COOPERATIVE STUDY GROUP FOR AUTOIMMUNE DISEASE PREVENTION

Release Date:  September 7, 2000

RFA:  AI-00-016 (This RFA has been reissued, see RFA-AI-05-026)

National Institute of Allergy and Infectious Diseases
 (http://www.niaid.nih.gov/)
National Institute of Diabetes and Digestive and Kidney Diseases
 (http://www.niddk.nih.gov/)
National Institute of Child Health and Human Development
 (http://www.nichd.nih.gov/)
National Institute of Dental and Craniofacial Research
 (http://www.nidcr.nih.gov/) 
National Institute of Arthritis and Musculoskeletal and Skin Diseases
 (http://www.nih.gov/niams)
Office of Research on Women’s Health, National Institutes of Health
 (http://www4.od.nih.gov/orwh/)
The Juvenile Diabetes Foundation International
 (http://www.jdf.org/)

Letter of Intent Receipt Date:  December 15, 2000
Application Receipt Date:       February 26, 2001

APPLICATIONS IN RESPONSE TO THIS REQUEST FOR APPLICATIONS (RFA) MUST BE 
PREPARED USING SPECIFIC INSTRUCTIONS IN AN NIAID BROCHURE ENTITLED 
"INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT AWARDS” available at: 
http://www.niaid.nih.gov/ncn/grants/multibron.htm.

PURPOSE

The National Institute of Allergy and Infectious Diseases (NIAID), the 
National Institute of Diabetes and Digestive and Kidney Diseases 
(NIDDK), the National Institute of Child Health and Human Development 
(NICHD), the National Institute of Arthritis and Musculoskeletal and 
Skin Diseases (NIAMS), the National Institute of Dental and Craniofacial 
Research (NIDCR), the Office of Research on Women’s Health (ORWH), 
National Institutes of Health (NIH), and the Juvenile Diabetes 
Foundation International (JDFI) invite applications from single 
institutions or consortia of institutions to participate in the 
Cooperative Study Group for Autoimmune Disease Prevention.  The purpose 
of this program is to support a closely interactive and collaborative 
network of investigators in a unique study group to focus on autoimmune 
disease prevention.  This group will: 1) advance the understanding of 
immune homeostasis in autoimmune diseased states as well as non-diseased 
states, including the pediatric immune response, and 2) build the 
knowledge base needed to develop interventions for the prevention of 
human autoimmune diseases, with special emphasis on type 1 diabetes.  
The Cooperative Study Group will engage in collaborative and individual 
projects focused on understanding the immune mechanisms that underlie 
autoimmunity and autoimmune diseases, mechanisms and consequences of 
manipulation of the immune response in autoimmunity, and application of 
this information to the prevention of autoimmune disease in humans.  For 
the purpose of this RFA, “prevention of autoimmune disease” is defined 
as halting the development of an autoimmune disease prior to clinical 
onset by mechanisms other than global immunosuppression.  

Each application must include a minimum of three projects; at least one 
project must focus directly on type 1 diabetes; applications that 
include projects on other autoimmune diseases or projects related to 
more than one disease are particularly encouraged, however, applications 
may focus entirely on diabetes.  Animal studies are allowed under this 
RFA, but the applicant must document the relevance of such models to 
development of preventive strategies for humans.  Applications from 
consortia of institutions are strongly encouraged to ensure that the 
scope of scientific expertise necessary to meet the requirements of this 
RFA is available.  All applicants must comply with the requirements 
outlined in the section below entitled "SPECIAL REQUIREMENTS."

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 Request for 
Applications (RFA), “COOPERATIVE STUDY GROUP FOR AUTOIMMUNE DISEASE 
PREVENTION,” is related to the focus area of diabetes and chronic 
disabling diseases. Potential applicants may obtain a copy of "Healthy 
People 2010" at http://www.health.gov/healthypeople.

ELIGIBILITY REQUIREMENTS

Research grant applications may be submitted by domestic for-profit and 
non-profit organizations, public and private institutions, such as 
universities, colleges, hospitals, laboratories, units of State and 
local governments, and eligible agencies of the Federal government.  
Foreign institutions are not eligible to apply, but applications from 
United States institutions may include foreign components.  
Racial/ethnic minority individuals, women, and persons with disabilities 
are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

The administrative and funding mechanism to be used to undertake this 
program will be the Multiproject Cooperative Agreement (U19), an 
"assistance" mechanism, rather than an "acquisition" mechanism.  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 NIH is 
not to assume direction, prime responsibility, or a dominant role in the 
activity.  Essential elements of the multiproject 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; (4) a single applicant institution that will be 
legally and financially responsible for the use and disposition of 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.  Details 
of the responsibilities, relationships and governance of a study funded 
under a cooperative agreement are discussed later in this document under 
the section "Terms and Conditions of Award."

Applicants must propose a 5-year plan in order to maintain the integrity 
of the Cooperative Study Group.

FUNDS AVAILABLE

The estimated total funds, direct and facilities & administrative (F&A), 
available for the first year of support for this RFA will be $7 million.  
In fiscal year 2001, the sponsoring organizations plan to make 5 awards 
related to this RFA.  Additional funds, approximately $2.5 million per 
year, will be made available to successful applicants.  This level of 
support is dependent on the receipt of a sufficient number of 
applications of high scientific merit. 

First-year budget requests may not exceed $900,000 total costs.  
Additional funds, approximately $2.5 million per year, will be available 
to successful applicants to support Innovative Projects, Clinical 
Studies, and/or Cooperative Resources based on Steering Committee 
recommendations (see SPECIAL REQUIREMENTS, below).

The usual PHS policies governing grants administration and management 
will apply.  Although this program is provided for in the financial 
plans of the NIH, awards pursuant to this RFA are contingent upon the 
availability of funds for this purpose.  Funding beyond the first and 
subsequent years of the grant will be contingent upon satisfactory 
progress during the preceding years and availability of funds.

