SMALL GRANT PROGRAM FOR THE NIAMS

Release Date:  September 16, 1998

RFA:  AR-99-001

P.T.

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Application Receipt Date:  January 22, 1999

PURPOSE

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
is seeking small grant (R03) applications to stimulate and facilitate the entry
of promising new investigators into high priority areas of NIAMS research. 
Applications are especially encouraged from new investigators who hold a faculty
position at an Historically Black College or University (HBCU) or other
institutions that have student populations consisting predominantly of
individuals from racial or ethnic groups that are underrepresented in science. 
This one-time solicitation will provide support for pilot research that is likely
to lead to a subsequent individual research project grant (R01).

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 Request for Applications (RFA), Small
Grant Program for the NIAMS, is related to the priority area of chronic diseases. 
Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: 
Stock No. 017-001-11474-0 or Summary Report:  Stock No. 017-001-11473-1) through
the Superintendent of Documents, Government Printing Office, Washington, DC
20402-9325 (telephone 202-512-1800).

ELIGIBILITY REQUIREMENTS
Applications may be submitted by domestic 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.  Foreign
organizations and institutions are not eligible.  Participation in the program
by investigators at minority institutions is strongly encouraged.  Pilot project
grants awarded through this RFA may not be used to support thesis or dissertation
research.

Former and current recipients of NIH small research grants (R03), Academic
Research Enhancement Awards (AREA) (R15), Mentored Clinical Scientist Development
Awards (K08), Mentored Research Scientist Development Awards (K01), Shannon
Awards (R55), or Individual (F32) or Institutional (T32) National Research
Service Award (NRSA) training support are eligible to apply for this Small Grant
Program, dependent upon the status of other support for the project. Any current
support by the F32 or T32 mechanisms must terminate before Small Grant support
begins. The work proposed may not overlap significantly with the aims of
currently supported projects in which the Principal Investigator has participated
during the last five years.  (Information on such projects is to be provided as
part of the Principal Investigator's Biographical Sketch, as described below
under Application Procedures.)

Current and previous recipients of NIH funding through Research Project Grants
(R01), FIRST (R29) awards or any non-mentored career development award mechanism
are ineligible for this Small Grants Program.  Principal Investigators of
research subprojects of Research Program Projects (P01) and Centers (P50 and P60)
and individuals who have received research support from the National Science
Foundation (NSF) or Department of Veterans Affairs (VA) as Principal
Investigators are also ineligible.  Individuals whose sole previous support has
been through pilot and feasibility studies may apply.

Investigators who have questions about eligibility should contact one of the
program officials listed under INQUIRIES.

MECHANISM OF SUPPORT

Applicants may request up to $50,000 (direct costs) per year for up to three
years through the small grant (R03) mechanism.  It is anticipated that grants
would be awarded no later than September 30, 1999.  These awards are not
renewable.  Before completion of the R03, investigators are encouraged to seek
continuing support for research through a research project grant (R01).

Replacement of the Principal Investigator on this award is not permitted. FUNDS
AVAILABLE

It is estimated that $1.0 million (total costs) will be available to support
approximately 10 to 15 awards under this program.  Awards are contingent on the
availability of appropriated funds and on the receipt of sufficiently meritorious
applications meeting the stated eligibility requirements.

RESEARCH OBJECTIVES

The Small Grant program is designed to facilitate the entry of promising new
investigators into high priority areas identified by the NIAMS.  Appropriate
research areas may include, but are not limited to, the following:

o Vascular manifestations of rheumatic, connective tissue, and skin diseases

o  Studies of vasculitis and vasculopathies in animal models of rheumatic
diseases, with emphasis on identification of pathogenetic mechanisms and
molecular targets for therapeutic intervention

o  Therapeutic potential of angiogenesis inhibitors/modulators in rheumatoid
arthritis, psoriasis, immune and non-immune inflammation of the skin (including
irritant and allergic contact dermatitis), autoimmune diseases of skin, atopic
dermatitis, and wound healing

o Mechanisms of self-recognition in autoimmunity and design of therapies to
prevent abnormal responses to self by affecting antigen processing

o Mechanisms of end organ damage in rheumatic and skin disease and dissection of
the genetics of end-organ disease

o Primary and secondary analysis of data sets from arthritis and musculoskeletal
and skin disease studies (clinical trials, epidemiology or applied)

o Stem cell biology as related to skin, cartilage, bone, and muscle

o Growth and repair of connective tissues, including skin, bone, cartilage,
tendon, ligament, muscle, and the intervertebral disc

