COOPERATIVE CENTERS FOR TRANSLATIONAL RESEARCH ON HUMAN IMMUNOLOGY AND 
BIODEFENSE

RELEASE DATE:  September 16, 2002

RFA: AI-02-042

National Institute of Allergy and Infectious Diseases  (NIAID) 
 (http://www.niaid.nih.gov)

LETTER OF INTENT RECEIPT DATE: December 20, 2002 
APPLICATION RECEIPT DATE: January 22, 2003 

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanisms 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 
establish Cooperative Centers for Translational Research on Human Immunology 
and Biodefense. The long-term goal of this program is the translation of 
research using animal models of immunity to infection into clinical 
applications in humans. The immediate purpose is to support stable, flexible, 
centralized infrastructure and research needed to promote and coordinate 
multidisciplinary basic and clinical research in human immunology as it 
relates to defense against agents of bioterrorism and emerging/re-emerging 
infectious diseases. The program will be milestone-based, and will include 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), together with the Exploratory Planning Grant 
mechanism (R21), will be used to support the development of multi-investigator 
teams with a scope of activities not possible with other funding mechanisms.

Each Center will consist of at least five components: (1) Research Resource 
Technical Development of assays, reagents, and technologies to advance more 
rapid and more definitive analyses of human immune responses, (2) a minimum of 
three Research Projects focused on understanding human immune response and 
regulation in the context of NIAID Category A-C pathogens or their 
products (see list at 
http://www2.niaid.nih.gov/Biodefense/bandc_priority.htm),note that 
clinical trials, HIV research, and behavioral research will not be supported 
by this program, (3) Core Facilities to support the research projects or to 
facilitate management of the Center, (4) short-term Pilot Projects, and (5) 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 Centers 
Steering Committee. Applicants must include research projects that address a 
central theme of immunological interest in the context of biodefense, as well 
as describe the unique technical expertise offered for the development and 
utilization of assays, reagents, and technologies. 

All applicants must comply with the requirements outlined in the section below 
entitled "SPECIAL REQUIREMENTS."

RESEARCH OBJECTIVES

Background

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 many 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 the human. Many results obtained in animals do 
translate faithfully in the human, but some clearly do not. Therefore, 
research must also be conducted with human samples, to either verify findings 
or discover the relevant human pathways. A research program with a primary 
focus on infrastructure support for technology development and accessibility 
will help to open the bottleneck of human research and 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 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. Immune-based defenses against 
deliberately released or naturally occurring pathogens constitute very 
powerful weapons that complement drug-based approaches to control infectious 
disease. 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 
populations, and immune targets should be defined and tested to enhance 
immunomodulatory strategies. This program is expected to substantially support 
the biodefense effort by providing stable funding for immunology Centers 
focused on the translation from animal to human research.
Research Objectives and Scope

The ultimate goal of this program is to facilitate the discovery and 
translation of immunological knowledge into new strategies to prevent and 
treat infectious disease in humans. The immediate goals are to support (1) 
Research Resource Technical Development via sufficient infrastructure for the 
development of reagents, assays, and technologies for human immunology 
research, (2) a minimum of three Research Projects per Center focused on 
immunity to NIAID Category A-C pathogens or their products, (3) Core 
Facilities to enhance research activities, (4) Pilot Projects for innovative 
research, and (5) Education of research personnel in new technology or 
principles of human immunology. Each of these essential program components is 
discussed in more detail below. The approximate weight that each component 
should receive is indicated as a percentage of the annual direct costs to be 
proposed. These values are provided as guidance, significant exceptions may be 
proposed, but should be well justified. Components of the Center may be 
located solely at the parent institution or may be included through 
collaborative associations with investigators at other institutions.

(1) Research Resource Technical Development Component (40%)
Applications must include a dedicated component for the identification, 
validation, development, standardization, dissemination and/or economization 
of specialized assays, reagents, and technologies of use to the research 
community for human studies in immunology. Resource development may include, 
but is not limited to: improved high throughput rapid screening techniques, 
single cell assay development, improved assays of immune effector function, 
such as antibody production, cytotoxic activity, or cytokine production, 
characterization and function of dendritic cells and other antigen presenting 
cells, identification of biomarkers for specific immune responses, receptor 
repertoire analysis of responding T or B cells, and in vivo imaging 
techniques. This component should include support for personnel with relevant 
documented expertise and sufficient effort dedicated to sustain a vigorous 
resource development program. Funds for general supplies and specialized 
reagents should also be requested. Scale-up plans for the production and 
distribution of new reagents should be included. The applicant should explain 
the value of the resources proposed for development, both within the context 
of other resources currently available to Center investigators, and of 
resources available to the general immunology research community. 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 (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. When appropriate, new and/or 
improved assay, reagent, and technology protocols will be made publicly 
available.