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

RESEARCH OBJECTIVES  

Background  

Autoimmune diseases, which disproportionately afflict women, are 
debilitating, chronic illnesses that affect multiple organ systems.  
Type 1 diabetes afflicts over 600,000 persons in the United States with 
peak onset in childhood.  Although insulin treatment is available, long-
term complications include kidney failure, blindness, amputations, and 
accelerated cardiovascular disease.  Sjögren’s syndrome, which affects 
predominantly middle-aged women, results in diminished lacrimal and 
salivary gland function.  Patients may suffer dysphagia, atrophic 
gastritis, esophageal mucosal atrophy, constipation, and sub clinical 
pancreatic insufficiency.  About 30% of patients with rheumatoid 
arthritis, systemic lupus erythematosus and systemic sclerosis suffer 
secondary Sjögren’s syndrome, while 2 to 5 % of people aged 60 and above 
have primary Sjögren’s syndrome. Multiple sclerosis afflicts over 
350,000 persons in the United States; women are affected twice as 
frequently as men. Although the course of the disease is unpredictable, 
the central and peripheral nerve impairment can lead to blindness, 
weakness, loss of bowel and bladder control, and confinement to a 
wheelchair.  Rheumatoid arthritis, which also affects primarily women, 
usually at an older age, causes chronic pain, crippling deformity, and 
loss of independence.  This disease afflicts over 2% of the U.S. 
population. The 1999 Institute of Medicine report, “Vaccines for the 
21st Century: A Tool for Decision Making,” concluded that the 
development of vaccines to treat or prevent type 1 diabetes, multiple 
sclerosis, and rheumatoid arthritis would bring exceptionally high 
economic and health benefits.  Preventive vaccines for other autoimmune 
diseases, including the less common but devastating pediatric autoimmune 
diseases such as juvenile rheumatoid arthritis and Kawasaki's disease 
would also enhance the public health. The Congressionally established 
Diabetes Research Working Group’s 1999 report entitled “Conquering 
Diabetes: A Strategic Plan for the 21st Century,” 
[http://mantis.cit.nih.gov/temp/diabetes/cd.pdf] highlighted basic and 
clinical research into the pathogenesis and prevention of type 1 
diabetes as an extraordinary opportunity to significantly improve the 
future health of the nation.  

Recent evidence suggests that autoimmunity or the autoimmune process may 
precede the development of clinical disease by years in type 1 diabetes 
and other autoimmune diseases.  Although loss of beta cell function with 
development of hyperglycemia defines the diagnosis of type 1 diabetes, 
evidence of autoimmunity manifested by multiple autoantibodies to islet 
antigens may be apparent years earlier.  In addition, evidence of 
autoimmunity in healthy individuals (e.g., multiple autoantibodies in 
family members of patients with type 1 diabetes who do not develop 
disease, e.g., non-progressors) suggests that mechanisms to control 
autoimmunity may be operative in immune homeostasis in healthy 
individuals.  Similarly, synovial cell activation and inflammation in 
rheumatoid arthritis may precede the onset of multiarticular pain and 
cartilage destruction, the hallmarks of this disease. Increased 
understanding of the processes for containment of autoimmunity found in 
healthy individuals, novel strategies to control or prevent autoimmunity 
prior to the onset of clinical disease, and safe and rational 
application of these strategies to humans are needed.  

Since the onset of the autoimmune process may precede by years the 
diagnosis, a further understanding of neonatal and pediatric immune 
homeostasis is needed, both in healthy and autoimmune prone individuals.  
Intervention at the earliest possible stage may be optimal for 
preventing these diseases.  

Type 1 diabetes and other autoimmune diseases have been prevented in 
animal models using a variety of agents, hypothesized to be acting as 
toleragens or immunomodulators.  However, our understanding of the 
mechanism and consequences of these approaches in animals is incomplete.  
Likewise, information on immune homeostasis of autoimmune responses in 
humans is lacking.  Nevertheless, the ability to selectively prevent 
development of or control the activity of
autoreactive cells prior to onset of clinical disease without impairing 
protective immune responses appears feasible. 

Research Objectives and Scope  

This RFA will support a cooperative study group focused on research for 
the prevention of human autoimmune disease.  For the purpose of this 
RFA, “prevention of autoimmune disease” is defined as halting the 
development of an autoimmune disease prior to clinical onset by 
mechanisms other than global immunosuppression.  The ultimate goal of 
this research is to develop the knowledge base necessary to design 
preventive interventions that could be administered efficiently and 
safely to at-risk individuals or to the general population, most likely 
infants or children.  While the interventions may also be beneficial in 
established disease, the focus of this RFA is on prevention rather than 
therapy.  Clinical studies are strongly encouraged wherever possible.  
Animal studies proposed under this RFA must document the relevance of 
the model to the development of preventive strategies for human 
autoimmune diseases.  Each application must include at least one project 
focused directly on type 1 diabetes; applications that include projects 
on other autoimmune diseases or projects related to more than one 
autoimmune disease are particularly encouraged, however, applications 
may focus entirely on diabetes. 

The Cooperative Study Group will be comprised of a consortium of 
investigators who, in collaboration with the NIH, will develop and 
implement a Study Group Plan for autoimmune disease prevention.  The 
Study Group Plan will guide the allocation of additional resources to 
support Innovative Pilot Projects, Clinical Studies, and Cooperative 
Resources.  The Study Group Plan will articulate the goals, specify the 
approaches, and define milestones for the activities of the Study Group 
[see “Study Group Plan” in SPECIAL REQUIREMENTS, below].    
  
