COOPERATIVE CENTERS FOR TRANSLATIONAL RESEARCH ON HUMAN IMMUNOLOGY AND 
BIODEFENSE

RELEASE DATE:  August 19, 2003

RFA Number: RFA-AI-03-015 (Reissued as RFA-AI-08-014)

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: December 12, 2003 

APPLICATION RECEIPT DATE: January 13, 2004

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA

The National Institute of Allergy and Infectious Diseases (NIAID) invites 
applications from single institutions or consortia of institutions to increase 
the number of Cooperative Centers for Translational Research on Human 
Immunology and Biodefense originally established by NIAID in fiscal year 2003. 
The long-term goal of this program is the translation of research using animal 
models of immunity into clinical applications in humans. The immediate purpose 
is to support basic and translational research, and create the stable, 
flexible, centralized infrastructure needed to promote and coordinate 
multidisciplinary research in human immunology as it relates to defense 
against agents of bioterrorism and emerging/re-emerging infectious diseases. 
The program is milestone-based, and includes the flexibility to quickly 
redirect or replace research projects during the funding period. Funding 
beyond the first year will be contingent upon satisfactory progress in meeting 
negotiated milestones. The Cooperative Agreement mechanism (U19) will be used 
to support the development of multi-investigator teams with a scope of 
activities not possible with other funding mechanisms. Both basic and applied 
research topics are considered responsive. Although clinical research is the 
focus of this RFA, clinical trials are not allowed. For NIH definitions of 
clinical research and clinical trials, see 
http://grants.nih.gov/grants/funding/phs398/instructions2/p3_definitions.htm.

Each Center application will include six components: (1) an Overview section 
that summarizes the plans for the Center and the synergy to be attained by 
this multi-project, multidisciplinary approach; (2) a Research Project 
Component, to include a minimum of three Research Projects focused on 
understanding and/or modifying human immune response and regulation in the 
context of NIAID Category A, B, or C pathogens or their products (see list at 
http://www.niaid.nih.gov/biodefense/bandc_priority.htm); note that clinical 
trials, HIV research, and behavioral research will not be supported by this 
program; (3) a Technical Development Component to generate new or greatly 
improved assays, reagents, and technologies to advance more rapid and more 
definitive analyses of human immune responses; (4) a Core Facilities Component 
to support the Research Project and/or Technical Development Components by 
providing standard, existing assays, reagents, and/or technologies; note that 
an Administrative Core Facility is required within this Component; (5) a Pilot 
Project Component to foster innovative research on NIAID Category A-C 
pathogens; and (6) an Education Component focused on short term training in 
the technical or theoretical aspects of human immunology research and 
biodefense.

Synergistic interaction is a key feature of this program. Each Center will 
provide unique and complementary strengths in terms of technical potential and 
specific areas of immunological investigation, and all Centers will share 
responsibility for program development and resource coordination via a single 
Centers Steering Committee. This Committee was established with the award of 
Center grants in fiscal year 2003, and it will be expanded in fiscal year 2004 
to include representatives from the new Centers awarded under this 
announcement.

RESEARCH OBJECTIVES

The definitive study of immune response and regulation is much more difficult 
to achieve in humans than in animal model systems. Not only are experimental 
approaches limited, but genetic and environmental heterogeneity make it much 
more difficult to obtain reproducible results. Although very talented and 
highly productive immunologists conduct animal studies that lead to rapid 
advances in fundamental knowledge and define tantalizing candidate approaches 
to the prevention or treatment of human disease, fewer researchers conduct 
immunological studies in humans. Many results obtained in animals do translate 
faithfully to humans, but some clearly do not. Therefore, research must also 
be conducted with human samples, to either verify findings or discover the 
relevant human pathways. This research program places a major focus on 
infrastructure support for technology development and accessibility to 
facilitate the translation from animal to human studies and to ultimately 
facilitate the translation of basic research into clinical applications.

Human studies must be based on assays that can generate reproducible and 
meaningful data, and that can be used by many research groups to form a 
reliable foundation of knowledge. Therefore, new or greatly improved 
technologies are needed to allow more definitive studies of immunological 
mechanisms, leading to more reliable clinical evaluation of disease progress, 
vaccine efficacy, or benefit of immune-based therapies.

The scientific focus of this Centers program is immune biodefense against 
infectious pathogens and their products, with primary emphasis on one or more 
of the NIAID Category A, B, or C pathogens or their products. Immune-based 
defenses against deliberately released or naturally occurring pathogens 
constitute very powerful weapons that complement drug-based approaches to 
control infectious disease. For example, safe and effective vaccine 
development will depend on better understanding of systemic and localized 
immune capacity, and of human variability at both the innate and adaptive 
levels of immunity and immunoregulation. Molecular mechanisms responsible for 
potent short-term immune responses and for long-term immune memory must be 
understood and optimized for new applications. Immune-based reagents, such as 
antibodies or defensins, should be developed for the passive protection of at-
risk civilian populations, and immune targets should be defined and tested to 
enhance immunomodulatory strategies. This program is expected to substantially 
support the NIAID biodefense effort by providing stable funding for immunology 
Centers focused on the translation of research from animals to humans.

Although clinical research is the focus of this RFA, clinical trials are not 
allowed. For NIH definitions of clinical research and clinical trials, see 
http://grants.nih.gov/grants/funding/phs398/instructions2/p3_definitions.htm.

The immediate goals of this program are to integrate and support the different 
components described below. The approximate weight that each component should 
receive in the budget, and will receive in the review, is indicated below as a 
percentage of the whole. Most emphasis is placed on the Research Projects and 
the Technical Development Components.

