NIAMS SMALL GRANT PROGRAM FOR NEW INVESTIGATORS

Release Date:  May 7, 1999

PA NUMBER:  PAR-99-099

P.T.

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Application Receipt Dates:  June 22, 1999 and October 19, 1999
February 22, 2000, June 21, 2000, and October 18, 2000
February 21, 2001, June 20, 2001, and October 17, 2001

THIS PROGRAM ANNOUNCEMENT (PA) 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
PA.

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 areas of research supported by the NIAMS. 
Applications are especially encouraged from new investigators who hold a faculty
position at an HBCU (Historically Black College or University) or other
institutions that have student populations consisting predominantly of
individuals from racial or ethnic groups that are underrepresented in science. 
This solicitation will provide support for pilot research that is likely to lead
to a subsequent individual research project grant (R01).

This is a change in our previous policy of one application receipt date each
fiscal year for the small grant mechanism.  As noted, for calendar year 1999,
there will be two application receipt dates, with three receipt dates in 2000 and
2001.

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 Program Announcement (PA), 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 serving institutions is strongly encouraged.  Pilot
project grants awarded through this PA 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

This PA will use the National Institutes of Health (NIH) small grant (R03)
mechanism of support.  Applicants may request up to $50,000 (direct costs) per
year for up to three years.  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.

To comply with Grants Policy changes effective June 1, 1999, specific application
instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME"
streamlining efforts.  The modular grant concept establishes specific modules in
which direct costs may be requested under this approach.  The just-in-time
concept allows applicants to submit certain information only when there is a
possibility for an award.  It is anticipated that these changes will reduce the
administrative burden for the applicants, reviewers and institute staff. 
Complete and detailed instructions and information on Modular Grants can be found
at http://www.nih.gov/grants/funding/modular/modular.htm .

Applications will request direct costs in $25,000 modules, up to a total direct
cost request of $50,000 per year.  A typical modular grant application will
request the same number of modules in each year.

Application budgets will be simplified.  Detailed categorical budget information
will not be submitted with the application; budget form pages of the application
kits will not be used.  Instead, total direct costs requested for each year will
be presented.  Information, in narrative form, will be provided only for
Personnel and, when applicable, for Consortium/Contractual Costs.  See section
on application instructions below.

Additional narrative budget justification will be required in the application
only if there is a variation in the number of modules requested.

There will be no routine escalation for future years.

Other Support pages of the PHS 398 will not be submitted with the application.

Information on research projects ongoing or completed during the last three years
by the principal investigator and key personnel will be provided as part of the
"Biographical Sketch".  This information will include the specific aims, overall
goals and responsibilities and should include Federal and non-Federal support. 
This information will be used by reviewers in the assessment of each individual's
qualifications for a specific role in the proposed project.

Following peer review, information about Other Research Support will be requested
by NIH from the applicant for applications being considered for award.

Additional budget information will be requested only under special circumstances.

FUNDS AVAILABLE

It is anticipated that for FY2000 and FY2001, approximately $1.0 million (total
costs) will be available for the first year of support for this initiative.  It
is anticipated that up to 10 to 15 new grants will be awarded each FY 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 NIAMS Small Grant program is designed to facilitate the entry of promising
new investigators into areas of research supported 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 PA is to promote investigator initiated research projects on
arthritis and musculoskeletal and skin diseases and injuries.

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 new
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, 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.

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 http://www.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 the research grant application form PHS 398
(rev. 4/98), with the modifications noted below.  For this program announcement,
application receipt dates are June 22, 1999, October 19, 1999, February 22, 2000,
June 21, 2000, October 18, 2000, February 21, 2001, June 20, 2001 and October 17,
2001.  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;
and on the internet at http://www.nih.gov/grants/funding/phs398/phs398.html.

The PA title, NIAMS Small Grant Program for New Investigators, and number (PAR-
99-099) must be typed on line 2 of the face page of the application form and the
YES box must be checked.

BUDGET INSTRUCTIONS

The total direct costs must be requested in accordance with the program
guidelines and the modifications made to the standard PHS 398 application
instructions described below:

PHS 398

o  FACE PAGE - Items 7a and 7b should be completed, indicating Direct Costs (in
$25,000 increments up to a maximum of $50,000) 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 http://www.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:\
http://www.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 in 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.

o  The applicant should provide the name and phone number of the individual to
contact concerning fiscal and administrative issues if additional information is
necessary following the initial review.

o  Description of the Research Plan is limited to 10 pages.

APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED UNRESPONSIVE
TO THIS PA AND WILL BE RETURNED WITHOUT FURTHER CONSIDERATION.

Submit a signed typewritten original of the application and three signed
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/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 received after any of the receipt dates listed above will be
deferred to the next review cycle.  A Prinicipal Investigator may submit only one
Small Grant application to the NIAMS in any review cycle.  Applicants may not
submit an application for the same review cycle in which a Small Grant is
submitted, if that application involves significant scientific overlap with the
Small Grant application.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR.  Incomplete
applications will be returned to the applicant without further consideration. 
NIAMS staff will review applications for responsiveness to the research
objectives of this PA and for the eligibility of the Principal Investigator under
the requirements stated above.  Applications found to be unresponsive or
ineligible will be returned without further consideration.  Applications that are
complete and responsive to the PA 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.

Review Criteria

Review criteria and major factors to be considered in the evaluation of the
applications will include:

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 review, comments on the following aspects of the application will be made
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 the assignment of the overall score.

(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 investigator 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?

As part of the scientific and technical merit evaluation of the research plan,
reviewers will be instructed to address the adequacy of plans to include both
genders and minorities and their subgroups, and children as appropriate for the
scientific goals of the research, or justification for exclusion. will be
reviewed.  If applicable, plans for the recruitment and retention of subjects
will also be evaluated.

The personnel category will be reviewed for appropriate staffing based on the
requested percent effort.  The direct costs budget request will be reviewed for
consistency with the proposed methods and specific aims.  Any budgetary
adjustments recommended by the reviewers will be in $25,000 modules.  The
duration of support will be reviewed to determine if it is appropriate to ensure
successful completion of the requested scope of the project.

AWARD CRITERIA

The following will be considered in making funding decisions:

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

INQUIRIES

Inquiries concerning this PA are encouraged.  Additional information, including
sample budget narratives and biographical sketch, may be found at:
http://www.nih.gov/grants/funding/modular/modular.htm.  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:

Orthopedics and Bioengineering

Dr. James S. Panagis
45 Center Drive, Room 5AS-37K
Bethesda, MD  20892-6500
Telephone:  (301) 594-5055
FAX:  (301) 594-4543
Email:  jp149d@nih.gov

Rheumatic Diseases

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

Cartilage and Connective Tissue

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

Muscle Biology

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

Skin Diseases

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

Bone Biology

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

Bone Diseases

Dr. Joan McGowan
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 Officer
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 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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