Research projects must contribute knowledge critical to achieving both 
of the following goals:

1. Advance the understanding of immune homeostasis in autoimmune 
diseased states as well as non-diseased states.  This area includes 
studies of the immune control of autoantigen-specific T or B cells by 
mechanisms including peripheral deletion, anergy, or control by other 
protective cells, as well as research on the dysregulation of immune 
homeostatic mechanisms in autoimmune diseases.  Research topics include, 
but are not limited to:

o   Delineation of the phenotype and function of regulatory and effector 
T cell populations in target tissues and associated lymphoid organs; 
o   Development of the immune response to self in healthy and autoimmune 
prone infants and children;
o   Definition of the role of the innate immune system in the 
maintenance and breakdown of immune homeostasis; 
o   Determination of the function of antigen processing and antigen 
presenting cell activity in the development and maintenance of self 
tolerance; and
o   Definition of the role of genetic susceptibility and environmental 
influences on loss of homeostasis in autoimmune disease.

2. Design and develop interventions to prevent human autoimmune 
diseases, with special emphasis on type 1 diabetes.   This includes the 
application of new information on the autoimmune disease process to 
facilitate the design of novel approaches and the improvement of 
promising strategies for autoimmune disease prevention.  Research may 
include studies of the feasibility and mechanisms of preventive 
approaches in humans.  Research topics include, but are not limited to:

o   Practical approaches to target agents to desired cellular 
populations and to evaluate their effectiveness in vivo;
o   Utilization of new adjuvants and delivery approaches to boost 
regulatory cells; 
o   Analyses of the consequences of intervention approaches on 
protective immunity and autoimmune responses; 
o   Practical means to identify populations most likely to benefit from 
specific interventions;
o   Development and validation of bio-markers of disease risk, stage, 
activity, and immune responses; and
o   Development and application of clinically relevant animal models to 
facilitate the translation of preventive approaches from animals to 
humans.  

Studies of vaccines or therapeutics directed against infectious agents 
may be included if there is strong evidence for a causal relationship 
between the infectious agent and the occurrence of an autoimmune disease 
in the infected population. 

Applicants are strongly encouraged to include clinical studies as an 
integral part of the required three projects.  Such studies should be 
designed to investigate the mechanisms of autoimmune disease, develop or 
validate biomarkers of disease risk, and/or delineate the mechanisms of 
preventive strategies.  Examples of clinical studies that may be 
proposed include: immunological studies of patient samples obtained from 
ongoing or completed clinical trials, and comparative analyses of immune 
responses in diseased and non-diseased individuals.  This RFA will 
support only very limited phase 1 trials of the safety, toxicity or 
efficacy of candidate prevention approaches, which result from the 
research within this program.  Clinical trials may not be submitted in 
the initial application and must be submitted and approved by the 
Steering Committee (see below) as clinical studies.  If agents show 
promise, phase II and phase III clinical trials can be funded through 
collaborative arrangements with other programs, including the 
Autoimmunity Centers of Excellence, the Immune Tolerance Network, or the 
Diabetes Prevention Trial-Type 1/Diabetes TrialNet.  

Specifically excluded are studies of globally immunosuppressive 
therapies.

SPECIAL REQUIREMENTS

A.  Study Organization

1. Steering Committee

A Steering Committee will be established to serve as the main governing 
body of the Cooperative Study Group for Autoimmune Disease Prevention 
(hereinafter referred to as the Study Group).  At a minimum, the 
Steering Committee will be composed of the principal investigators of 
each of the awarded grants, the Chairperson of the Adjunct Clinical 
Studies Subcommittee (see item 2 below), and an NIH representative.  
Each member of the Steering Committee will have one vote.  The Steering 
Committee or the NIH 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 three times during the first year, and semi-annually 
thereafter.  Each Steering Committee member will be expected to 
participate in all meetings and other Steering Committee activities, 
e.g., conference calls, special subcommittees, etc., as may be necessary 
to accomplish the work of the Study Group.  

The Steering Committee will be responsible for developing the Study 
Group Plan (see item 3 below), which will outline the goals, approaches, 
and milestones for the activities of the Study Group.  In addition, the 
Steering Committee will be responsible for ensuring that the activities 
of all Study Group investigators are coordinated, collaborative when 
appropriate, directed toward the goal of developing prevention 
strategies for human autoimmune diseases, and productive.  The Steering 
Committee will review the progress of all projects on an annual basis 
and make recommendations for: continuation or redirection of ongoing 
projects; incorporation of additional expertise needed for accomplishing 
goals; and future directions.  

The Steering Committee will have access to additional NIH funds to 
support: 1) Innovative Pilot Projects; 2) Clinical Studies; and 3) 
Cooperative Resources in order to accomplish the goals of the Study 
Group.  The Steering Committee’s responsibility to conduct and oversee 
Innovative Pilot Projects, Clinical Studies, and Cooperative Resources 
is intended to encourage cooperative, collaborative, and directed 
efforts of the participating members.  

2. Adjunct Clinical Studies Subcommittee

The Steering Committee shall appoint an Adjunct Clinical Studies 
Subcommittee to have primary responsibility for assisting the Study 
Group investigators in accessing, developing, designing, and 
implementing clinical studies to investigate the mechanisms of immune 
homeostasis in autoimmune diseased states as well as non-diseased states 
and the mechanisms of preventive strategies in humans.  The Clinical 
Studies Subcommittee will be responsible for reviewing and making 
recommendations to the Steering Committee with regard to the 
implementation of clinical studies proposed by Study Group Members, and 
for coordinating these studies to facilitate collaboration and efficient 
use of clinical samples.  Clinical studies approved in the initial 
application will not require Steering Committee approval but will 
undergo progress reviews.  The members of the Clinical Studies 
Subcommittee shall include one NIH representative as well as 
representatives selected by the Principal Investigators, with each site 
appointing one member.  Each member will have one vote.  The Chair of 
the Adjunct Clinical Studies Subcommittee will be elected from among the 
non-federal members and shall serve as a voting member of the Steering 
Committee.  The Subcommittee will meet in conjunction with Steering 
Committee meetings.  Subcommittee members will be expected to 
participate in all Subcommittee meetings and other Subcommittee 
activities.  