NOTE: Research Projects and Pilot Projects must include research on NIAID 
Category A, B, or C pathogens or their products. Such research may include, 
but is not limited to: molecular mechanisms of innate immunity; innate immune 
receptors as targets for adjuvant development; passive immunotherapy mediated 
by innate immune molecules, antibodies, or soluble receptors; mechanisms of 
synergy and regulation at the innate-adaptive immune interface; optimization 
of antimicrobial B and T cell effector mechanisms; antigen processing and 
presentation to T cells; antigen presenting cell functions; mechanisms of 
mucosal immunity; immunoregulation in the neonate or elderly; generation and 
maintenance of B and T cell memory; mechanisms of microbial immune evasion; 
and in vivo imaging of immune responses. 

NOTE: Specific instructions for organization of the application are described 
under the section below labeled "SPECIAL INSTRUCTIONS FOR COMPLETION OF 
APPLICATIONS IN RESPONSE TO THIS RFA: How to Organize the Application." An 
Overview section should be included in the application to describe the synergy 
to be gained by the multi-project structure. The proposed Center application 
must include the following components.

Research Project Component (40% weight)

Activities required: A minimum of three separate Research Projects focused on 
basic or applied immunology in the context of understanding, preventing, or 
treating NIAID Category A, B, or C pathogen-mediated human disease. Each 
project should address a common immunological theme such that synergy is 
evident among the projects.

Activities allowed: R01-type hypothesis-driven research and/or translational 
research that may be descriptive or applied. Applicants are strongly 
encouraged to include both basic researchers and those with clinical 
experience as project leaders, and to establish close collaborations between 
the basic and clinical scientists. Applicants with no history of research on 
the Category A-C pathogen(s) chosen for study are strongly encouraged to 
incorporate collaborators or consultants with documented expertise in the 
relevant research area. Animal studies are allowed, but only if they are 
clearly relevant to the human disease and only if plans are described for 
translating the results into studies on human cells or tissues within the 
five-year funding period. Multidisciplinary approaches are encouraged. Based 
on internal evaluations, as well as assessments made by the Centers Steering 
Committee (see below), replacement projects may be proposed at any time by the 
principal investigator for review and approval by the NIAID. Such replacement 
projects will not undergo additional peer review.

Activities not allowed: Clinical trials, HIV research, behavioral research, or 
animal studies that do not progress to human studies within the funding 
period.

Technical Development Component (40% weight)

Activities required: The discovery, validation, development, or 
standardization of specialized assays or methods, novel reagents, and/or 
technologies that will be of use to the research community for studies on 
human immunology. The application should include support for personnel with 
relevant documented expertise and sufficient effort dedicated to sustain a 
vigorous Technical Development program. A designated principal investigator is 
required for this component. The applicant should explain the value of the 
resources proposed for development. A plan must be proposed for periodic 
evaluation of scientific progress. Based on such internal evaluations, as well 
as assessments made by the Centers Steering Committee, replacement projects 
may be proposed at any time by the principal investigator of the Center for 
review and approval by the NIAID. Such replacement projects will not undergo 
additional peer review. When appropriate, new and/or improved assay, method, 
reagent, and technology protocols will be made publicly available. Scale-up 
plans for the production and distribution of any new reagents should be 
included in the application.

Activities allowed: One or several different Technology Development projects 
may be proposed. In the latter case, each different project should be 
presented as a separate Specific Aim within the research plan. The entire 
research plan (sections a-d of the PHS 398 form) for this component is limited 
to 40 pages total. The applicant should determine the number of Specific Aims 
to propose based on the scientific strength of each potential project balanced 
against the space limitations. For each Specific Aim, provide sufficient 
experimental detail, rationale, preliminary data, and discussion of potential 
problems and alternatives to allow reviewers to evaluate the proposed 
research. The Specific Aims need not be related to the scientific theme of the 
Research Projects. However, the applicant should provide compelling 
justification that the proposed research may provide useful tools to advance 
the study of human immunology. Technical development may include, but is not 
limited to:

o single cell assay development;
o techniques for improved high throughput screening;
o improved assays of immune effector function, such as antibody production, 
cytotoxic activity, or cytokine production;
o identification of biomarkers for specific immune responses;
o receptor repertoire analysis of responding T or B cells; 
o improved characterization of dendritic cells and other antigen presenting 
cells; and 
o in vivo imaging techniques.

Activities not allowed: Standard, existing assays, methods, reagents, 
technologies, or other currently available services; such activities should be 
proposed as Core Facilities.

Core Facility Component (10% weight)

Activities required: An Administrative Core is required for management of the 
Center program. The Administrative Core should include plans for organization, 
decision-making, and periodic evaluations within the program. It should also 
include plans for data sharing, protection of intellectual property, and 
involvement of institutional resources. An External Scientific Advisory 
Committee (ESAC) is also required, and should be described within the 
Administrative Core application. The duties and responsibilities of the ESAC 
should be clearly explained, and the budget request should include costs for 
meetings of ESAC members with Center personnel. HOWEVER, specific potential 
members of the proposed ESAC should not be named in the application and ESAC 
candidates should not be recruited or even contacted prior to review and 
award. A designated principal investigator is required for each Core Facility.

