is in the NIH Guide for Grants and 
Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research 
on hESCs can be found at http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see http://escr.nih.gov).   
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, the official NIH 
identifier(s)for the hESC line(s)to be used in the proposed research.  
Applications that do not provide this information will be returned without 
review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The 
Office of Management and Budget (OMB) Circular A-110 has been revised to 
provide public access to research data through the Freedom of Information Act 
(FOIA) under some circumstances.  Data that are (1) first produced in a 
project that is supported in whole or in part with Federal funds and (2) 
cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law (i.e., a regulation) may be accessed 
through FOIA.  It is important for applicants to understand the basic scope 
of this amendment.  NIH has provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application should 
include a description of the archiving plan in the study design and include 
information about this in the budget justification section of the 
application. In addition, applicants should think about how to structure 
informed consent statements and other human subjects procedures given the 
potential for wider use of data collected under this award.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION: The 
Department of Health and Human Services (DHHS) issued final modification to 
the “Standards for Privacy of Individually Identifiable Health Information”, 
the “Privacy Rule,” on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as “covered entities”) must do so by April 14, 2003 (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on “Am I a covered 
entity?”  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.   Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas. This 
RFA is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople. 

AUTHORITY AND REGULATIONS

This program is described in the Catalogue of Federal Domestic Assistance at 
http://www.cfda.gov/ in the following citations: No. 93.855, Immunology, 
Allergy, and Transplantation Research and No. 93.856, Microbiology and 
Infectious Diseases Research. Awards are made under authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and administered under NIH grants policies and Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92. This program is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The NIH Grants Policy Statement is available at 
http://grants.nih.gov/grants/policy/policy.htm. This document includes 
general information about the grant application and review process; 
information on the terms and conditions that apply to NIH Grants and 
cooperative agreements; and a listing of pertinent offices and officials at 
the NIH.  All awards are subject to the terms and conditions, cost 
principles, and other considerations described in the NIH Grants Policy 
Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free 
workplace and discourage the use of all tobacco products.  In addition, 
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in 
certain facilities (or in some cases, any portion of a facility) in which 
regular or routine education, library, day care, health care, or early 
childhood development services are provided to children.  This is consistent 
with the PHS mission to protect and advance the physical and mental health of 
the American people.


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NIH Funding Opportunities and Notices


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