o Interactions between matrices/scaffolds and cells in the use of tissue
engineering to repair bone, connective tissues, and skin

o Mechanisms of bone, cartilage, muscle, and connective tissue responses to
mechanical loading

o Molecular mechanisms underlying the responses of muscle to physical activity

o Interactions of bone and connective tissue with materials of orthopedic
instruments, implants and prostheses, the enhancement of integration with bone,
and the development of optimal designs and materials to facilitate this tissue
biomaterial interaction

o Response of connective tissue to repetitive stresses, including healing/repair,
a better understanding of the relationship at the biological and biomechanical
interface, and the development and validation of suitable animal models

o Models and markers of gender and genetic factors in musculoskeletal injuries
and diseases, including animal models of human disease 

o Studies of regulation of cell signaling in autoreactive cells in lupus,
rheumatoid arthritis and other rheumatic diseases

o Mechanisms underlying the relationship between the female gender and increased
susceptibility to rheumatic diseases

o  Rheumatic, muscular, and dermatological manifestations of acquired
immunodeficiency syndrome

o  Pathogenesis of alopecia areata and vitiligo

o Pathogenesis, genetics, biochemistry, molecular and cellular biology of keloids

o Pathogenesis of genetic muscle diseases.

This list is intended to be illustrative and not exclusive or restrictive.  The
purpose of this RFA is to promote investigator initiated research projects on
arthritis and musculoskeletal and skin diseases.

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, unless a clear and 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
"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 in the NIH Guide for Grants and Contracts, Vol. 23, No.
11, March 18, 1994.  This information is available on the internet at
https://grants.nih.gov/grants/guide/notice-files/not94-105.html.

Investigators also may obtain copies of the policy from the program staff listed
under INQUIRIES.  Program staff may also provide additional relevant information
concerning the policy.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that children must be included in all human subjects
research conducted or supported by the NIH unless there are scientific or ethical
reasons not to include them.  The goal of the policy is to increase the
participation of children in research to obtain appropriate data.  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" which was published in the NIH
Guide for Grants and Contracts, March 6, 1998.  This information is available on
the internet at https://grants.nih.gov/grants/guide/notice-files/not98-024.html.

Investigators also may obtain copies of the policies on "Inclusion of Women and
Minorities in Research Involving Human Subjects" and "Inclusion of Children as
Participants in Research Involving Human Subjects" from the program staff listed
under INQUIRIES.  Program staff may also provide additional relevant information
concerning the policy.

APPLICATION PROCEDURES

Applications are to be submitted on grant application form PHS 398 (rev. 5/95). 
Application kits are available at most institutional offices of sponsored
research and may be obtained 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.

The following instructions are to be used in conjunction with the information
accompanying application form PHS 398 (rev. 5/95).  They refer only to selected
items in the application form.  All PHS 398 requirements must be adhered to, with
the exception of those items affected by the following instructions; for example,
the Research Plan is limited to 10 pages.  Applications not conforming to the
requested format will be returned to the applicant without review. Please note
that some of the information to be omitted from the application at submission may
be requested following review if the possibility of funding exists.

Face Page

o  Item 2, Response to Specific Program Announcement:  Check the box marked YES. 
Enter the RFA number (AR-99-001) and title (NIAMS Small Grants Program).

o  Item 6, Dates of Proposed Period of Support.  Up to a total of three years of
support may be proposed.

o  The RFA label available in the PHS 398 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.

Detailed Budget for Initial Budget Period (Page 4)

o  Do not complete or submit this page.

Budget for Entire Proposed Period of Support (Page 5)

o  Composite Budget Table:  Enter total direct costs requested, up to a maximum
of $50,000, for each year of support (up to three).

o  Justification:  Provide a narrative justification for each proposed personnel
position, including role on the project and proposed level of effort

o  Provide narrative justification for the additional resources requested for the
conduct of the project.

Biographical Sketch (Page 6) (Complete for each of the key personnel listed on
Form Page 2.)

o  Research and Professional Experience:  List current position(s) and those
previous positions directly relevant to the application.

o  List selected peer-reviewed publications directly relevant to the proposed
project, with full citations.

o  Provide information on research projects completed and/or research grants in
which the investigator participated during the last five years which are relevant
to the proposed project.  For each project or grant listed, provide title, name
of Principal Investigator, funding source, and role on project (if not Principal
Investigator).

Other Support (Page 7)
o  Do not complete or submit this section.

