HIGH RISK ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES RESEARCH

Release Date:  January 10, 2001

RFA:  RFA-AR-01-004

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Letter of Intent Receipt Date:  February 15, 2001
Application Receipt Date:       March 26, 2001

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 purpose of this initiative is to broaden the base of inquiry in 
fundamental biomedical, biobehavioral, and biomedical technology research by 
encouraging applications for research projects that involve an especially 
high degree of innovation and novelty and, therefore, require a preliminary 
test of feasibility.  The research projects proposed under this Request for 
Applications (RFA) may involve substantial experimental risks such that their 
potential for highly significant outcomes may be difficult to judge by the 
standard criteria used in evaluating investigator initiated (R01) proposals. 
Preliminary data are not required.  The work proposed may not overlap with 
the aims of currently supported projects in which the Principal Investigator 
has participated during the last five years.  Proposed projects must support 
the mission of the National Institute of Arthritis and Musculoskeletal and 
Skin Diseases (NIAMS).

Two kinds of experienced investigators are sought.  First, established 
investigators in arthritis or musculoskeletal or skin diseases are encouraged 
to present a proposal for testing the feasibility of a novel idea, resource 
or technology.  The project should represent a clear and distinct departure 
from the investigator's ongoing research.  Second, established investigators 
with no previous work in arthritis or musculoskeletal or skin diseases are 
encouraged to apply their expertise to research relevant to arthritis or 
musculoskeletal or skin diseases.

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 RFA, High Risk 
Arthritis and Musculoskeletal and Skin Diseases Research, is related to the 
priority area of chronic diseases.  Potential applicants may obtain a copy of 
"Healthy People 2010" at http://www.health.gov/healthypeople/.


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.

The proposed work must be new and not overlap with projects in which the 
Principal Investigator has participated during the last five years.  Projects 
that could reasonably be considered a logical  and immediate extension of 
current work are not within the scope of this RFA. (Information on such 
projects is to be provided as part of the Principal Investigator's 
Biographical Sketch, as described below under Application Procedures.)  
Applications will be programmatically reviewed by NIAMS staff for eligibility 
before they are formally accepted.  Investigators who have questions about 
eligibility should contact one of the program officials listed under 
INQUIRIES.

MECHANISM OF SUPPORT

Research projects will be supported with the exploratory/developmental 
research grant (R21).  Applicants may request up to $50,000 (direct costs) 
per year for up to two years.  These awards are not renewable.  If desired, 
the specific aims of the R21 project may be incorporated into a research 
project grant application (R01) submitted prior to the termination of the R21 
award. This RFA is a one-time solicitation.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" streamlining efforts.  Complete and detailed 
instructions and information on Modular Grants can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

FUNDS AVAILABLE

It is anticipated that for FY 2001, approximately $1,000,000 total costs will 
be available for the first year of support for this initiative.  Award of 
grants is contingent upon the receipt of such funds for this purpose.  It is 
anticipated that up to 12 new grants will be awarded under this program.  The 
specific number to be funded will depend on the merit and scope of the 
applications received and on the availability of funds.  Direct costs will be 
awarded in modules of $25,000, less any overlap or other necessary 
administrative adjustments.  Facilities and Administrative costs will be 
awarded based on the negotiated rates.  Applicants may request up to two 
years of support.

RESEARCH OBJECTIVES

The NIAMS seeks to broaden the base of inquiry in fundamental biomedical, 
biobehavioral, and biomedical technology research by encouraging research 
projects that involve a high degree of innovation and novelty.  Because 
innovative projects may require a preliminary test of feasibility, this 
initiative will provide short-term support for such preliminary work.  Each 
research plan should begin with a short paragraph describing how the proposed 
project represents a high degree of innovation and novelty that does not 
overlap with recently funded research. The projects must support the NIAMS 
mission as detailed in the NIAMS World Wide Web home page, which can be found 
at http://www.nih.gov/niams/about/ep1.htm.  In brief, the NIAMS supports 
research in:  a) rheumatic diseases; b) cartilage biology and diseases; c) 
bone biology and diseases (e.g., osteoporosis, Paget's disease); d) skin 
biology and skin diseases; e) autoimmune diseases (e.g., lupus); f) 
connective tissue diseases; g) musculoskeletal diseases, injuries and 
disorders; h) muscle biology and diseases (e.g., muscular dystrophy); 
exercise physiology and musculoskeletal fitness; i) sports injuries; j) 
occupational diseases and injuries; and k) orthopaedics and bioengineering.