3. Study Group Plan

The Steering Committee shall develop the Study Group Plan, which will 
articulate the goals, specify the approaches, and define milestones for 
the activities of the Study Group in understanding immune homeostasis in 
diseased and non-diseased states, the consequences of manipulation of 
immune responses, and the development of strategies for the prevention 
of autoimmune diseases. The Plan shall include procedures and criteria 
for reviewing and for assessing progress on an annual basis and in 
developing recommendations for future directions.  The Steering 
Committee will submit a draft Study Group Plan to the NIH within 3 
months of award, and the final plan within 6 months of award.  

4. Innovative Pilot Projects

Innovative Pilot Projects will be an integral part of this program.  
Proposals from Study Group members for innovative, exploratory, high-
risk/high-yield, novel, and/or pilot research to advance the goals of 
the Study Group will be supported with resources available to the 
Steering Committee.  The Steering Committee will develop procedures for 
the submission of proposed pilot projects, and criteria for the 
evaluation and selection of pilot projects to be implemented by the 
Study Group.  The Steering Committee may approve more than one 
Innovative Pilot Project at any single Study Group site.  Innovative 
Pilot Projects may be funded for a period of 6 months up to a maximum of 
2 years duration with budgets ranging from $50,000 to approximately 
$150,000 total costs per year as recommended by the Steering Committee. 

5. Clinical Studies

It is anticipated that many opportunities for new clinical studies will 
arise within the Study Group as a result of new collaborations, expanded 
access to patients and clinical samples, and development of new 
hypotheses relevant for human autoimmune disease.  To capitalize on 
these anticipated opportunities, additional clinical studies will be 
supported with resources available to the Steering Committee.  Clinical 
studies must address the goals of the Study Group, including 
investigation of the mechanisms of autoimmune disease, development 
and/or validation of biomarkers of disease risk, and/or delineation of 
the mechanisms underlying preventive strategies.  This program will 
support only very limited phase 1 trials of the safety, toxicity or 
efficacy of candidate prevention approaches, which result from the 
research within this program.  Clinical trials may not be submitted in 
the initial application and must be submitted and approved by the 
Steering Committee as clinical studies.  If agents show promise, phase 
II and phase III clinical trials can be funded through collaborative 
arrangements with other programs, including the Autoimmunity Centers of 
Excellence, the Immune Tolerance Network, or the Diabetes Prevention 
Trial-Type 1/Diabetes TrialNet.  The Adjunct Clinical Studies 
Subcommittee will be responsible for reviewing and evaluating proposals 
for additional clinical studies and making recommendations to the 
Steering Committee for proposals to be implemented by the Study Group.  
The Subcommittee will establish procedures and criteria for the 
submission and evaluation of proposed clinical studies, and will assist 
in study development, design, implementation, coordination, and 
analysis.  All clinical trials will be reviewed and monitored by the 
appropriate NIAID Data and Safety Monitoring Board.    

6. Cooperative Resources

The Steering Committee will establish and support Cooperative Resources 
that provide central assistance and technical expertise for the projects 
undertaken by the Study Group investigators.  These Cooperative 
Resources will provide reagents and services, as needed, to all members 
of the Study Group.  The Steering Committee will determine procedures 
for the designation of Cooperative Resources, and will determine the 
scope of work and level of support based on Study Group requirements.  
Non-administrative cores proposed by individual members of the Study 
Group in the application may be expanded by the Steering Committee to 
become Cooperative Resources (with addition of funds available to 
Steering Committee).  See “Additional Requirements for Application” 
below for special application instructions for non-administrative cores.  
Cooperative Resources may be housed at Study Group member sites or 
supported through a subcontract to other facilities.  

7. Coordination with other NIH-sponsored programs

The Cooperative Study Group will coordinate their efforts with other 
NIH-funded programs.  Information obtained by the Cooperative Study 
Group will facilitate the design of clinical trials of preventive 
agents.  Equally, ongoing or planned clinical trials offer a unique 
source of patient samples for human immune response studies by Study 
Group investigators.  NIH-sponsored programs that support clinical 
trials in autoimmune diseases include, but are not limited to, the 
Immune Tolerance Network, the Autoimmunity Centers of Excellence, and 
the Diabetes Prevention Trial-Type 1/Diabetes TrialNet.

8. Budgets

First-year budget requests may not exceed $900,000 total costs.  
Additional funds in the amount of approximately $2.5 million per year 
will be available to successful applicants to support initiation or 
expansion of Innovative Pilot Projects, Clinical Studies, and/or 
Cooperative Resources based on Steering Committee recommendations.
 
9. Meetings

Applicants must include costs for participation of the Principal 
Investigator in all Steering Committee meetings and for an additional 
appointee for the Adjunct Clinical Studies Subcommittee.  There will be 
three Steering Committee meetings in the first year, and semi-annual 
meetings each year thereafter. For budgetary purposes, applicants should 
assume meetings will be 1½ days in duration and held in Bethesda, MD.  
One of the semi-annual meetings will include presentation of scientific 
accomplishments for all projects by the Principal Investigators. 

B.  Minimum Requirements for Application

1.  A broad range of scientific and technical expertise is required to 
carry out the objectives of this RFA, including extensive experience in: 
the study of basic animal and human immunology; mechanisms of 
autoimmunity and specific autoimmune diseases, including type 1 
diabetes; genetics; molecular and cellular biology, particularly as 
applied to the identification and evaluation of biomarkers and assay 
development and validation; and human research involving clinical 
samples.  Applications must include scientific expertise in these areas 
under the direction of a senior scientist, serving as the Principal 
Investigator, with the responsibility for the scientific, technical, and 
administrative coordination and management of the applicant group.  The 
Principal Investigator is advised to devote at least 20% effort to this 
program in the first year.