(2) Research Project Component (40%)
This program will not support clinical trials, HIV research, and behavioral 
research. Basic or applied research projects must focus on immunology research 
in the context of the prevention or treatment of NIAID category A-C pathogen-
mediated disease. A minimum of three research projects is required. 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. 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. Each project should address a common scientific theme such that 
synergy is evident. A plan must be proposed for periodic evaluation of 
scientific progress. For projects that include animal studies, the potential 
to begin studies in humans must be evaluated periodically. Based on such 
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.

(3) Core Facility Component (10%)
Facilities to support the Research Projects and/or to facilitate management of 
the Center and interactions among the Centers may be proposed if they will be 
utilized by at least two of the Research Projects, by the Research Resource 
Technical Development Component plus at least one of the Research Projects, or 
by the Principal Investigator for administration of the program. Such core 
facilities should be well justified and clearly non-duplicative of other 
facilities or services available to the Center investigators. If replacement 
projects significantly change the use of such facilities, funds may be 
rebudgeted within the Center after approval by the NIAID. Facilities may 
include administrative, clinical, statistical, technical (e.g., flow 
cytometry, proteomics), or other supportive activities. If appropriate to the 
particular Center, repositories for cells, tissues, or reagents may be funded 
under this component. In this case, proposals should include methods to 
obtain, protect, and archive relevant pathological, 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 distribution of 
samples should also be included and should conform to the NIH policy on data 
and resource sharing (http://www.nih.gov/science/models/sharing.html).

(4) Pilot Project Component (5%)
In order to take maximum advantage of new research opportunities, to provide 
support for high-risk, high-impact ideas, and to promote collaborations, 
applicants should include examples of two pilot projects to support 
feasibility studies likely to lead to independent R01 funding. The research 
proposed should focus on NIAID Category A-C agents. This component is intended 
to provide additional flexibility to the program and will support studies of 
limited duration (six months to two years) and of limited budget ($50-100,000 
direct costs per pilot project per year). These funds may not be used for 
equipment purchase. Applicants should provide a short description of two 
proposed pilot projects as examples to be used during the review of the Center 
application. The description should be covered in three pages or less, and 
will serve to demonstrate the applicant"s capabilities to conceptualize and 
design novel studies. Award of the Cooperative Agreement does not imply that 
these particular proposed pilot projects will be implemented. In the 
application, the Principal Investigator should describe a process for the 
proposal, review, and selection of the actual pilot projects to be submitted 
for NIAID approval for implementation by that Center. Pilot projects that 
include collaborations between Centers will be encouraged in order to take 
advantage of specialized expertise and to promote further synergy. 

(5) Education Component (5%)
The applicant should include plans to train laboratory staff, postdoctoral 
fellows, or faculty members in the use of assays, reagents, or technologies to 
study human immunology in the context of biodefense. Centers will be strongly 
encouraged to include trainees from non-Center laboratories in addition to 
Center laboratories. Education on the principles of human immunology may also 
be included, although formal courses will not be supported. Funds may not be 
used to support the salaries or stipends of the trainees. However, funds may 
be used for appropriate research supplies, and to compensate the effort of the 
facility personnel that provide the training. In addition, funds may be used 
to cover travel, 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. Finally, these funds may be used to 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. A plan for the process to be used for selection of 
trainees should be included in the application.

Research Projects and Pilot Projects must include research on NIAID Category 
A-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 the elderly, generation 
and maintenance of B and T cell memory, mechanisms of microbial immune 
evasion, and in vivo imaging of immune responses.

Inclusion of an external Scientific Advisory Committee may be proposed but is 
not required. If proposed, the applicant should explain the duties of such a 
Committee, and should include costs for meetings of Committee members with 
Center personnel. However, specific potential members of an external 
Scientific Advisory Committee should not be proposed in the application and 
should not be contacted prior to award.

MECHANISMS OF SUPPORT

This RFA will use the NIH Exploratory/Developmental Research Project Grant 
mechanism (R21) to fund activities to plan a U19 application, as well as the 
NIH Multi-Project Cooperative Agreement mechanism (U19).

The total requested project period for an application submitted in response to 
this RFA may not exceed one year for an R21.  