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 and 
compelling rationale and justification are provided indicating 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," published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); a 
complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: 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 to 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 the 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 or 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: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

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

LETTER OF INTENT

Prospective applicants are asked to submit, by February 15, 2001, a letter of 
intent that includes a descriptive 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 this RFA. Although a 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 a subsequent application, 
the information that it contains allows IC staff to estimate the potential 
review workload and to plan the review. The letter of intent is to be sent 
(e-mail, fax or post) to Dr. Tommy Broadwater at the address listed under 
INQUIRIES.

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.

APPLICATION PROCEDURES

The research grant application form PHS 398 (rev. 4/98) is to be used in 
applying for these grants, with the modifications noted below.  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 301/435-0714, Email: ; and on the internet 
at http://grants.nih.gov/grants/funding/phs398/phs398.html

The RFA label found in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  The RFA label and 
line 2 of the application should both indicate the RFA number.  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, High Risk Arthritis and Musculoskeletal and Skin Diseases 
Research, and number, AR-01-004, must be typed on line 2 of the face page of 
the application form and the YES box must be marked.

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.
BUDGET INSTRUCTIONS

Modular grant 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.

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://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 all 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 all 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. 
Include the letter of intent to establish a consortium.

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 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://grants.nih.gov/grants/funding/modular/modular.htm.

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

o  RESEARCH PLAN - The research plan (a-d) is limited to 10 pages. The 
Background and Significance Section of the application should specifically 
state how the project represents a new direction for the work performed at 
the PI’s laboratory.  The Preliminary Data section is not required. If 
included in R21 applications, it must not exceed 1 page. Applications that 
exceed the page limit will be returned without review. An appendix may be 
included in the application; however, the appendix is not to be used to 
circumvent the page limit of the research plan. 

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.  All appropriate exclusions must be applied 
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.


APPLICATIONS NOT CONFORMING TO THESE GUIDELINES WILL BE CONSIDERED 
UNRESPONSIVE TO THIS RFA 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, two additional copies 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 March 26, 2001.  If an application is 
received after that date, it will be returned to the applicant without 
review. Only one R21 grant application may be submitted by a Principal 
Investigator.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and 
responsiveness by NIAMS.  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 NIAMS 
in accordance with the review criteria stated below.  As part of the initial 
merit review, all applications will receive a written critique and under 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 NIAMS 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.  For 
this initiative, the proposed project must have the potential for developing 
ground-breaking technology or methodology that may lead to significant 
expansion of biomedical research horizons, precipitate a paradigm shift in 
research, or lead to substantial improvements in human 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 the proposed study clearly not overlap with recently 
funded research? 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 
methods? 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?

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. 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.

SCHEDULE

Letter of Intent Date:     February 15, 2001
Application Receipt Date:  March 26, 2001
Peer Review Date:          TBA (June/July 2001)
Council Review:            September 24, 2001
Start Date:                September 30, 2001

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
o  Potential for ground-breaking, precedent setting significance of the 
proposed research, with particular emphasis on novel and innovative 
approaches that clearly require additional preliminary data for their value 
to be established.

INQUIRIES

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 one of the following 
persons, according to scientific area:

Cartilage and Connective Tissue

Dr. Bernadette Tyree
45 Center Drive, Room 5AS-37J
Bethesda, MD  20892-6500
Telephone: (301) 594-5032
FAX:  (301) 480-4543
Email:  bt16w@nih.gov

Rheumatic Diseases

Dr. Elizabeth Gretz
45 Center Drive, Room 5AS-19J
Bethesda, MD 20892-6500
Telephone: (301) 594-5032
FAX: (301 480-4543
Email: gretze@mail.nih.gov

Dr. Susana A. Serrate-Sztein
45 Center Drive, Room 5AS-37G
Bethesda, MD  20892-6500
Telephone:  (301) 594-5032
FAX:  (301) 480-4543
Email:  ss86e@nih.gov

Behavioral and Prevention Research

Dr. Deborah N. Ader
45 Center Dr., Room 5AS19H
Bethesda, MD  20892-6500
Telephone:  (301) 594-5032
FAX:  (301) 480-4543
Email:  aderd@mail.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:  rl28b@nih.gov

Orthopaedics

Dr. James S. Panagis
45 Center Drive, Room 5AS-37K
Bethesda, MD  20892-6500
Telephone:  (301) 594-5055
FAX:  (301) 480-4543
Email:  jp149d@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: am40j@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:  ws19h@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:  jm106v@nih.gov

Direct inquiries regarding fiscal matters to:

Melinda Nelson
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: nelsonm@mail.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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