2.  A minimum of three research projects must be proposed. At least one 
project must specifically address type 1 diabetes. Applications that 
include projects on other autoimmune diseases or projects related to 
more than one disease are particularly encouraged, however, applications 
may focus entirely on diabetes.  

3.  Support may be requested 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.  The costs for these cores must 
be included within the budget request limit of $900,000 first year total 
costs.  Cores may be funded as proposed to support at least two of the 
research projects, or they may be modified by the Steering Committee in 
order to most effectively serve the needs of the Study Group members.  
Such modifications may include consolidating core resources with 
centralized cooperative resources, or expanding core resources and 
facilities to serve as Cooperative Resources for multiple members of the 
Group.  Cooperative Resources, which support the whole Study Group and 
are approved by the Steering Committee, will receive additional funds.  
Applicants who wish to serve as Cooperative Resources must: describe the 
capabilities of the investigators and the institutions to expand the 
proposed function/activity to fulfill the needs of the group; present an 
overall plan describing how an increase of up to five-fold would be 
implemented and managed; and develop and submit a separate budget 
detailing the projected additional personnel, supplies, and facility 
costs involved in such an expansion as well as the estimated cost per 
unit of service.  The plan for expansion of the proposed cores to serve 
as Cooperative Resources will be reviewed for technical merit but will 
not affect the overall score of the application. 

4.  Innovative Pilot Projects: Application must include two proposed 
pilot projects to demonstrate applicant’s capabilities to conceptualize 
and design novel studies.  These proposed pilot projects will be peer 
reviewed and their technical merit reflected in determining the overall 
score of the application.  Award of the Cooperative Agreement does not 
imply that any of the proposed pilot projects will be implemented.  The 
pilot projects to be conducted by the Study Group will be selected by 
the Steering Committee and, therefore, the actual pilot projects may not 
reflect any single proposed project submitted in response to this RFA.  
Both proposed pilot projects should be described in 2-5 pages in the 
application immediately following the Overview section.  Proposed costs 
for these projects must be included, but detailed categorical budgets 
should not be included.  Costs for innovative pilot projects should not 
be included in the calculation of total first year program costs. 

5.  The application must include a written commitment to accept the 
participation and assistance of NIH staff in accordance with the 
guidelines outlined under "Terms and Conditions of Award: NIH Staff 
Responsibilities." The application must also include a written 
commitment to the cooperative organization, including agreement to 
intellectual property rights certification as indicated under “Terms and 
Conditions of Award,” (see below) and willingness to serve and commit 
appropriate effort to the work of the Steering Committee.  In addition, 
the applicants must agree to adhere to the decisions reached by that 
Steering Committee, including selection of core facilities, Cooperative 
Resources, Innovative Pilot Projects, Clinical Studies, and annual 
review of all projects funded under this program.
  
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. 

Cooperative agreements are subject to the administrative requirements 
outlined in OMB circulars A-102 and A-110.  All pertinent HHS, PHS, and 
NIH grant regulations, policies and procedures, with particular emphasis 
on PHS regulations at 42 CFR Part 52 and HHS regulations at 45 CFR Parts 
74 and 92, are applicable. 

The administrative and funding instrument used for this program is the 
multiproject cooperative agreement (U19), an "assistance" mechanism 
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 NIH Scientific Coordinators.

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.  Terms and Conditions of Award 
will be included with awards.  NIAID policy was announced in the NIH 
Guide on February 24, 2000 and is available at: 
http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.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.

Steering Committee

A Steering Committee will be established to serve as the main governing 
body of the Cooperative Study Group for Autoimmune Disease Prevention 
(hereinafter referred to as the Study Group).  At a minimum, the 
Steering Committee will be composed of the principal investigators of 
each of the awarded grants, the Chairperson of the Adjunct Clinical 
Studies Subcommittee (see below), and an NIH representative.  Each 
member of the Steering Committee will have one vote.  The Steering 
Committee or the NIH 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 three times during the first year, and semi-annually 
thereafter.  Each Steering Committee member will be expected to 
participate in all meetings and other Steering Committee activities, 
e.g., conference calls, special subcommittees, etc., as may be necessary 
to accomplish the work of the Study Group.  

The Steering Committee will be responsible for developing the Study 
Group Plan (see below), which will outline the goals, approaches, and 
milestones for the activities of the Study Group.  In addition, the 
Steering Committee will be responsible for ensuring that the activities 
of all Study Group investigators are coordinated, collaborative when 
appropriate, directed toward the goal of developing prevention 
strategies for human autoimmune diseases, and productive.  The Steering 
Committee will review the progress of all projects on an annual basis 
and make recommendations for: continuation or redirection of ongoing 
projects; incorporation of additional expertise needed for accomplishing 
goals; and future directions.  

The Steering Committee will have access to additional NIH funds to 
support: 1) Innovative Pilot Projects; 2) Clinical Studies; and 3) 
Cooperative Resources in order to accomplish the goals of the Study 
Group.  The Steering Committee’s responsibility to conduct and oversee 
Innovative Pilot Projects, Clinical Studies, and Cooperative Resources 
is intended to encourage cooperative, collaborative, and directed 
efforts of the participating members.  

Adjunct Clinical Studies Subcommittee

The Steering Committee shall appoint an Adjunct Clinical Studies 
Subcommittee to have primary responsibility for assisting the Study 
Group investigators in accessing, developing, designing, and 
implementing clinical studies to investigate the mechanisms of immune 
homeostasis in autoimmune diseased states as well as non-diseased states 
and the mechanisms of preventive strategies in humans.  The Clinical 
Studies Subcommittee will be responsible for reviewing and making 
recommendations to the Steering Committee with regard to the 
implementation of clinical studies proposed by Study Group Members, and 
for coordinating these studies to facilitate collaboration and efficient 
use of clinical samples.  Clinical studies approved in the initial 
application will not require Steering Committee approval but will 
undergo progress reviews.  The members of the Clinical Studies 
Subcommittee shall include one NIH representative as well as 
representatives selected by the Principal Investigators, with each site 
appointing one member.  Each member will have one vote.  The Chair of 
the Adjunct Clinical Studies Subcommittee will be elected from among the 
non-federal members and shall serve as a voting member of the Steering 
Committee.  The Subcommittee will meet in conjunction with Steering 
Committee meetings.  Subcommittee members will be expected to 
participate in all Subcommittee meetings and in other Subcommittee 
activities.  

