TARGET ORGAN DAMAGE IN AUTOIMMUNE DISEASES

Release Date:  February 26, 1999

RFA:  AR-99-003

P.T.

National Institute of Arthritis and Musculoskeletal, and Skin Diseases
National Institute of Dental and Craniofacial Research
National Institute of Allergy and Infectious Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
National Institute of Child Health and Human Development
National Institute of Environmental Health Sciences
National Institute on Deafness and other Communication Disorders
National Eye Institute
National Heart, Lung and Blood Institute
National Institute of Neurological Disorders and Stroke
National Institute of Mental Health
Office of Research on Women's Health

Letter of Intent Receipt Date:  April 9, 1999
Application Receipt Date:  May 12, 1999

THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  IT INCLUDES
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED
WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA.

PURPOSE

The National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS), the National Institute of Dental and Craniofacial Research (NIDCR), the
National Institute of Allergy and Infectious Diseases (NIAID), the National
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National
Institute of Environmental Health Sciences (NIEHS), the National Institute on
Deafness and other Communication Disorders (NIDCD), the National Eye Institute
(NEI), the National Heart, Lung and Blood Institute (NHLBI), the National
Institute of Neurological Disorders and Stroke (NINDS), the National Institute
of Mental Health (NIMH), and the Office of Research on Women's Health invite
applications for research on the genetic bases and molecular pathways of target
organ damage in rheumatic and autoimmune diseases. The applications may be for
individual research projects (R01), for a group of independent research projects
that use the interactive research project grant (IRPG) mechanism, or for
exploratory/developmental grants (R21).  The research should be specifically
targeted towards identification and evaluation of cellular and molecular pathways
involved in organ damage and on the genetic basis for target organ involvement
in autoimmunity.  This Request for Applications (RFA) solicits basic,
translational and clinical research projects, but not epidemiological or clinical
treatment projects.

HEALTHY PEOPLE 2000

The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This RFA, Target Organ Damage in Autoimmune
Diseases, is related to the priority areas of chronic disabling conditions and
of older adults and preventive services.  Potential applicants may obtain a copy
of "Healthy People 2000" (Full Report:  Stock No. 017-001-00474-0 or Summary
Report:  Stock No. 017-001-00473-1) through the Superintendent of Documents,
Government Printing Office, Washington, DC 20402-9325 (telephone 202-512-1800).

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign for-profit and non-profit
organizations, public and private, such as universities, colleges, hospitals,
laboratories, units of State and local governments, and eligible agencies of the
Federal government.  Racial/ethnic minority individuals, women, and persons with
disabilities are encouraged to apply as Principal Investigators.

MECHANISM OF SUPPORT

This RFA will use the National Institutes of Health (NIH) individual research
grant (R01), interactive research project grants (IRPG), and the
exploratory/developmental grant (R21) mechanisms.  Responsibility for the
planning, direction, and execution of the proposed project will be solely that
of the applicant.  The anticipated award date is September 30, 1999.  Because the
nature and scope of the research proposed in response to this RFA may vary, it
is anticipated that the size of an award will also vary.  This RFA is a one time
solicitation.  Future unsolicited competing continuation applications will
compete with all investigator initiated applications and be reviewed according
to customary peer review procedures.

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 should
be included within the application.

R01 Applications.  R01 awards will vary in size and duration reflecting the
nature and scope of the research proposed.  Future unsolicited competing
continuation applications will compete with all investigator initiated
applications and be reviewed according to customary peer review.

IRPGs.  The IRPG mechanism encourages interaction and collaboration among
independent scientists with common goals.  It is intended to bring together
research projects from investigators who wish to collaborate but who do not
require extensive shared resources.  There should be constructive interchange of
ideas, data and/or materials.  A minimum of two independent investigators are
encouraged to submit concurrent, collaborative, cross-referenced individual
regular research (R01) applications.  These applications must be free-standing
and contain independent hypotheses and aims.  An application that provides only
a service to other applicants is not acceptable.  Applicants may be from one or
several institutions.  Potential applicants contemplating the submission of an
IRPG should contact the program official listed under INQUIRIES as early as
possible.  Guidelines for preparing IRPG applications are available from the
program official or from the internet at:
https://grants.nih.gov/grants/guide/pa-files/PA-96-001.html.