Activities allowed: Scientific Core Facilities may be proposed if they will be 
utilized by at least two of the Research Projects, or by a minimum of one 
Research Project and the Technical Development Component. Such Cores are 
limited to the provision of standard, existing assays, reagents, technologies, 
or other available services to the Center investigators. Scientific Cores 
should be well justified and clearly non-duplicative of other services or 
facilities available to the Center investigators. If replacement projects 
significantly change the use of such Cores, funds may be rebudgeted within the 
Center after approval by the NIAID. Cores may include clinical, statistical, 
technical (e.g., flow cytometry, proteomics), informatic, or other supportive 
activities. If appropriate to the particular Center, repositories for cells, 
tissues, reagents, or large data sets may be funded as Core Facilities. In 
this case, proposals should include methods to obtain, protect, and archive 
relevant clinical and family history information. In addition, appropriate 
informatics capability should be provided to track data and link to other data 
sets. A plan for the distribution of samples, reagents, data, and other 
resources should be included and should conform to the NIH policy on data and 
resource sharing 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).

Activities not allowed: Technical development is not allowed as a Core 
activity. All assay, method, reagent, or technology development should be 
proposed only in the Technical Development Component. Cores that are utilized 
only by one Research Project or only by the Technical Development Component 
are not allowed. Members of other Cooperative Centers for Translational 
Research on Human Immunology and Biodefense may not serve as members of an 
ESAC for a different Center.

Pilot Project Component (5% weight)

Activities required: A plan to support speculative studies of limited duration 
(six months to two years) and of limited budget ($50-100,000 direct costs per 
Pilot Project per year) must be included within the Center application. 
Applicants should provide a short description (two pages maximum per proposed 
Pilot Project) for two Pilot Projects proposed as examples only, to be used 
during the review of the Center application. These brief descriptions will 
serve to demonstrate the applicant's ability to conceptualize and design novel 
studies. Award of the Cooperative Agreement does not imply that these 
particular Pilot Projects will be implemented. The applicant must also 
describe the process by which requests for Pilot Project funds will be 
solicited, reviewed, and chosen within the Center, to be submitted for NIAID 
approval for actual implementation by that Center. In addition, the applicant 
must provide plans for tracking the success of the Center Pilot Project 
program; e.g., by following the number of projects that lead to independent 
R01 funding. A designated principal investigator must be proposed to manage 
this component.

Activities allowed: Pilot Projects that include collaborations between Centers 
will be encouraged in order to take advantage of specialized expertise and to 
promote further synergy within the Centers network. Any scientific topic 
focused on human immunology and Category A-C agents is allowed for a Pilot 
Project; the topic need not be closely related to the scientific theme of the 
Center's Research Projects. Applicants will be strongly encouraged to include 
non-Center members as investigators on Pilot Project awards, in order to 
expand expertise in human immunology research.

Activities not allowed: Equipment purchase.

Education Component (5% weight)

Activities required: The applicant must propose to fund at least one of the 
following activities, and must justify the choice of activity(s) in terms of 
educational value to the immunology research community: 

o train laboratory staff, postdoctoral fellows, or faculty members in the use 
of assays, methods, reagents, or technologies, to study human immunology in 
the context of biodefense;
o train such personnel in the principles of human immunology; however, formal 
courses will not be supported; and/or
o support a seminar series or symposia comprised of speakers invited from 
other institutions to present research results on the immunology of NIAID 
Category A-C infectious diseases.

Plans for the process to be used for selection of trainees, and for periodic 
internal evaluation of the Education Component, should be included in the 
application. A designated principal investigator must be proposed to manage 
this component.

Activities allowed: Applicants are strongly encouraged to include trainees 
from non-Center laboratories in addition to Center laboratories. Funds may be 
used for appropriate laboratory supplies and to compensate the effort of the 
facility personnel that provide the training. Funds may also be used to cover 
travel (such as will be needed to travel to annual meeting), housing, and per 
diem expenses, for a period up to two weeks, for non-government scientists 
from other domestic institutions to visit the Center to learn new techniques, 
Up to five visiting scientists may be supported per year in this manner. 

Activities not allowed: Formal courses will not be supported by these funds. 
In addition, funds may not be used to support the salaries or stipends of the 
trainees, or to purchase equipment.

MECHANISM OF SUPPORT

This RFA will use the NIH multi-project cooperative agreement (U19), an 
"assistance" mechanism, rather than an "acquisition" mechanism. The applicant 
will be solely responsible for planning, directing, and executing the proposed 
project. This RFA is a one-time solicitation. Future unsolicited, competing-
continuation applications based on this project will compete with all 
investigator-initiated applications and will be reviewed according to the 
customary peer review procedures. The anticipated award date is September 30, 
2004. 

Applications that are not funded in the competition described in this RFA may 
be resubmitted as NEW investigator-initiated applications using the standard 
receipt dates for NEW applications described in the instructions to the PHS 
398 application
 
The NIH U19 is a cooperative agreement award mechanism in which the Principal 
Investigator retains the primary responsibility and dominant role for 
planning, directing, and executing the proposed project, with NIH staff being 
substantially involved as a partner with the Principal Investigator, as 
described under the section "Cooperative Agreement Terms and Conditions of 
Award". 

The total project period for applications submitted in response to this RFA 
may not exceed five years.

This RFA uses just-in-time concepts. It also uses the modular as well as the 
non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm). Specifically, if 
the investigator is submitting an application with direct costs in each year 
of $250,000 or less, use the modular format. Otherwise follow the instructions 
for non-modular research grant applications. This program does not require 
cost sharing as defined in the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

Applicants for U19 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.