Study Group Plan

The Steering Committee shall develop the Study Group Plan, which will 
articulate the goals, specify the approaches, and define milestones for 
the activities of the Study Group in understanding immune homeostasis in 
diseased and non-diseased states, the consequences of manipulation of 
immune responses, and the development of strategies for the prevention 
of autoimmune diseases. The Plan shall include procedures and criteria 
for reviewing and for assessing progress on an annual basis and in 
developing recommendations for future directions.  The Steering 
Committee will submit a draft Study Group Plan to the NIH within 3 
months of award, and the final plan within 6 months of award.  

Innovative Pilot Projects

Innovative Pilot Projects will be an integral part of this program.  
Proposals from Study Group members for innovative, exploratory, high-
risk/high-yield, novel, and/or pilot research to advance the goals of 
the Study Group will be supported with resources available to the 
Steering Committee.  The Steering Committee will develop procedures for 
the submission of proposed pilot projects, and criteria for the 
evaluation and selection of pilot projects to be implemented by the 
Study Group.  The Steering Committee may approve more than one 
Innovative Pilot Project at any single Study Group site.  Innovative 
Pilot Projects may be funded for a period of 6 months up to a maximum of 
2 years duration with budgets ranging from $50,000 to approximately 
$150,000 total costs per year as recommended by the Steering Committee. 

Clinical Studies

It is anticipated that many opportunities for new clinical studies will 
arise within the Study Group as a result of new collaborations, expanded 
access to patients and clinical samples, and development of new 
hypotheses relevant for human autoimmune disease.  To capitalize on 
these anticipated opportunities, additional clinical studies will be 
supported with resources available to the Steering Committee.  Clinical 
studies must address the goals of the Study Group, including 
investigation of the mechanisms of autoimmune disease, development 
and/or validation of biomarkers of disease risk, and/or delineation of 
the mechanisms underlying preventive strategies.  This program will 
support only very limited phase 1 trials of the safety, toxicity or 
efficacy of candidate prevention approaches, which result from the 
research within this program.  Clinical trials may not be submitted in 
the initial application and must be submitted and approved by the 
Steering Committee as clinical studies.  If agents show promise, phase 
II and phase III clinical trials can be funded through collaborative 
arrangements with other programs, including the Autoimmunity Centers of 
Excellence, the Immune Tolerance Network, or the Diabetes Prevention 
Trial-Type 1/Diabetes TrialNet.  The Adjunct Clinical Studies 
Subcommittee will be responsible for reviewing and evaluating proposals 
for additional clinical studies and making recommendations to the 
Steering Committee for proposals to be implemented by the Study Group.  
The Subcommittee will establish procedures and criteria for the 
submission and evaluation of proposed clinical studies, and will assist 
in study development, design, implementation, coordination, and 
analysis.  All clinical trials will be reviewed and monitored by the 
appropriate NIAID Data and Safety Monitoring Board.
 
Cooperative Resources

The Steering Committee will establish and support Cooperative Resources 
that provide central assistance and technical expertise for the projects 
undertaken by the Study Group investigators.  These Cooperative 
Resources will provide reagents and services, as needed, to all members 
of the Study Group.  The Steering Committee will determine procedures 
for the designation of Cooperative Resources, and will determine the 
scope of work and level of support based on Study Group requirements.  
Non-administrative cores proposed by individual members of the Study 
Group in the application may be expanded by the Steering Committee to 
become Cooperative Resources.  Cooperative Resources may be housed at 
Study Group member sites or supported through a subcontract to other 
facilities.  

Coordination with other NIH-sponsored programs

The Cooperative Study Group will coordinate their efforts with other 
NIH-funded programs.  Information obtained by the Cooperative Study 
Group will facilitate the design of clinical trials of preventive 
agents.  Equally, ongoing or planned clinical trials offer a unique 
source of patient samples for human immune response studies by Study 
Group investigators.  NIH-sponsored programs that support clinical 
trials in autoimmune diseases include, but are not limited to, the 
Immune Tolerance Network, the Autoimmunity Centers of Excellence, and 
the Diabetes Prevention Trial-Type 1/Diabetes TrialNet.

Intellectual Property

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 Study Group Steering Committee will be asked to develop a 
policy on publication and sharing of data obtained by the collaborative 
efforts of the Study Group. 


3. NIH Staff Responsibilities

NIH staff assistance will be provided by Chief of the Autoimmunity 
Section, Clinical Immunology Branch, Division of Allergy, Immunology and 
Transplantation, NIAID and the Chief of the Molecular and Structural 
Immunology Section, Basic Immunology Branch, Division of Allergy, 
Immunology and Transplantation, NIAID, who will serve as NIH Scientific 
Coordinators.  The NIH Scientific Coordinators will have substantial 
scientific/programmatic involvement along with representatives of the 
other sponsoring organizations during the conduct of this activity 
through technical assistance, advice and coordination above and beyond 
normal program stewardship for grants, as described below.

The NIH Scientific Coordinators along with representatives of the other 
sponsoring organizations will attend all Steering Committee meetings and 
participate in other Committee activities, including, but not limited 
to, development of the Study Group Plan, review and approval of 
Innovative Pilot Projects, Clinical Studies, and Cooperative Resources 
to be supported.  The NIH Scientific Coordinators and representatives of 
the sponsoring organizations will share one vote.

