NIH GUIDE, Volume 21, Number 11, March 20, 1992

PA NUMBER:  PA-92-54

P.T. 34



  Immune Enhancers 

  Growth Factors 


National Institute of Allergy and Infectious Diseases


The Division of Allergy, Immunology and Transplantation (DAIT) of the

National Institute of Allergy and Infectious Diseases (NIAID), a

component of the National Institutes of Health (NIH), invites research

project grant applications (R01 and R29) for support of basic studies

on the involvement of cytokines in the immunopathogenesis of autoimmune

diseases and on their use as modulators of disease initiation and



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 Program

Announcement, Cytokines in Autoimmunity, is related to the priority

area of diabetes and chronic disabling diseases. Potential applicants

may obtain a copy of "Healthy People 2000" (Full Report:  Stock No.

017-001-00474-0) or "Healthy  People 2000" (Summary Report:  Stock No.

017-001-00473-1) through the Superintendent of Documents, Government

Printing Office, Washington, DC 20402-0325 (telephone 202-783-3238).


Research grant 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 or

local governments, and eligible agencies of the Federal Government.

Applications from minority individuals and women are encouraged.

Foreign institutions are not eligible to apply for the First

Investigator Research Support Transition (FIRST) Award (R29).


The mechanisms of support will be the individual research project grant

(R01) and the First Investigator Research Support Transition (FIRST)

Award (R29).  Policies that govern research grant programs of the

National Institutes of Health will prevail.


During the last ten years, there have been great advances in the

understanding of the biology and biochemistry of cytokines and of the

mechanisms leading to autoimmune diseases.  However, the precise role

that cytokines have in susceptibility to, and promotion, initiation,

and perpetuation of, autoimmune responses and induction of tissue

injury remain largely unknown.  One of the goals of the NIAID in this

area is to promote research to achieve a better understanding of the

pathogenic role of cytokines in self reactivity and autoimmune

diseases.  This knowledge will make a critical contribution to advance

the opportunities for the development of new, specific and effective

therapies for autoimmune diseases.

Areas of interest include:

o  Identification and characterization of known and newly discovered

cytokines involved in proliferation and function of autoreactive B


o  Analysis of cytokine involvement in the regulation of MHC

molecule-self peptide expression in lymphoid cells and target tissues

o  Regulation of autoreactive T-cell functions by cytokines

o  Studies of cytokine effects on the generation and function of CD5+

B cells

o  Characterization of cytokine production and cytokine responses in

monocytes and macrophages from autoimmune individuals

o  Research on cytokine signal transduction pathways in autoreactive


o  Studies on the role of cytokines in the induction or acceleration of

disease in the autoimmune prone host

o  Studies on cytokine receptor modulation as a means of affecting

disease development

o  Identification of the cytokine cascades leading to focal


o  Effects of cytokines and cytokine antagonists in tissue injury and

repair during autoimmune diseases





NIH and ADAMHA policy is that applicants for NIH/ADAMHA clinical

research grants and cooperative agreements are required to include

minorities and women in study populations so that research findings can

be of benefit to all persons at risk of the disease, disorder or

condition under study; special emphasis must be placed on the need for

inclusion of minorities and women in studies of diseases, disorders and

conditions that disproportionately affect them.  This policy is

intended to apply to males and females of all ages.  If women or

minorities are excluded or inadequately represented in clinical

research, particularly in proposed population-based studies, a clear

compelling rationale must be provided.

The composition of the proposed study population must be described in

terms of gender and racial/ethnic group.  In addition, gender and

racial/ethnic issues should be addressed in developing a research

design and sample size appropriate for the scientific objectives of the

study.  This information must be included in the form PHS 398 in

Section 2, 1-4 of the Research Plan AND summarized in Section 2, E.