R21 Applications.  Investigators with expertise on the physiology, pathology and
genetics of organs and tissues involved in rheumatic, skin and autoimmune-related
cardiovascular diseases who wish to establish research programs in the context
of autoimmune diseases are encouraged to apply. Also encouraged are investigators
with expertise in immune mechanisms of disease and autoimmunity who wish to
expand their research to mechanisms of target-organ damage.

Exploratory/developmental studies are not intended for large scale undertakings
nor to support or supplement ongoing research.  Instead, investigators are
encouraged to explore the feasibility of an innovative research question or
approach which may not be justifiable through existing research to compete as a
standard research project grant (e.g., R01), and to develop a research basis for
a subsequent application through other mechanisms, i.e., R01, P01.

Exploratory/developmental (R21) grants, may not exceed $75,000 per year in direct
costs, not including indirect costs for collaborating institutions, if any.  The
total project period for an R21 application submitted in response to this RFA may
not exceed three years.  These grants are non-renewable and continuation of
projects developed under the R21 program will be through the traditional
unsolicited (R01 or P01) grant programs.

FUNDS AVAILABLE

It is anticipated that 10 to 15 awards will be made as a result of this RFA.  
The estimated funds available for the first year of support for the program are
$3.0 M.  Actual funding is contingent upon receipt of a sufficient number of
scientifically meritorious applications.  Funding beyond the first and subsequent
years of the grant will be contingent upon satisfactory progress during the
preceding years and the availability of funds.

RESEARCH OBJECTIVES

Background

Although immune dysregulation plays a major role in the induction of
autoimmunity, recent evidence suggests that structural and functional properties
of target/end organs such as heart and blood vessels, kidneys, synovium, skin,
thryroid gland and islet cells may contribute significantly to the development
of tissue damage and clinical disease. Some of the deleterious effects of
autoreactivity are likely due to interactions between antibodies and specific
cellular elements in the target organ beyond the activation of the complement
cascade.  For example, autoantibodies may bind to cell surface receptors, and
trigger cell activation, modify cell function or induce apoptosis. Relatedly,
some of the deleterious effects of autoreactivity may also be due to interactions
between cells, such as, sensitized T cells, and associated cytokines, within the
target organ.  For example, sensitized T cells may trigger cell death and induce
the release of proinflammatory cytokines which then may activate cells and alter
cell functions.  Further, the type of interaction may influence clinical
expression and may relate to the observed differences in organ involvement among
patients with the same diseases.  In lupus nephritis, pathogenic immunoglobulins
produce distinguishable deposit patterns in specific glomerular locations and
this is associated with different disease profiles.  The differences appear to
be based on the differential reactivity of the autoantibodies with specific
glomerular antigens, suggesting that antigen display in the target organ
influences tissue damage.

The genetic mapping of susceptibility genes in diabetes and lupus also suggest
an important role of the target organ in the induction of tissue injury, with
contributions made by the cellular components and their interactions with the
extracellular matrix, independent of other known factors such as HLA. For
example, in murine models of systemic lupus, nephritis is differentially induced
in different strains of mice, in spite of similar autoantibody profiles and in
the presence of similar T cell reactivity.  Recent data from genetic analysis of
backcrosses of autoimmune prone mice in a model of autoimmune myocarditis also
suggests that genetic factors unrelated of immune-related susceptibility loci are
important in the development and severity of symptoms.

In studies of rheumatoid arthritis synovium, specific mutations in the p53 genes
have been found and cultured synoviocytes from rheumatoid arthritis patients
over-express certain pro-inflammatory genes that are potentially relevant to
lymphocyte and monocyte entry and interactions. The features of the genes
identified in these mesenchymal cells suggest that they facilitate localization
of immune reactions to the joint through leukocyte chemokinesis, cell-cell
adhesion, and matrix specialization.  These results suggest that intrinsic
lineage characteristics of cellular components of the target organ contribute to
the character and possibly the intensity of the local immuno-inflammatory
responses.