The 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." Essential elements of the multi-project cooperative agreement 
mechanism also include: (1) a minimum of three interrelated individual 
research projects organized around a central theme, (2) collaborative efforts 
and interaction among independent projects and their investigators to achieve 
a common goal, (3) a single Principal Investigator who will be scientifically 
and administratively responsible for the group effort, and who must commit an 
appropriate level of effort to the program, (4) a single applicant institution 
that will be legally and financially responsible for the use and disposition 
of the funds awarded, and (5) support provided, as necessary, for "Core" 
resources or facilities, each of which is expected to be utilized by at least 
two research projects in order to facilitate the research effort.  
Construction or renovation costs are not allowed under this RFA. 

At some institutions, the nucleus of a research group that could conduct a U19 
Centers program as described in this RFA may already exist, and such groups 
will be able to submit suitable applications for U19 awards directly. However, 
some groups may need an opportunity to establish themselves and formulate 
plans in preparation for submitting a U19 application. The Exploratory Grant 
(R21) mechanism may be used when the applicant wishes to request a one-year 
period of planning and preliminary investigation prior to preparing a U19 
application. The R21 application may request one-year funds for partial 
salaries of key investigators and technical staff, as well as for supplies and 
small equipment needs. The direct costs requested are not to exceed $200,000. 
Although there is no minimum effort requirement for the Principal Investigator 
of a R21 grant, an appropriate commitment must be made. A R21 grant is not 
required as a precursor to a U19 Center application. Furthermore, funding of a 
R21 grant does not obligate the NIAID to fund a subsequent U19 Center grant. 

The NIAID expects to re-announce this RFA next year for U19 grants only, in 
order to accept revised or new U19 applications for funding in fiscal year 
2004. However, re-announcement of the RFA will be dependent on the 
availability of sufficient funds. Therefore, this RFA may be a one-time 
solicitation.  Furthermore, 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.

As an applicant you 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.

FUNDS AVAILABLE  
 
The NIAID intends to commit approximately $12M in FY 2003 to fund 
approximately 3 U19 grants and 5-7 R21 grants in response to this RFA. An 
applicant may request a project period of up to five (5) years for the U19 and 
one year for an R21. Applicants may request up to $2,000,000 annual direct 
costs for U19 grants, and up to $200,000 annual direct costs for R21 grants.   
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 U19 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. 

Investigators whose applications direct costs are over $2,000,000 must contact 
program staff (listed below) and receive a written letter of approval stating 
NIAID will accept and review the application.  This is no way guarantees 
funding.

ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your 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  

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

A. Requirements for U19 Application

U19 applications in response to this RFA must be prepared using a multi-
project grant application format, as described at 
http://www.niaid.nih.gov/ncn/grants/multibron.htm   The U19 grant application 
should specify the administrative and organizational structure(s) that will be 
used to support the research. The synergies to be achieved through the 
establishment of multidisciplinary teams and novel collaborators should be 
fully described. The Principal Investigator is responsible for ensuring that 
the scientific goals are met, and for developing and managing a decision-
making structure and process that will allow resources to be allocated, and 
re-allocated if necessary, to meet these goals. The application should explain 
how the different components of the Center, including key personnel, will 
interact, and why they promote synergy. "Centers-without-walls" are welcome 
under this RFA, if proposed, the applicant should address how such 
interactions will be facilitated.
 
Milestones of Progress

Applications must describe 6- and 12-month milestones for each Center, to 
include timelines for establishment and operation of each component, and 
scientific milestones for the Research Resource Technical Development and 
Research Projects 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 
funding increment by NIAID will be based on a NIAID review of progress towards 
achieving the previously agreed upon milestones.

Pilot Projects

Innovative Pilot Projects will be an integral part of this program. Applicants 
should provide a short description of two proposed Pilot Projects as examples 
to be used during the review of the Center application. The description should 
be covered in three pages or less, and will serve to demonstrate the 
applicant"s capabilities to conceptualize and design novel studies. Award of 
the Cooperative Agreement does not imply that the particular proposed Pilot 
Projects will be implemented. A plan for the proposal, review, and 
implementation of Pilot Projects by Center investigators must be included in 
the application. Projects recommended by the Principal Investigator must 
receive NIAID approval before implementation.