FUNDS AVAILABLE 

The NIAID intends to commit approximately $15M in FY 2004 to fund 4 to 5 new 
grants in response to this RFA. An applicant may request a project period of 
up to 5 years and a budget for direct costs of up to $2M per year. Because the 
nature and scope of the proposed research will vary from application to 
application, it is anticipated that the size and duration of each award will 
also vary. Although the financial plans of the NIAID provide support for this 
program, awards pursuant to this RFA are contingent upon the availability of 
funds and the receipt of a sufficient number of meritorious applications.  

Funds may not be used for renovations or alterations.

At this time, the NIAID has not determined whether or how this solicitation 
will be continued beyond the present RFA.

ELIGIBLE INSTITUTIONS

The applicant may submit (an) application(s) if the institution has any of the 
following characteristics:

o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges, hospitals, 
and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic 
o Faith-based or community-based organizations 

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS

Any individual with the skills, knowledge, and resources necessary to carry 
out the proposed research is invited to work with their institution to develop 
an application for support. Individuals from underrepresented racial and 
ethnic groups as well as individuals with disabilities are always encouraged 
to apply for NIH programs.

SPECIAL REQUIREMENTS

Milestones of Progress

Applications must describe yearly milestones for each Center, to include 
timelines for the operation of each component, and scientific milestones for 
the Research Project and Technical Development Components. NIAID encourages 
applicants to present explicit, quantitative milestones. It is recognized that 
milestones may require revision and re-negotiation during the course of the 
project period. Release of each yearly funding increment by NIAID will be 
based on a NIAID review of progress towards achieving the previously agreed 
upon milestones.

Centers Steering Committee

In fiscal year 2003, the NIAID established a Centers Steering Committee to 
serve as the governing body of the Cooperative Centers for Translational 
Research on Human Immunology and Biodefense. The Steering Committee is, and 
will be, composed of the principal investigators of each of the U19 grants 
awarded in fiscal years 2003 and 2004, plus the NIAID Scientific Coordinator. 
Each member of the Steering Committee has one vote. The Steering Committee or 
the NIAID may identify and appoint other members, as appropriate. A 
Chairperson is selected by the Steering Committee from among the non-federal 
Committee members. Subcommittees of the Steering Committee may be established 
as necessary. The Steering Committee will meet 2 times per year, including the 
meeting in conjunction with the Annual Workshop (see below). Proposed budgets 
should include funds to cover travel costs for these meetings. Each Steering 
Committee member will be expected to participate in all meetings and 
activities, e.g., conference calls and special subcommittees, as may be 
necessary for optimal operation of the Cooperative Centers for Translational 
Research on Human Immunology and Biodefense.

The Steering Committee will be responsible for: promoting synergistic 
interactions within each Center and among the Centers; evaluating the use of 
Education Components; evaluating plans for the redirection of ongoing projects 
for NIAID approval; developing a policy on publication and sharing of data 
obtained by the collaborative efforts of the Centers; and recommending the 
incorporation of additional expertise or research resources. Separate funds 
will be available to the Steering Committee to support the Cooperative 
Resources deemed necessary.

Annual Workshop

Principal investigators will be expected to participate in an annual workshop 
organized by the Centers Steering Committee in order to: share both positive 
and negative results with other Centers; share materials including reagents 
and techniques; assess progress; identify new research opportunities; and 
establish research priorities and collaborations that will maximize the impact 
of the program to improve human vaccines and immunotherapies for biodefense. 
Therefore, travel funds for the principal investigator and other selected 
Center investigators and collaborators should be budgeted for this purpose. A 
Centers Steering Committee meeting will also be held in conjunction with the 
annual workshop.

Intellectual Property Rights

Institutions' rights in inventions made under this funding mechanism and the 
reporting requirements for such inventions will be governed by Public Law 96-
517 (the Bayh-Dole Act of 1980), 35 U.S.C. Secs. 200-212, 37 C.F.R. Part 401, 
and 45 C.F.R. parts 6 and 8. Institutions and investigators are expected to 
share background technology and intellectual property on a non-exclusive and 
royalty-free basis with other participating institutions as required to carry 
out the aims of the collaborative projects. In the event of a joint invention 
involving multiple institutions, the co-inventors' institutions are expected 
to cooperate in the filing of any resulting patent applications and in 
developing a plan to achieve commercial application of the technology. 
Applicants are expected to abide by the "Principles and Guidelines for 
Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating 
Biomedical Research Resources," as published in the Federal Register December 
23, 1999, Volume 64, Number 246, Pages 72090-72096. The Centers Steering 
Committee will be asked to develop a policy on publication and sharing of data 
obtained by the collaborative efforts of the Cooperative Centers for 
Translational Research on Human Immunology and Biodefense.

Cooperative Resources

The Centers Steering Committee may establish and support Cooperative Resources 
that provide central assistance and technical expertise for projects 
undertaken by Center investigators under this program. Examples include 
genomic/proteomic, tetramer, or sophisticated flow cytometry facilities. The 
Centers Steering Committee will determine procedures for the designation of 
such Cooperative Resources, and will determine the scope of work and level of 
support based on Center priorities and requirements. Non-administrative Core 
Facilities proposed by individual Centers may be expanded to become 
Cooperative Resources using the separate funds available to the Centers 
Steering Committee. Cooperative Resources may be housed at particular Centers 
or may be supported through subcontracts to other facilities.

