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. Sj gren’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 Sj gren’s syndrome, while 2 to 5 % of people aged 60 and above
have primary Sj gren’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 1 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) 710-0267, 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.
Weekly TOC for this Announcement
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