An autoimmune basis has been implicated in a number of cardiac diseases including
rheumatic fever and myocarditis.  In order to shed more light on the pathogenesis
and etiology of this disease, additional studies are needed on identifying the
basis of genetic predisposition to the disease, the role of cytokines, viral
persistence, and the contribution of cardiac dendritic cells.

Both patients with diabetes mellitus and with systemic lupus erythematosus (SLE)
are at higher risk of heart disease than the general population.  Diabetes
mellitus is a well-established major independent risk factor for coronary artery
disease and peripheral vascular disease.  In lupus, up to 50-60% of the patients
have cardiac diseases such as endocarditis and pericarditis.  A better
understanding of the cardiac pathogenesis in these patients would lead to better
treatment and possible prevention of cardiac disease progression.  In addition,
investigating the role of autoimmunity in atherosclerosis may shed new light on
the etiology of syndromes such as systemic lupus erythematosus, an autoimmune
disease in which death from coronary artery disease is increased.  The mechanisms
whereby heat shock proteins exacerbate lesion development, for example by binding
to components derived from oxLDL thereby enhancing their antigenicity, is an
under-investigated area that requires further study.

Idiopathic pulmonary fibrosis is associated with autoimmune diseases and can be
the leading cause of death. Autoantibodies are found in association with
idiopathic pulmonary fibrosis.  The role for a unique tissue environment and
factors have been cited as an important elements of the development of the
autoimmune response.  Given the exposure of the lung to viruses and the role for
dysregulated inflammation in interstitial lung diseases, the possible role for
an autoimmune response in initiating or perpetuating the inflammation is
potentially an important aspect of these diseases.

Scope

The purpose of this Request for Applications is to stimulate innovative and
multidisciplinary studies of immune and non-immune mechanisms of induction and
development of injury and dissection of the genetics of target organ involvement
in the context of rheumatic and autoimmune diseases.  Relevant diseases covered
under this RFA include lupus, rheumatoid arthritis, scleroderma,  Sjogren's
disease, autoimmune skin diseases such as pemphigus and psoriasis, rheumatic
fever and myocarditis, myositis and dermatomyositis, juvenile rheumatic diseases,
autoimmune thyroid disease, insulin dependent diabetes mellitus, multiple
sclerosis and other autoimmune diseases of the central and peripheral nervous
system, celiac disease, inflammatory bowel disease, and autoimmune disease of the
liver, autoimmune diseases involving the eye and the inner ear, and autoimmune
kidney disease.  New methodologies to facilitate studies of gene expression and
characterization of the phenotype of involved tissues are needed.  Knowledge
gained by research in this area will make it possible to construct a more
comprehensive picture of disease pathogenesis.  Definition of discrete pathogenic
processes involving the target organs may provide the scientific rationale for
new forms of interventions.

Appropriate research areas may include, but are not limited to, the following:

o Development and evaluation of new experimental systems, including the
generation of transgenic and other genetically-engineered animal models to study
cellular, molecular, environmental, and genetic aspects of target organ
involvement.

o Development of new in vitro models to analyze the effects of inflammatory,
immune and other mechanisms of injury on target organ/cell function and
structure.

o Identification and characterization of cellular and molecular pathways involved
in target/end organ damage including damage caused by environmental agents.

o Mechanistic studies on the initiation and perpetuation of local immune and
inflammatory responses that occur in organs involved in autoimmune diseases.

o Studies on the changes in target organ structure and function due to the
presence of local immune, inflammatory and other forms of tissue injury related
to the autoimmune disease.

 o Studies on the effects of autoreactive or other relevant immune or
inflammatory responses on target/end organ repair processes.

o Studies of mechanisms underlying phenotypic changes in cellular components of
target organs during different phases of the disease.

o Identification of biochemical, structural or other markers that may correlate
with early, preclinical target organ involvement and that may predict disease
progression or severity.

o  Analysis of environmental, genetic, and immune factors that determine the
particular target organ involved.

o Studies to identify mediators and mechanisms that may either protect or
exacerbate target organs from the inflammatory, immune and other forms of tissue
injury involved in autoimmune diseases.

o Atherogenic determinants in autoimmune diseases such as lupus and anti-
phospholipid antibody syndromes. Such studies could include neoepitope formation
occurring as a result of oxidative modification of lipoproteins, phospholipids,
or fatty acids, as well as studies to establish the significance of
autoantibodies to lipoprotein oxidation products.

o  The role of heat shock proteins in atherogenesis, the nature of hsp
interactions with products of lipid metabolism and how and whether they
contribute to the immunogenicity of such products and the regulation of hsp gene
expression in vascular cells.