Cooperation with Other NIH-Sponsored Programs

In order to most efficiently utilize research resources and rapidly exchange 
scientific information to promote biodefense objectives, the Cooperative 
Centers for Translational Research on Human Immunology and Biodefense will 
coordinate their efforts with other NIH-funded programs, including but not 
limited to the following NIAID programs: Regional Centers of Excellence for 
Biodefense and Emerging Infectious Diseases Research, Vaccine and Treatment 
Evaluation Units, Biodefense and Emerging Infections Research Resource 
Program, Tetramer Facility, Respiratory Pathogens Network, Food and Waterborne 
Diseases Integrated Research Network, Immune Tolerance Network, and 
International Histocompatibility Working Group.

COOPERATIVE AGREEMENT TERMS AND CONDITIONS OF AWARD

The following terms and conditions will be incorporated into the award 
statement and provided to the Principal Investigator as well as the 
institutional official at the time of award.

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 part 74 and 92, and other HHS, PHS, and NIH Grant Administration 
policy statements.

The administrative and funding instrument used for this program is the 
multiproject cooperative agreement (U19), an "assistance", rather than an 
"acquisition", mechanism, in which substantial NIH scientific and/or 
programmatic involvement with the awardee is anticipated during the 
performance of the activity. Under the cooperative agreement, the NIH purpose 
is to support and/or stimulate the recipient's activity by involvement in and 
otherwise working jointly with the award recipient in a partner role, but it 
is not to assume direction, prime responsibility, or a dominant role in the 
activity. Consistent with this concept, the dominant role and prime 
responsibility for the activity resides with the awardees for the project as a 
whole, although specific tasks and activities in carrying out the research 
will be shared among the awardees and the NIAID Scientific Coordinator.

1. Monitoring Clinical Studies

When clinical studies 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 defining the research 
objectives, approaches and details of the projects within the guidelines of 
the RFA and for performing the scientific activity. Specifically, awardees 
have primary responsibility as described below.

Milestones of Progress

Applicants must describe yearly milestones for each Center, to include 
timelines for the operation of each component, and scientific milestones for 
the Research Project and Technical Development Components. NIAID encourages 
applicants to present explicit, quantitative milestones. It is recognized that 
milestones may require revision and re-negotiation during the course of the 
project period. Release of each yearly funding increment by NIAID will be 
based on a NIAID review of progress towards achieving the previously agreed 
upon milestones.

Annual Workshop

Principal investigators will be expected to participate in an annual workshop 
organized by the Centers Steering Committee in order to: share both positive 
and negative results with other Centers; share materials including reagents 
and techniques; assess progress; identify new research opportunities; and 
establish research priorities and collaborations that will maximize the impact 
of the program to improve human vaccines and immunotherapies for biodefense. A 
Centers Steering Committee meeting will also be held in conjunction with the 
annual workshop.

Intellectual Property Rights

Institutions' rights in inventions made under this funding mechanism and the 
reporting requirements for such inventions will be governed by Public Law 96-
517 (the Bayh-Dole Act of 1980), 35 U.S.C. Secs. 200-212, 37 C.F.R. Part 401, 
and 45 C.F.R. parts 6 and 8. Institutions and investigators are expected to 
share background technology and intellectual property on a non-exclusive and 
royalty-free basis with other participating institutions as required to carry 
out the aims of the collaborative projects. In the event of a joint invention 
involving multiple institutions, the co-inventors' institutions are expected 
to cooperate in the filing of any resulting patent applications and in 
developing a plan to achieve commercial application of the technology. 
Awardees are expected to abide by the "Principles and Guidelines for 
Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating 
Biomedical Research Resources," as published in the Federal Register December 
23, 1999, Volume 64, Number 246, Pages 72090-72096. The Centers Steering 
Committee will develop a policy on publication and sharing of data obtained by 
the collaborative efforts of the Cooperative Centers for Translational 
Research on Human Immunology and Biodefense.

Cooperation with Other NIH-Sponsored Programs

In order to most efficiently utilize research resources and rapidly exchange 
scientific information to promote biodefense objectives, the Cooperative 
Centers for Translational Research on Human Immunology and Biodefense will 
coordinate their efforts with other NIH-funded programs, including but not 
limited to the following NIAID programs: Regional Centers of Excellence for 
Biodefense and Emerging Infectious Diseases Research, Vaccine and Treatment 
Evaluation Units, Biodefense and Emerging Infections Research Resource 
Program, Tetramer Facility, Respiratory Pathogens Network, Food and Waterborne 
Diseases Integrated Research Network, Immune Tolerance Network, and 
International Histocompatibility Working Group.

3. NIAID Staff Responsibilities

NIAID staff assistance will be provided by a Program Officer from the Basic 
Immunology Branch of the Division of Allergy, Immunology, and Transplantation 
who will serve as NIAID's Scientific Coordinator. The NIAID Scientific 
Coordinator will have substantial scientific/programmatic involvement during 
the conduct of this activity through technical assistance, advice and 
coordination above and beyond normal program stewardship for grants. As 
indicated above, the NIAID Scientific Coordinator will be a voting member of 
the Centers Steering Committee.

During performance of the award, the NIAID Scientific Coordinator, with 
assistance from other scientific program staff who are designated based on the 
research topic and their relevant expertise, may provide appropriate 
assistance, advice, and guidance by: participating in the design of the 
activities; advising in the selection of sources or resources (e.g., 
determining where a particular reagent can be found); coordinating or 
participating in the collection and/or analysis of data; advising in 
management and technical performance; or participating in the preparation of 
publications. The NIAID Scientific Coordinator will serve as a 
liaison/facilitator between the awardee, pharmaceutical and biotech 
industries, and other government agencies (e.g., FDA, USDA, CDC) and will 
serve as a resource of scientific and policy information related to the goals 
of the awardee's research. However, the role of NIAID will be to facilitate 
and not to direct the activities. It is anticipated that decisions in all 
activities will be reached by consensus and the NIAID staff will be given the 
opportunity to offer input into this process. The manner of reaching this 
consensus and the final decision-making authority will rest with the Principal 
Investigator.