Human Subjects.  Applicants/offerors are urged to assess carefully the

feasibility of including the broadest possible representation of

minority groups.  However, NIH recognizes that it may not be feasible

or appropriate in all research projects to include representation of

the full array of United States racial/ethnic minority populations

(i.e., Native Americans (including American Indians or Alaskan

Natives), Asian/Pacific Islanders, Blacks, Hispanics).  The rationale

for studies on single minority population groups must be provided.

For the purpose of this policy, clinical research is defined as human

biomedical and behavioral studies of etiology, epidemiology, prevention

(and preventive strategies), diagnosis, or treatment of diseases,

disorders or conditions, including but not limited to clinical trials.

The usual NIH policies concerning research on human subjects also

apply.  Basic research or clinical studies in which human tissues

cannot be identified or linked to individuals are excluded.  However,

every effort should be made to include human tissues from women and

racial/ethnic minorities when it is important to apply the results of

the study broadly, and this should be addressed by applicants.

For foreign awards, the policy on inclusion of women applies fully;

since the definition of minority differs in other countries, the

applicant must discuss the relevance of research involving foreign

population groups to the United States' populations, including


If the required information is not contained within the application,

the review will be deferred until the information is provided.

Peer reviewers will address specifically whether the research plan in

the application conforms to these policies.  If the representation of

women or minorities in a study design is inadequate to answer the

scientific question(s) addressed AND the justification for the selected

study population is inadequate, it will be considered a scientific

weakness or deficiency in the study design and will be reflected in

assigning the priority score to the application.

All applications for clinical research submitted to NIH are required to

address these policies.  NIH funding components will not award grants

or cooperative agreements that do not comply with these policies.


Applicants are to use the standard research grant application form PHS

398 (rev. 9/91).  For purposes of identification and processing, check

yes on item 2 of the face page and enter the title:  "PA-92-54:

Cytokines in Autoimmunity".  Applications will be accepted in

accordance with the standard submission dates for new applications:

February 1, June 1, and October 1.

Application kits are available at most institutional business offices

and may be obtained from the Office of Grants Inquiries, Division of

Research Grants, Westwood Building, Room 449, National Institutes of

Health, Bethesda, MD 20892, telephone (301) 496-7441.

The completed original application and five legible copies must be sent

or delivered to:

Division of Research Grants

National Institutes of Health

Westwood Building, Room 240

Bethesda, MD  20892**


Applications will be assigned on the basis of established Public Health

Service referral guidelines.  Applications will be reviewed for

scientific and technical merit by study sections of the Division of

Research Grants, NIH, in accordance with the standard NIH peer review

procedures.  Following scientific-technical review, the applications

will receive a second-level review by an appropriate national advisory

council or board.


Applications will compete for available funds with all other approved

applications.  The following will be considered in making funding

decisions: quality of the proposed project as determined by peer

review, availability of funds, and program balance among research areas

of the announcement.


Requests for additional information or questions regarding the


aspects of this PA may be directed to:

Dr. S. Serrate-Sztein

Division of Allergy, Immunology and Transplantation

National Institute of Allergy and Infectious Diseases

Solar Building, Room 4A20

Bethesda, MD 20892 (20852 if using overnight delivery services)

Telephone:  (301) 496-7985


Dr. M. Michele Hogan

Division of Allergy, Immunology and Transplantation

National Institute of Allergy and Infectious Diseases

Solar Building, Room 4A20

Bethesda, MD 20892 (20852 if using overnight delivery services)

Telephone:  (301) 496-7551

FAX:  (301) 402-0175

Direct inquiries regarding fiscal matters to:

Mr. Jeffrey Carow

Chief, Immunology Grants Management Section, GMB, DEA

National Institute of Allergy and Infectious Diseases

Solar Building, Room 4B29

Bethesda, MD  20892

Telephone:  (301) 496-7075


This program is described in the Catalog of Federal Domestic

Assistance, No. 93.855 - Immunology, Allergic and Immunologic Diseases

Research.  Grants are awarded under the authority of the Public Health

Service Act, Section 301 (42 USC 241) and administered under PHS grants

policies and Federal Regulations, most specifically at 42 CFR Part 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.


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