Studies with Human Samples

Although clinical trials will not be supported under this RFA, human samples 
will be utilized in the research supported by this program. The NIAID 
Scientific Coordinator (see below) will facilitate compliance with NIH 
policies for monitoring activities commensurate with the degree of potential 
risk to human subjects. The NIAID policy including terms and conditions of 
award is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. As 
examples, the NIAID Scientific Coordinator might assist Centers with responses 
to questions on human subject protection, might facilitate interactions with 
FDA personnel, and might assist in the preparation of INDs.  

Statement of Institutional Commitment

The applicant institution should demonstrate its commitment to the stability 
and success of the Center by providing a statement of commitment that includes 
a plan addressing how the institutional commitment will be established and 
maintained, how the institution will maintain accountability for promoting 
scientific excellence, and how the Cooperative Centers for Translational 
Research on Human Immunology and Biodefense program will be given a high 
priority within the institution relative to other research efforts. Examples 
of institutional commitment include support for recruitment of scientific 
talent, provision of discretionary resources to the Principal Investigator, 
assignment of specialized research space, and cost sharing of resources or 
large equipment. A letter from the Dean confirming this commitment should be 
attached to the application. If a Center involves a consortium arrangement 
between two or more institutions, the parent institution that submits the 
application must receive a formal written agreement(s) from the other 
participant institutions that clearly delineates the institutional commitment 
of the participating organization(s).

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. 

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 
workshop.

B. Organizational Requirements for U19 Awards

Centers Steering Committee

Within 2 months of award, the NIAID will establish a Centers Steering 
Committee to serve as the governing body of the Cooperative Centers for 
Translational Research on Human Immunology and Biodefense. At a minimum, the 
Steering Committee will be composed of the Principal Investigators of each of 
the awarded U19 grants and the NIAID Scientific Coordinator. Each member of 
the Steering Committee will have one vote. The Steering Committee or the NIAID 
may identify and appoint other members, as appropriate. A Chairperson will be 
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 3 times during the first year, 
including a meeting in conjunction with the Annual Workshop, and semi-annually 
thereafter. 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 
CooperativeCenters for Translational Research on Human Immunology and 
Biodefense program. 

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 a subcontract 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.

GUIDANCE FOR R21 PLANNING GRANT APPLICATIONS

Applicants should follow a single-project application format describing the 
activities proposed for a one-year period that will prepare the Principal 
Investigator to submit a U19 application in response to a future RFA to 
support Cooperative Centers of Translational Research on Human Immunology and 
Biodefense (CCTRHIB). Appropriate activities may include, but are not limited 
to: the establishment or expansion of multi-investigator or interdisciplinary 
relationships, exploration of organizational concepts, building an 
administrative organization, development of the rationale and research design 
for the subsequent Center, development of assays or technologies for the 
Research Resource Technical Development component, and the collection of 
preliminary data for the Research Projects component. These activities should 
be described in the context of the anticipated U19 Center grant application 
goals and requirements. Funds may be used for salary support, as appropriate, 
training in scientific procedures, travel to establish collaborations, or 
laboratory supplies and small equipment. The standard PHS 398 form should be 
used and sections A-D must not exceed 25 pages. A modular budget should be 
proposed (http://grants.nih.gov/grants/funding/modular/modular.htm).

In order to indicate that the application is for an R21 award, please use the 
following Application Title: "R21 Planning Grant for the CCTRHIB Program". 
Also, please state in the Abstract that the application is for an R21 Planning 
Grant for the CCTRHIB Program. In the Research Design and Methods section of 
the application, please describe your plans for assembling appropriate Center 
member candidates, and plans to obtain any needed preliminary data or research 
resources, to support a future U19 application. Plans to develop each of the 
essential components of a U19 application should be included: the Research 
Resource Technical Development, Research Projects, Core Facilities, Pilot 
Projects, and Education components. For each component, describe the 
particular strengths to be incorporated into a potential Center and the 
advantages of such a Center to the CCTRHIB program as a whole. Describe 
available infrastructure and how you will build on these resources. Provide 
sufficient information to allow reviewers to realistically evaluate the 
probability that a strong U19 application can be developed within the one-year 
time frame.

COOPERATIVE AGREEMENT (U19) 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 multi-
project cooperative agreement (U19). The 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 below. 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 Human Subjects Protection. 

When human samples are a component of the research proposed, NIAID policy 
requires that studies be monitored commensurate with the degree of potential 
risk to human subjects.  Terms and Conditions of Award will be included with 
awards. The NIAID 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

Each Center must establish 6- and 12-month milestones and timelines for 
establishment and operation of each component, and scientific milestones for 
the Research Resource Technical Development and Research Projects 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 funding increment by NIAID 
will be based on a NIAID review of progress towards achieving the previously 
agreed upon milestones.