An NIAID Program Official will be assigned to perform normal program 
stewardship responsibilities for this award. The Program Official may serve as 
the Scientific Coordinator. 

The NIAID Program Director will: 

o  Approve changes in proposed milestones of progress, approve proposed Pilot 
Projects, and approve redirection of Research Projects or Research Resource 
Technical Development components;

o  Review progress through consideration of annual progress reports and 
periodic reports on ongoing progress, findings, and future plans presented 
during meetings and conference calls, publications, site visits, etc.; and 

o  Together with the NIAID Grants Management Specialist, approve changes in 
the Principal Investigator of the U19 grant, or changes in the Principal 
Investigator of a Research Resource Technical Development or Research Project 
component.

4. Collaborative Responsibilities

Centers Steering Committee

In fiscal year 2003, the NIAID established a Centers Steering Committee to 
serve as the governing body of the Cooperative Centers for Translational 
Research on Human Immunology and Biodefense. The Steering Committee is, and 
will be, composed of the principal investigators of each of the U19 grants 
awarded in fiscal years 2003 and 2004, plus the NIAID Scientific Coordinator. 
Each member of the Steering Committee has one vote. The Steering Committee or 
the NIAID may identify and appoint other members, as appropriate. A 
Chairperson is selected by the Steering Committee from among the non-federal 
Committee members. Subcommittees of the Steering Committee may be established 
as necessary. The Steering Committee will meet 2 times per year, including the 
meeting in conjunction with the Annual Workshop.  Each Steering Committee 
member will be expected to participate in all meetings and activities, e.g., 
conference calls and special subcommittees, as may be necessary for optimal 
operation of the Cooperative Centers for Translational Research on Human 
Immunology and Biodefense.

The Steering Committee will be responsible for: promoting synergistic 
interactions within each Center and among the Centers; evaluating the use of 
Education Components; evaluating plans for the redirection of ongoing projects 
for NIAID approval; developing a policy on publication and sharing of data 
obtained by the collaborative efforts of the Centers; and recommending the 
incorporation of additional expertise or research resources. Separate funds 
will be available to the Steering Committee to support the Cooperative 
Resources deemed necessary.

Cooperative Resources

The Centers Steering Committee may establish and support Cooperative Resources 
that provide central assistance and technical expertise for projects 
undertaken by Center investigators under this program. Examples include 
genomic/proteomic, tetramer, or sophisticated flow cytometry facilities. The 
Centers Steering Committee will determine procedures for the designation of 
such Cooperative Resources, and will determine the scope of work and level of 
support based on Center priorities and requirements. Non-administrative Core 
Facilities proposed by individual Centers may be expanded to become 
Cooperative Resources using the separate funds available to the Centers 
Steering Committee. Cooperative Resources may be housed at particular Centers 
or may be supported through subcontracts to other facilities.

Cooperation with Other NIH-Sponsored Programs  

In order to most efficiently utilize research resources and rapidly exchange 
scientific information to promote biodefense objectives, the Cooperative 
Centers for Translational Research on Human Immunology and Biodefense will 
coordinate their efforts with other NIH-funded programs, including but not 
limited to the following NIAID programs: Regional Centers of Excellence for 
Biodefense and Emerging Infectious Diseases Research, Vaccine and Treatment 
Evaluation Units, Biodefense and Emerging Infections Research Resource 
Program, Tetramer Facility, Respiratory Pathogens Network, Food and Waterborne 
Diseases Integrated Research Network, Immune Tolerance Network, and 
International Histocompatibility Working Group.

5. Arbitration

Any disagreement that may arise on scientific or programmatic matters (within 
the scope of the award), between award recipients and the NIAID may be brought 
to arbitration. An arbitration panel will be composed of three members - one 
selected by the Steering Committee (with the NIAID representation not voting) 
or by the individual awardee in the event of an individual disagreement, a 
second member selected by NIAID, and the third member selected by the two 
prior selected members. This special arbitration procedure in no way affects 
the awardee's right to appeal an adverse action that is otherwise appealable 
in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS 
regulation at 45 CFR Part 16.

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity to 
answer questions from potential applicants. Inquiries may fall into three 
areas: scientific/research, peer review, and financial or grants management 
issues:

o Direct questions about scientific/research issues to:

Helen Quill, Ph.D.
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases
Room 3013, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 496-7551
FAX: 301-480-2381
Email: hq1t@nih.gov

o Direct questions about peer review issues to:

Priti Mehrotra, Ph.D.
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases
Room 2100, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
Telephone: (301) 435-9369
FAX: 301-402-2638 
Email: pm158b@nih.gov

o Direct questions about financial or grants management matters to:

Ann Devine
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases
Room 2118, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 402-5601
FAX: (301) 480-3780
Email: ad22x@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, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
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 a subsequent application, the information that it 
contains allows IC staff to estimate the potential review workload and plan 
the review.

The letter of intent is to be sent by the date listed at the beginning of this 
document. The letter of intent should be sent to:

Priti Mehrotra, Ph.D.
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases
Room 2100, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616

SUBMITTING AN APPLICATION

Applicants for U19 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.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) 
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
Bethesda, MD 20817 (for express/courier service)

At the time of submission, two additional exact copies of the grant 
application and all five sets of any appendix material must be sent to:

Priti Mehrotra, Ph.D.
Division of Extramural Activities 
National Institute of Allergy and Infectious Diseases
Room 2100, MSC-7616
6700-B Rockledge Drive
Bethesda, MD 20892-7616
BETHESDA, MD 20817-7616 [for express mail/courier service]

Applications that are not received as a single package on or before January 
13, 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.