This list is intended to be illustrative and not exclusive or restrictive. 
Applications combining interdisciplinary approaches that include collaborations
between autoimmune disease researchers and experts in other related scientific
fields such as nephrology, neurology, etc. are strongly encouraged.

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
subpopulations must be included in all NIH supported biomedical and behavioral
research projects involving human subjects so that research findings can be of
benefit to all persons at risk of the disease, disorder or condition under study. 
If women or minorities are excluded or inadequately represented a clear
compelling rationale must be provided.  All investigators proposing research
involving human subjects should read the "NIH Guidelines For Inclusion of Women
and Minorities as Subjects in Clinical Research," which have been published in
the Federal Register of March 28, 1994 (FR 59 14508-14513) and reprinted in the
NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994.  This
information is available on the internet at
https://grants.nih.gov/grants/guide/notice-files/not94-100.html.

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 is available at the following URL address:
https://grants.nih.gov/grants/guide/notice-files/not98-024.html

LETTER OF INTENT

Prospective applicants are asked to submit, by April 9, 1999, a letter of intent
that includes a title of the proposed research, the name, address, and telephone
number of the Principal Investigator, the identities of other key personnel and
participating institutions, and the number and title of the RFA in response to
which the application may be submitted.  Although a letter of intent is not
required, is not binding, and does not enter into the review of subsequent
applications, the information that it contains allows program staff to estimate
the potential review workload and to avoid conflict of interest in the review.

The letter of intent is to be sent to:

Tommy L. Broadwater, Ph.D.
Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-25U, MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-4952
FAX:  (301) 480-4543
Email: broadwater@nih.gov

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in applying
for these grants.  These forms are available at most institutional offices of
sponsored research; 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, e mail: GRANTSINFO@NIH.GOV.

The RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application.  Failure to use this
label could result in delayed processing of the application such that it may not
reach the review committee in time for review.  In addition, the RFA title and
number must be typed on line 2a of the face page of the application form and the
YES box must be marked.

This solicitation uses Modular Grant Application and Award.  In modular grant
applications, total direct costs not exceeding $250,000 per year will be
requested in $25,000 increments instead of being compiled from detailed and
separate budget categories.  The implementation of modular application, review
and award procedures is described in 
https://grants.nih.gov/grants/guide/notice-files/not98-178.html

In preparing Modular Grant Applications, standard instructions for specific award
mechanisms should be followed: [PHS 398 (R01,R21)] with these specific
modifications reflecting modular budget and just-in-time concepts:

PHS 398

o  FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total
Direct plus Facilities and Administrative (F&A) costs] for the initial budget
period.  Items 8a and 8b should be completed indicating the Direct and Total
Costs for the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4
of the PHS 398.  It is not required and will not be accepted with the
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the
categorical budget table on Form Page 5 of the PHS 398.  It is not required and
will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION - Use a Modular Grant Budget Narrative page.
(See https://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.)

At the top of the page, enter the total direct costs requested for each year.

o  Under Personnel, list key project personnel, including their names, percent
of effort, and roles on the project. No individual salary information should be
provided.

For Consortium/Contractual costs, provide an estimate of total costs (direct plus
facilities and administrative) for each year, each rounded to the nearest $1,000.
List the individuals/organizations with whom consortium or contractual
arrangements have been made, the percent effort of key personnel, and the role
on the project.  Indicate whether the collaborating institution is foreign or
domestic.  The total cost for a consortium/ contractual arrangement is included
in the overall requested modular direct cost amount.