The NIH Scientific Coordinators and representatives of the sponsoring 
organizations will participate in the Adjunct Clinical Studies 
Subcommittee activities, including the evaluation, approval, and 
guidance of clinical studies that require the consent of the Steering 
Committee.  They will share one vote.  

The NIH Scientific Coordinators will provide expertise in: technology 
and resource development, availability, and application; development, 
design, and implementation of clinical studies; policies and procedures 
for the protection of human subjects; and serve as a liaison to the 
Immune Tolerance Network, Autoimmunity Centers of Excellence, and the 
Diabetes Prevention Trial-Type 1/Diabetes TrialNet to facilitate 
collaboration and coordination between the development of prevention 
strategies within the Study Group and the testing of interventions 
within these other NIH-sponsored programs.  

Organizational Changes

Certain organizational changes require the prior written approval of the 
NIAID Scientific Coordinators. These changes include the 
addition/substitution/removal of a principal investigator.  A change in 
the designated principal investigator, or in any key personnel 
identified in the application, must have the prior written approval of 
the NIAID Grants Management Specialist in consultation with the NIAID 
Scientific Coordinators. 

Program Review

The NIH Scientific Coordinators and representative of the sponsoring 
organizations will review the progress of the Cooperative Study Group 
through consideration of annual progress reports, periodic reports on 
ongoing progress, findings, and future plans presented during meetings 
and conference calls, publications, site visits, etc.  

4.  Collaborative Responsibilities

Collaborative responsibilities are as detailed above in this section on 
Terms and Conditions of Award under “Awardee Rights and 
Responsibilities” for the:
o  Steering Committee;
o  Study Group Plan;
o  Innovative Pilot Projects;
o  Clinical studies;
o  Cooperative Resources; and,
o  Intellectual Property

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.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

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 
biomedical and behavioral research projects involving human subjects, 
unless a clear, compelling rationale, and justification are provided 
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 research involving human subjects should 
read the updated "NIH Guidelines for Inclusion of Women and Minorities 
as Subjects in Clinical Research," August 2000 at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html. The 
revisions relate to NIH defined Phase III clinical trials and require: 
a) all applications or proposals and/or protocols to 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) all investigators to report accrual and 
conduct and report analyses, as appropriate, by sex/gender and/or 
racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS:

It is the policy of NIH 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 was published in 
the NIH Guide for Grants and Contracts, March 6, 1998, and which is 
available at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators may obtain copies from these sources or from Dr. Elaine 
Collier or Dr. Charles Hackett (listed in INQUIRIES below) who may also 
provide additional relevant information concerning the policy.

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.  Reviewers are cautioned that 
their anonymity may be compromised when they directly access an Internet 
site.

LETTER OF INTENT

Prospective applicants are asked to submit, by December 15, 2000, a 
letter of intent that includes a descriptive title of the overall 
proposed research, the name, address and telephone number of the 
Principal Investigator, and the number and title of this RFA.  Although 
the letter of intent is not required, is not binding, does not commit 
the sender to submit an application, and does not enter into the review 
of subsequent applications, the information that it contains allows 
NIAID staff to estimate the potential review workload and to plan the 
review.

The letter of intent is to be sent to Dr. Madelon Halula (see address 
under INQUIRIES) by the letter of intent receipt date listed.

APPLICATION PROCEDURES  

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 via 
the web at: http://www.niaid.nih.gov/ncn/grants/multibron.htm.

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants. Application kits are available at most 
institutional offices of sponsored research and from the Division of 
Extramural Outreach and Information Resources, National Institutes of 
Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, 
telephone (301) 435-0714, email: GrantsInfo@nih.gov. Applications are 
also available on the World Wide Web at 
http://grants.nih.gov/grants/forms.htm.

Applications must be received by February 26, 2001.

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. 4/98) Application Kit as modified in, and superseded by, the NIAID 
BROCHURE ENTITLED "INSTRUCTIONS FOR APPLICATIONS FOR MULTI-PROJECT 
AWARDS", and by SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN 
RESPONSE TO THIS RFA will be judged non-responsive and will be returned 
to the applicant. 

For purposes of identification and processing, item 2a on the face page 
of the application must be marked “YES” and the RFA number “AI-00-016” 
and the words “COOPERATIVE STUDY GROUP FOR AUTOIMMUNE DISEASE 
PREVENTION” must be typed in.

The RFA label and line 2 of the application should both indicate the RFA 
number.  The RFA label must be affixed to the bottom of the face page.  
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.

The sample RFA label available at:  
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
has been modified to allow for this change.  Please note this is in pdf 
format.

Submit a signed, typewritten original of the application, including the 
checklist, and three signed, exact, single-sided 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 mail or 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 
Dr. Madelon Halula listed in “Inquiries,” below.

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.

Applicants from institutions that have a General Clinical Research 
Center (GCRC) funded by the NIH National Center for Research Resources 
may wish to identify the GCRC as a resource for conducting the proposed 
research.  If so, a letter of agreement from either the GCRC program 
director or principal investigator could be included with the 
application.

SPECIAL INSTRUCTIONS FOR COMPLETION OF APPLICATIONS IN RESPONSE TO THIS 
RFA

Page limitations for all applications will be 25 pages for the 
scientific plan of each project; 2-5 pages for innovative projects; 10 
pages for cores. 

Applications may be submitted by single institutions or consortia of 
institutions as may be appropriate to provide the requisite types of 
expertise.  All applications must include the information and materials 
specified under item "B. Minimum Requirements for Application."    

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 at: 
http://www.niaid.nih.gov/ncn/grants/multibron.htm.

This brochure presents specific instructions for sections of the PHS 398 
(rev. 4/98) application form that should be completed differently than 
usual.