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 U19 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.

How to Organize the Application

The application must be organized as indicated below, with strict adherence to 
the page limits. Applicants are encouraged to use fewer than the maximum pages 
allowed when possible. Each section of the application must be presented in 
the sequence indicated below.

(1) Overview section. Follow the INSTRUCTIONS FOR APPLICATIONS FOR MULTI-
PROJECT AWARDS to prepare this first section. Explain here how the different 
Research Projects and Core Facilities will function synergistically to achieve 
results not possible if funded individually. Also explain how the proposed 
research program will help develop new technologies for the study of human 
immunology. Describe how any proposed consortia will become integral 
components of the program, especially if they are at a geographically distant 
location. Provide sufficient detail to allow reviewers to assess the 
likelihood that appropriate interactions will indeed be frequent, substantive, 
and productive. Explain the leadership and scientific qualifications of the 
individual principal investigators within the program, as well as the 
principal investigator of the entire Center. Describe the Milestones of 
Progress proposed for the program. Also provide details of institutional 
commitment to this Centers program, and describe any additional institutional 
resources that add value to the program, such as university core facilities or 
cost-sharing of equipment purchase by the applicant institution. Letters of 
support from institutional personnel that outline institutional commitment to 
the program should be attached at the end of this section of the application. 
The composite budget for the entire Center program is also included within 
this section. NOTE that the narrative text of this section (items a-d of the 
PHS 398 form) is limited to 25 pages maximum.

(2) Research Project Component (40% weight). Prepare each of the individual 
Research Project applications as described in the INSTRUCTIONS FOR 
APPLICATIONS FOR MULTI-PROJECT AWARDS. Number and present each Research 
Project in sequence. Each project application should include its own budget 
pages. Be sure to include a discussion in each project of its inter-
relationship with the other projects. Any letters of collaboration should be 
attached at the end of the relevant individual project application. NOTE that 
the research plan (sections a-d of the PHS 398 form) is limited to 25 pages 
maximum for each Research Project.

(3) Technical Development Component (40% weight). Describe this component in a 
single application, limited to 40 pages maximum for the research plan 
(sections a-d of the PHS 398 form). A principal investigator with 
responsibility for the entire Technical Development Component must be 
proposed. If more than one project is proposed, describe each as a separate 
Specific Aim. If consortia are involved, prepare the budget pages as described 
in the PHS 398 form instructions. Do not include standard assays, methods, 
technologies, or services in this section; propose only new or significant 
improvements that require substantial investment in development. Any letters 
of collaboration should be attached at the end of the relevant individual 
application. NOTE that the research plan (sections a-d of the PHS 398 form) is 
limited to 40 pages maximum for this entire component.

(4) Core Facilities (10% weight). Prepare each of the individual Core Facility 
applications as described in the INSTRUCTIONS FOR APPLICATIONS FOR MULTI-
PROJECT AWARDS. Present the required Administrative Core Facility application 
first, followed by optional scientific Core Facility applications. The 
Administrative Core application should include discussion of how the program 
will be coordinated, evaluated, and managed; as well as discussion of the 
External Scientific Advisory Committee (without names of potential members), 
the data sharing plan, any intellectual property issues, and plans to maintain 
and expand institutional commitment to the program. Scientific Core Facilities 
are limited to the provision of standard assays, methods, technologies, or 
services to the Center investigators to support the Research Projects and/or 
Technical Development Components. Describe explicitly how each Core will 
provide value to particular Components of the program. Do not include 
technology development proposals in this section. Each Core application should 
include its own budget pages. Any letters of collaboration should be attached 
at the end of the relevant individual application. NOTE that the research plan 
(sections a-d of the PHS 398 form) is limited to 25 pages maximum for each 
Core application.
 
(5) Pilot Project Component (5% weight). Prepare a single application that 
includes a principal investigator for the component, plus budget pages, etc. 
Include two examples of potential Pilot Projects, with each example described 
within 2 pages maximum. In addition, discuss the methods by which the Pilot 
Projects will be chosen for funding within the Center, and the methods by 
which the success of funded Pilot Projects will be evaluated and tracked over 
the life of the Center grant. NOTE that the research plan (sections a-d of the 
PHS 398 form) is limited to 25 pages maximum for this component.

(6) Education Component (5% weight). Prepare a single application that 
includes a principal investigator for the component, plus budget pages, etc. 
Discuss the methods by which non-Center investigators or trainees will be 
chosen as participants, in addition to Center personnel. Describe the process 
for choosing participants for any proposed symposia or seminar series. NOTE 
that the research plan (sections a-d of the PHS 398 form) is limited to 25 
pages maximum for this component.

(7) Biographical sketches of all professional personnel. First present the 
biographical sketch of the Center principal investigator, followed by those of 
other key personnel in alphabetical order. 

(8) Checklist. Place the checklist for the entire application at the end of 
the package.

(9) Appendix. For the entire application, the Appendix is limited to a total 
of 10 documents or 100 pages, whichever is less. Scientific manuscripts are 
limited to those that are published or are in press at the time the 
application is submitted.

APPLICATION PROCESSING: Applications must be received by 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. 
However, when a previously unfunded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application. That is the application for the RFA 
must not include an Introduction describing the changes and improvements made, 
and the text must not be marked to indicate the changes. While the 
investigator may still benefit from the previous review, the RFA application 
is not to state explicitly how.