Pilot Projects

Award of the Cooperative Agreement does not imply that the particular proposed 
Pilot Projects will be implemented. A plan for the proposal, review, and 
implementation of Pilot Projects by Center investigators must be included in 
the application. Projects recommended by the Principal Investigator must 
receive NIAID approval before implementation. The research proposed must focus 
on NIAID Category A-C agents. This component is intended to provide additional 
flexibility to the program and will support studies of limited duration (six 
months to two years) and of limited budget ($50-100,000 direct costs per pilot 
project per year). These funds may not be used for equipment purchase or 
renovations.

Studies with Human Samples

Although clinical trials will not be supported under this RFA, human samples 
will be utilized in the research supported by this program. The NIAID 
Scientific Coordinator (see below) will facilitate compliance with NIH 
policies for monitoring activities commensurate with the degree of potential 
risk to human subjects. The NIAID policy including terms and conditions of 
award is available at: http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. As 
examples, the NIAID Scientific Coordinator might assist Centers with responses 
to questions on human subject protection, might facilitate interactions with 
FDA personnel, and might assist in the preparation of INDs. The NIH brochure 
entitled "Research on Human Specimens: Are You Conducting Research Using Human 
Subjects?" may also be of use to applicants 
(http://www-cdp.ims.nci.nih.gov/policy.html).

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. 

Annual Workshop

Principal Investigators must 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 workshop.

Centers Steering Committee

Within 2 months of award, the NIAID will establish a Centers Steering 
Committee to serve as the governing body of the Cooperative Centers for 
Translational Research on Human Immunology and Biodefense. At a minimum, the 
Steering Committee will be composed of the Principal Investigators of each of 
the awarded U19 grants and the NIAID Scientific Coordinator. Each member of 
the Steering Committee will have one vote. The Steering Committee or the NIAID 
may identify and appoint other members, as appropriate. A Chairperson will be 
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 3 times during the first year, 
including a meeting in conjunction with the Annual Workshop, and semi-annually 
thereafter. Each Steering Committee member must 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 program. 

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 a subcontract 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.

3. NIAID Staff Responsibilities
     
A program officer from the Basic Immunology Branch, Division of Allergy, 
Immunology, and Transplantation, NIAID, will serve as NIAID"s Scientific 
Coordinator and will provide NIAID staff assistance. 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.

The NIAID Scientific Coordinator will attend all Centers Steering Committee 
meetings and participate with one vote in this and in other Committee and 
Subcommittee activities. The NIAID Scientific Coordinator will also provide 
expertise in technology and resource development, availability, and 
application, development, design, and implementation of studies with human 
samples, policies and procedures for the protection of human subjects, and 
will serve as a liaison to other NIH-sponsored programs to facilitate 
collaboration and coordination.

In addition, the NIAID Program Director, a program officer from the Basic 
Immunology Branch, Division of Allergy, Immunology and Transplantation, NIAID, 
will be responsible for normal programmatic monitoring and stewardship for the 
award.

The NIAID Program Director will approve changes in proposed milestones, 
approve proposed Pilot Projects, and approve redirection of Research Projects 
or Research Resource Technical Development components.

The NIAID Program Director will 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.

The NIAID Grants Management Specialist, in consultation with the NIAID Program 
Director, must approve in writing any 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.

The NIAID Program Director may also serve as the NIAID Scientific Coordinator.

4.  Collaborative Responsibilities

Collaborative responsibilities are as detailed above in the section on 
Cooperative Agreement (U19) Terms and Conditions of Award under "Awardee 
Rights and Responsibilities" for the Centers Steering Committee, Milestones of 
Progress, Pilot Projects, Cooperative Resources, and Intellectual Property 
sections.

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 or by the individual awardee in the event 
of an individual disagreement, a second member selected by the NIAID, and the 
third member with expertise in the relevant area and selected by the two prior 
members will be formed to review any scientific or programmatic issue that is 
significantly restricting progress.  While the decisions of the Arbitration 
Panel are binding, these special arbitration procedures will in no way affect 
the awardee"s right to appeal an adverse action in accordance with PHS 
regulations at 42 CFR Part 50, subpart D, and HHS regulations at 45 CFR Part 
16.