Provide an additional narrative budget justification for any variation in the
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by
reviewers in the assessment of each individual's qualifications for a specific
role in the proposed project, as well as to evaluate the overall qualifications
of the research team.  A biographical sketch is required for all key personnel,
following the instructions below. No more than three pages may be used for each
person.  A sample biographical sketch may be viewed at:
https://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page; - List current
position(s) and then previous positions;
- List selected peer-reviewed publications, with full citations; - Provide
information, including overall goals and responsibilities, on research projects
ongoing or completed during the last three years.

o  CHECKLIST - This page should be completed and submitted with the application.

If the F&A rate agreement has been established, indicate the type of agreement
and the date. It is important to identify all exclusions that were used in the
calculation of the F&A costs for the initial budget period and all future budget
years.

Additional information, including sample budget narratives and biographical
sketch, may be found at this site:
https://grants.nih.gov/grants/funding/modular/modular.htm.

Submit a signed original of the application, including the Checklist, and three
signed copies in one package to:

CENTER FOR SCIENTIFIC REVIEW
NATIONAL INSTITUTES OF HEALTH
6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC-7710
BETHESDA, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application must also be
sent to:

Tommy L. Broadwater, Ph.D.
Scientific Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-25U, MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-4952
FAX:  (301) 480-4543
Email:  broadwater@nih.gov

Applications must be received by May 12, 1999.  If an application is received
after that date, it will be returned to the applicant without review.  The Center
for Scientific Review (CSR) will not accept any application in response to this
RFA that is essentially the same as one currently pending initial review, unless
the applicant withdraws the pending application.  The CSR will not accept any
application that is essentially the same as one already reviewed.  This does not
preclude the submission of substantial revisions of applications already
reviewed, but such applications must include an introduction addressing the
previous critique.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the CSR and
responsiveness by the Institute staff.  Incomplete applications will be returned
to the applicant without further consideration.  If the application is not
responsive to the RFA, NIAMS staff will contact the applicant to determine
whether to return the application to the applicant or submit it for review in
competition with unsolicited applications at the next review cycle.

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 NIAMS in accordance with the review criteria stated below.  As part of the
initial merit review, a process will be used by the initial review group in which
applications 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 appropriate national advisory council
or board.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  In the
written comments reviewers will be asked to discuss the following aspects of the
application in order to judge the likelihood that the proposed research will have
a substantial impact on the pursuit of these goals.  Each of these criteria will
be addressed and considered in assigning the overall score, weighting them as
appropriate for each application.  Note that the application does not need to be
strong in all categories to be judged likely to have major scientific impact and
thus deserve a high priority score.  For example, an investigator may propose to
carry out important work that by its nature is not innovative but is essential
to move a field forward.

(1) Significance:  Does this study address an important problem?  If the aims of
the application are achieved, how will scientific knowledge be advanced?  What
will be the effect of these studies on the concepts or methods that drive this
field?

(2) Approach:  Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of the
project?  Does the applicant acknowledge potential problem areas and consider
alternative tactics?

(3) Innovation:  Does the project employ novel concepts, approaches or method?
Are the aims original and innovative?  Does the project challenge existing
paradigms or develop new methodologies or technologies?

(4) Investigator:  Is the investigator appropriately trained and well suited to
carry out this work?  Is the work proposed appropriate to the experience level
of the principal investigator and other
researchers (if any)?

(5) Environment:  Does the scientific environment in which the work will be done
contribute to the probability of success?  Do the proposed experiments take
advantage of unique features of the scientific environment or employ useful
collaborative arrangements?  Is there evidence of institutional support?

In addition to the above criteria, in accordance with NIH Policy, all
applications will also be reviewed with respect to the following:

o  The adequacy of plans to include both genders, minorities and their subgroups,
and children as appropriate for the scientific goals of the research.  Plans for
the recruitment and retention of subjects will also be evaluated.

o  The reasonableness of the proposed budget and duration in relation to the
proposed research

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

AWARD CRITERIA

The anticipated date of award is September 30, 1999.