Concurrent submission of an R01 and a Component Project of a Multi-project 
Application: Current NIH policy permits a component research project of a 
multi-project grant application to be concurrently submitted as a traditional 
individual research project (R01) application. If, following review, both the 
multi-project application and the R01 application are found to be in the 
fundable range, the investigator must relinquish the R01 and will not have the 
option to withdraw from the multi-project grant. This is an NIH policy 
intended to preserve the scientific integrity of a multi-project grant, which 
may be seriously compromised if a strong component project(s) is removed from 
the program. 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.

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 and/or non-responsive applications 
will be returned to the applicant without further consideration.

Applications that are complete and responsive to the RFA will be evaluated for 
scientific and technical merit by an appropriate peer review group convened by 
the NIAID in accordance with the review criteria stated below. As part of the 
initial merit review, all applications will:

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

REVIEW CRITERIA

The general review criteria for U19 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, the following review criteria, will 
be considered in the determination of scientific merit and the priority score:

(1) Organization and Scientific Potential of the Center

(a) Adequacy of the applicant's plan to establish, coordinate, and manage a 
synergistic research program to achieve the goals of the Cooperative Centers 
for Translational Research on Human Immunology and Biodefense.
(b) Sufficient focus on human immunology and assay, method, reagent, and 
technology development. 
(c) Scientific/technical merit and innovation of the proposed goals of the 
Center.
(d) Expertise and productivity of proposed Center investigators.
(e) Potential of the proposed Center to develop critical new knowledge about 
the immunology of Category A-C biodefense and emerging infectious diseases.
(f) Merit and appropriateness of the documented institutional support to the 
goals of the Center.

(2) Research Project Component (40% weight)

(a) Adequacy of the applicant's plans to conduct synergistic basic and/or 
applied research on Category A-C pathogens to discover fundamentally new 
principles of human immunity and/or promote the most rapid progress in 
achieving applications for human protection.
(b) Technical feasibility of plans to conduct studies with human samples or to 
translate results from animal work into the human.

(3) Technical Development Component (40% weight)

Scientific and logistical adequacy of the plans to develop, validate, and 
disseminate new assays, methods, reagents, and technologies for the timely and 
optimal study of human immunology for biodefense.

(4) Core Facilities Component (10% weight)

(a) Appropriateness of the Center management and decision-making plans.
(b) Appropriateness of the functions described for the External Scientific 
Advisory Committee.
(c) Appropriateness of the proposed Core facilities in the context of the 
overall research plan of the Center application and the context of currently 
available facilities.
(d) Feasibility and clarity of plans for prioritizing the use of facilities by 
Center members.
(e) Use of Core facilities to conserve resources for common tasks such as MHC 
typing, microarray gene or protein expression assays, or flow cytometry.

(5) Pilot Project Component (5% weight)

(a) Scientific strengths of the two proposed examples of Pilot Projects in the 
context of human immunology and Category A-C agents.
(b) Adequacy, fairness, and scientific basis of the applicant's plans to 
propose Pilot Projects for implementation.
(c) Plans to monitor success of the Pilot Projects in terms of subsequent 
independent funding obtained to develop the projects begun as pilots.

(6) Education Component (5% weight)

(a) Adequacy of the plans to select and train laboratory staff, postdoctoral 
fellows, faculty members, and scientists who are not Center members in the use 
of assays, methods, reagents, and technologies to study human immunology in 
the context of biodefense.
(b) Appropriateness of plans to support seminar series/symposia, if proposed.

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 CONSIDERATIONS

DATA SHARING: The adequacy of the proposed plan to share data.

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:      December 12, 2003
Application Receipt Date:           January 13, 2004
Scientific Peer Review Date:        May, 2004
Advisory Council Review:            September, 2004
Earliest Anticipated Start Date:    September 30, 2004

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Programmatic priorities

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

MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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://stemcells.nih.gov/registry/). 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 PA 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.the context of currently 
available facilities.
(d) Feasibility and clarity of plans for prioritizing the use of facilities by 
Center members.
(e) Use of Core facilities to conserve resources for common tasks such as MHC 
typing, microarray gene or protein expression assays, or flow cytometry.

(5) Pilot Project Component (5% weight)

(a) Scientific strengths of the two proposed examples of Pilot Projects in the 
context of human immunology and Category A-C agents.
(b) Adequacy, fairness, and scientific basis of the applicant's plans to 
propose Pilot Projects for implementation.
(c) Plans to monitor success of the Pilot Projects in terms of subsequent 
independent funding obtained to develop the projects begun as pilots.

(6) Education Component (5% weight)

(a) Adequacy of the plans to select and train laboratory staff, postdoctoral 
fellows, faculty members, and scientists who are not Center members in the use 
of assays, methods, reagents, and technologies to study human immunology in 
the context of biodefense.
(b) Appropriateness of plans to support seminar series/symposia, if proposed.

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 CONSIDERATIONS

DATA SHARING: The adequacy of the proposed plan to share data.

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:      December 12, 2003
Application Receipt Date:           January 13, 2004
Scientific Peer Review Date:        May, 2004
Advisory Council Review:            September, 2004
Earliest Anticipated Start Date:    September 30, 2004

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit of the proposed project as determined by peer review
o Availability of funds
o Programmatic priorities

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

MONITORING PLAN AND DATA AND SAFETY MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

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://stemcells.nih.gov/registry/). 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 PA 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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