WHERE TO SEND INQUIRIES

We strongly 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 your questions about scientific/research issues to:

Helen Quill, Ph.D.  
Division of Allergy, Immunology, and Transplantation
National Institute of Allergy and Infectious Diseases  
Room 5140, MSC-7640
6700-B Rockledge Drive
Bethesda, MD  20892-7640
Telephone:  (301) 496-7551
FAX:        (301) 402-2571
E-Mail:     hq1t@nih.gov
  
o Direct your questions about peer review issues, address the letter of 
intent, mail two copies of the application and all five sets of appendices to:
  
Ed Schroder, Ph.D.  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 2151, MSC-7616
6700-B Rockledge Drive  
Bethesda, MD  20892-7616
Telephone:  (301) 435-8537
FAX:        (301) 402-2638
E-Mail:     es170m@nih.gov

o Direct your 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
E-Mail:    ad22x@nih.gov
 
LETTER OF INTENT

Prospective applicants for U19 or R21 grants 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:

Ed Schroder, Ph.D.  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 2151, MSC-7616
6700-B Rockledge Drive  
Bethesda, MD  20892-7616 (20817 for express mail)
Telephone:  (301) 435-8537
FAX:        (301) 402-2638
E-Mail:     es170m@nih.gov

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 for U19 and R21 grants must be prepared using the PHS 398 
research grant application instructions and forms (rev. 5/2001). The PHS 398 
is available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an 
interactive format.  For further assistance contact GrantsInfo, Telephone 
(301) 435-0714, Email: GrantsInfo@nih.gov.

USING THE RFA LABEL: For both U19 and R21 applications, 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:

Ed Schroder, Ph.D.  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 2151, MSC-7616
6700-B Rockledge Drive  
Bethesda, MD  20892-7616 (20817 for express mail)
Telephone:  (301) 435-8537
FAX:        (301) 402-2638
E-Mail:     es170m@nih.gov

Applications that are not received as a single package on the receipt date 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 scientific/research program contact 
under INQUIRIES).

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.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must include 
an Introduction addressing the previous critique.

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.

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 Institute of 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.

SPECIFIC REVIEW CRITERIA for U19 applications: In addition to the above 
criteria, your application will also be reviewed with respect to the 
following:

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 program.
(b) Sufficient focus on human immunology and assay, 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.
(g) Adequacy and feasibility of applicant"s described milestones of progress 
that will be used to assess productivity and accountability.

2. Research Resource Technical Development Component

Adequacy of the applicant"s plans to develop, validate, and disseminate new 
assays, reagents, and technologies for the timely and optimal study of human 
immunology for biodefense.

3. Research Project Component

(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 to 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.

4. Core Facilities Component

(a) 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.
(b) Feasibility and clarity of plans for prioritizing the use of facilities by 
Center members. 
(c) Use of core facilities to conserve resources for common tasks such as MHC 
typing, microarray gene or protein expression assays, or MHC-peptide tetramer 
generation.

5. Pilot Project Component

(a) Scientific strengths of the two proposed examples of pilot projects in the 
context of 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 further develop the projects begun as pilots.

6. Education Component

(a) Adequacy of the applicant"s plans to select and train laboratory staff, 
postdoctoral fellows, faculty members, and scientists who are not Center 
members in the use of assays, reagents, and technologies to study human 
immunology in the context of biodefense. 
(b) Appropriateness of plans to support short-term training for scientists 
from non-Center institutions, if proposed. 
(c) Appropriateness of plans to support seminar series/symposia, if proposed.

SPECIAL REVIEW CRITERIA for R21 applications: your application will be 
reviewed to determine the probability that a strong U19 application can be 
developed, within the one-year period of award, that satisfies the criteria 
listed above for a U19 grant.

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or 
the environment, to the extent they may be adversely affected by the project 
proposed in the application.

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

o 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 20, 2002
Application Receipt Date:               January 22, 2003
Scientific Peer Review Date:            June 2003 
Advisory Council Review:                July 2003
Earliest Anticipated Start Date:        September 2003      

AWARD CRITERIA

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

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.

REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components 
involving Phase I and II clinical trials must include provisions for 
assessment of patient eligibility and status, rigorous data management, 
quality assurance, and auditing procedures.  In addition, it is NIH policy 
that all clinical trials require data and safety monitoring, with the method 
and degree of monitoring being commensurate with the risks (NIH Policy for 
Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 
  
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of the 
research. This policy results from the NIH Revitalization Act of 1993 (Section 
492B of Public Law 103-43).

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

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

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

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

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

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

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

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

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

AUTHORITY AND REGULATIONS

This program is described in the Catalogue of Federal Domestic Assistance 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.

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

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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