Research Plan

o  Items a - d of the Research Plan (Specific Aims, Background and Significance,
Preliminary Studies, and Research Design and Methods) may not exceed a total of
10 pages.  Please note that a Progress Report is not needed; no competing
continuation applications will be accepted for an R03.

Appendix

o  Appendix material may not be used to circumvent the page limitations. 
Publications may not be submitted as appendix.

Checklist

o  The Checklist should not be submitted.

Submit a signed original of the application and four 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, one additional copy of the application must 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

In order not to delay review, it is important that applicants comply with this
request.

Applications must be received by January 22, 1999.  If an application is received
after that date, it will be returned to the applicant without review.  Only one
Small Grant application may be submitted by a Principal Investigator.  Applicants
may not submit an R01 or any career award (K mechanism) application for the
October 1, 1998 or February 1, 1999 receipt date if that application involves
significant scientific overlap with a Small Grant application.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the Center for
Scientific Review (CSR).  NIAMS staff will review applications for responsiveness
to the research objectives of this RFA and for the eligibility of the Principal
Investigator under the requirements stated above.  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
committee convened by the NIAMS in accordance with the usual NIH peer review
procedures.

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 applications under
review, will be discussed, assigned a priority score, and receive a second level
review by the National Arthritis and Musculoskeletal and Skin Disease Advisory
Council.

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

The initial review group will also examine the provisions for the protection of
human and animal subjects, the safety of the research environment, and
conformance with the NIH Guidelines for the Inclusion of Women and Minorities as
Subjects in Clinical Research.

AWARD CRITERIA

The following will be considered in making funding decisions:

o  Quality of the proposed project as determined by peer review
o  Importance of the area to NIAMS research
o  Availability of funds.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions
from potential applicants is welcome.

Direct inquiries regarding programmatic issues to one of the following persons,
according to scientific area:

Dr. Susana A. Serrate-Sztein
Rheumatic Diseases
45 Center Drive, Room 5AS-37G
Bethesda, MD  20892-6500
Telephone:  (301) 594-5032
FAX:  (301) 480-4543
Email:  SzteinS@ep.niams.nih.gov

Dr. Bernadette Tyree
Cartilage and Connective Tissue
45 Center Drive, Room 5AS-37J
Bethesda, MD  20892-6500
Telephone: (301) 594-5032
FAX:  (301) 594-4543
Email:  TyreeB@ep.niams.nih.gov

Dr. Richard W. Lymn
Muscle Biology
45 Center Drive, Room 5AS-49E
Bethesda, MD  20892-6500
Telephone:  (301) 594-5128
FAX:  (301) 480-4543
Email:  LymnR@ep.niams.nih.gov

Dr. James S. Panagis
Orthopedics
45 Center Drive, Room 5AS-37K
Bethesda, MD  20892-6500
Telephone:  (301) 594-5055
FAX:  (301) 594-4543
Email:  PanagisJ@ep.niams.nih.gov

Dr. Alan N. Moshell
Skin Diseases
45 Center Drive, Room 5AS-25L
Bethesda, MD  20892-6500
Telephone:  (301) 594-5017
FAX:  (301) 480-4543
Email:  MoshellA@ep.niams.nih.gov

Dr. William J. Sharrock
Bone Biology
45 Center Drive, Room 5AS-37A
Bethesda, MD  20892-6500
Telephone:  (301) 594-5055
FAX:  (301) 480-4543
Email:  SharrocW@ep.niams.nih.gov

Dr. Joan McGowan
Bone Diseases
45 Center Drive, Room 5AS-43E
Bethesda, MD 20892-6500
Telephone:  (301) 594-5055
FAX:  (301) 480-4543
Email:  McgowanJ@ep.niams.nih.gov

Direct inquiries regarding fiscal matters to:

Sally A Nichols
Grants Management Office
National Institute of Arthritis and Musculoskeletal and Skin Diseases
45 Center Drive, Room 5AS-49F, MSC 6500
Bethesda, MD  20892-6500
Telephone:  (301) 594-3535
FAX:  (301) 480-5450
Email:  NicholsS@ep.niams.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.846.  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 and contract recipients to provide a smoke-
free workplace and promote the non-use of all tobacco products.  In addition,
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain
facilities (or in some cases, any portion of a facility) in which regular or
routine education, library, day care, health care or early childhood development
services are provided to children.  This is consistent with the PHS mission to
protect and advance the physical and mental health of the American people.

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