Awards will be based upon the following criteria:

o  scientific merit
o  availability of funds
o  programmatic priorities of the funding IC
o  responsiveness to the RFA

INQUIRIES

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

Direct inquiries regarding programmatic issues to:

Susana Serrate-Sztein, M.D.
Rheumatic Diseases Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-25E, MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-5032
FAX:  (301) 480-4543
Email:  sztein@exhange.nih.gov

Jerrold J. Heindel, Ph.D.
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC  27709
Telephone:  (919) 541-0781
FAX:  (919) 541-5064
Email:  Heindelj@niehs.nih.gov

Elaine Collier, M.D.
Division of Allergy, Immunology, and Infectious Diseases
National Institute of Allergy and Infectious Diseases
6003 Executive Boulevard, Room 4A20
Bethesda, MD  20892-7640
Telephone:  (301) 496-7104
FAX:  (301) 402-2571
Email:  ec5x@nih.gov

Barbara Linder, M.D., Ph.D.
Division of Diabetes, Endocrinology, and Metabolic Diseases
National Institute of Diabetes and Digestive and Kidney Diseases
45 Center Drive, MSC 6600
Bethesda, MD  20892-6600
Telephone:  (301) 594-0021
FAX:  (301) 480-3503
Email:  Linderb@extra.niddk.nih.gov

Karen Winer M.D.
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B11
Rockville, MD  20892
Telephone:  (301) 435-6877
FAX:  (301) 480-9791
Email:  winerk@mail.nih.gov

A. Julianna Gulya, M.D.
Clinical Trials Branch
National Institute on Deafness and Other Communication Disorders
6120 Executive Boulevard, 400D-7 EPS
Rockville, MD  20892
Telephone:  (301) 435-4085
FAX:  (301) 402-6251
Email:  julie_gulya@nih.gov

Ellen Liberman, Ph.D.
National Eye Institute
6210 Executive Boulevard, Suite 350, MSC 7164
Bethesda, MD  20892-7164
Telephone:  (301) 496-0484
FAX:  (301) 402-0528
Email:  ellenliberman@nei.nih.gov

Robert Musson, Ph.D.
National Heart, Lung and Blood Institute
6401 Rockledge Drive, Room 10108, MSC 7952
Bethesda, MD  20892-7952
Telephone:  (301) 435-0222
FAX:  (301) 480-3557
Email:  mussonr@gwgate.nhlbi.nih.gov

Audrey Penn, Ph.D.
National Institute of Neurological Disorders and Stroke
Building 31, Room 8A52, MSC 2540
Bethesda, MD  20892
Telephone:  (301) 496-3167
FAX:  (301) 496-0296
Email:  penna@nswide.ninds.nih.gov

Dianne Rausch, Ph.D.
National Institute of Mental Health
5600 Fishers Lane, Room 18-101
Rockville, MD  20857
Telephone:  (301) 594-8814
FAX:  (301) 480-3503
Email:  drausch@mail.nih.gov

Kenneth A. Gruber, Ph.D.
Chronic and Disabling Diseases Program
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-18C
Bethesda, MD  20892
Telephone:  (301) 594-4836
FAX:  (301) 480-8318
Email:  kenneth_gruber@nih.gov

Vivian Pinn, Ph.D.
Associate Director for Research
Office of Research on Women's Health
Building 1, Room 201
Bethesda, MD  20892
Telephone:  (301) 402-1770
FAX:  (301) 402-1798
Email:  pinnv@od.nih.gov

Direct inquiries regarding fiscal matters to:

Ms. Carol Fitzpatrick
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-43B, MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-3503
FAX:  (301) 480-4543
Email:  fitzpatri@exchange.nih.gov

Schedule

Letter of Intent Receipt Date:  April 9, 1999
Application Receipt Date:       May 12, 1999
Initial Review:                 July 1999
Second Level Review:            September 1999
Anticipated Award Date:         September 30, 1999

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.846, 93.847, 93.113 - Biological Responses to Environmental Health Hazards,
and No. 93.856 - Microbiological and Infectious Disease Research, and No. 93.855
- Immunology, Allergy, and Transplantation Research.  Awards are made under
authorization of the Public Health Service Act, Title IV, Part A (Public Law
78-410), as amended by Public Law 99-158, 42 USC 241 and 285) and administered
under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. 
This program is not subject to the intergovernmental review requirements of
Executive Order 12372 or Health Systems Agency review.

The PHS strongly encourages all grant 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 America people.

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