REVIEW CONSIDERATIONS  

Review Procedures  

Upon receipt, applications will be reviewed for completeness by the NIH 
Center for Scientific Review and for responsiveness by NIAID staff.  
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 NIH in accordance with the review criteria 
stated below.  As part of the initial merit review, all applications 
will receive a written critique and undergo a process in which only 
those applications deemed to have the highest scientific merit, 
generally the top half of the applications under review, will be 
discussed, assigned a priority score, and receive a second level review 
by the National Advisory Councils of the sponsoring NIH Institutes. 

Review Criteria  

The general criteria for U19 multiproject cooperative agreement 
applications are presented in the NIAID brochure,  INSTRUCTIONS FOR 
APPLICATIONS FOR MULTI-PROJECT AWARDS, available at: 
http://www.niaid.nih.gov/ncn/grants/multibron.htm

Additional review criteria specific to this RFA are:

Applicants must comply with the SPECIAL REQUIREMENTS and Minimum 
Requirements for Application (See above).  

Schedule  

Letter of Intent Receipt Date:  December 15, 2000  
Application Receipt Date:       February 26, 2001  
Scientific Review Date:         June 2001 
Advisory Council Date:          October, 2001  
Earliest Date of Award:         August 15, 2001

AWARD CRITERIA

Funding decisions will be made on the basis of scientific and technical 
merit as determined by peer review, program balance, and the 
availability of funds.

INQUIRIES

Written and telephone inquiries concerning this RFA are encouraged.  The 
opportunity to clarify any issues or questions from potential applicants 
is welcome.  

Requests for the NIAID brochure "INSTRUCTIONS FOR APPLICATIONS FOR 
MULTI-PROJECT AWARDS" as well as inquiries regarding programmatic 
(research scope and eligibility) issues, may be directed to:

Elaine Collier, M.D. 
Chief, Autoimmunity Section
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases  
Room 5135, MSC-7640
6700-B Rockledge Drive
Bethesda, MD  20892-7640
Telephone:  (301) 496-7104
FAX:        (301) 402-2571
E-Mail:     ec5x@nih.gov

Charles J. Hackett, Ph.D. 
Chief, Molecular and Structural Immunology Section
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases  
Room 5139, MSC-7640
6700-B Rockledge Drive
Bethesda, MD  20892-7640
Telephone:  (301) 496-7551
FAX:        (301) 402-2571
E-Mail:     ch187q@nih.gov

Joan Harmon, Ph.D.
Senior Advisor for Diabetes 
Division of Diabetes, Endocrinology and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Blvd., Room 697
Bethesda, MD 20892- 
TEL:   301 594-8813
FAX:   301 480-3503
Email: joan_harmon@nih.gov

Dr. Gilman Grave
Chief, Endocrinology Nutrition & Growth Branch
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 4B11A, MSC 7510
Bethesda, MD 20892-7510
Phone: (301) 496-5593
FAX:  (301) 480-9791
Email: graveg@exchange.nih.gov

Susana Serrate-Sztein, M.D.
Rheumatic Diseases Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Natcher Bldg. Rm. 5A25
Bethesda MD 20892-6500
Telephone: (301) 594-5032
FAX (301) 480-4543
Email: szteins@mail.nih.gov

Kenneth A. Gruber, Ph.D.
Chief, Chronic & Disabling Diseases Branch
Division of Extramural Research
National Institute of Dental and Craniofacial Research
Room 4AN-18C, Bldg 45
Bethesda, MD 20892
Tel: 301-594-4836
FAX: 301-480-8318
Email: kenneth_gruber@nih.gov

Direct inquiries regarding preparation of the application and review 
issues, address the letter of intent to, and mail two copies of the 
application and all five sets of appendices to:  

Dr. Madelon Halula  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 2150, MSC-7616
6700-B Rockledge Drive 
Bethesda, MD  20892-7616
Telephone:  (301)402-2636  
FAX:        (301) 402-2638)
Email:      mhalula@niaid.nih.gov

Direct inquiries regarding fiscal matters to the following Institute 
contacts:  

Pamela Fleming  
Division of Extramural Activities  
National Institute of Allergy and Infectious Diseases  
Room 2119, MSC-7614
6700-B Rockledge Drive  
Bethesda, MD  20892-7614  
Telephone:  (301) 402-6580
FAX:        (301) 480-3780  
E-mail:     pfleming@niaid.nih.gov

Florence Danshes
Division of Extramural Affairs
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room 634
Bethesda, MD 20892-5456
Telephone: (301) 594-8861
FAX:  (301) 480-3504
Email: danshesf@extra.niddk.nih.gov

E. Douglas Shawver
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17
Bethesda, MD 20892-7510
Telephone:   (301) 496-1303
FAX:          (301) 402-0915
Email:  shawverd@hd01.nih.gov

Melinda Nelson
Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Natcher Bldg. Rm. 5A49
Bethesda MD 20892-6500
Telephone:   (301) 594-3535
FAX:         (301) 480-5450
Email: mn23z@nih.gov

Martin R. Rubinstein
Division of Extramural Research
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-44A
Bethesda, MD  20892-6402
Telephone:   (301) 594-4800
Fax:         (301) 480-8301
Email:  Martin.Rubinstein@nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalogue of Federal Domestic 
Assistance No. 93.855 - Immunology, Allergy, and Transplantation 
Research, No. 93.865 – Research for Mothers and Children, No. 93.846, 
Arthritis, Musculoskeletal and Skin Diseases Research, No. 93-847 – 
Diabetes, Endocrinology, and Metabolic Diseases, and No. 93.121 – Oral 
Diseases and Disorders 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 Public Health Service strongly encourages all grant and contract 
recipients to provide a smoke-free workplace and promote the non-use of 
all tobacco products. In addition, Public Law 103-227, the Pro-Children 
Act of 1994, prohibits smoking in certain facilities (or, in some cases, 
any portion of a facility) in which regular or routine education, 
library, day care, health care or early childhood development services 
are provided to children.  This is consistent with the PHS mission to 
protect and advance the physical and mental health of the American 
people.


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NIH Funding Opportunities and Notices


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