CORE CENTERS FOR MUSCULOSKELETAL DISORDERS

NIH Guide, Volume 26, Number 39, December 5, 1997

RFA:  AR-98-004

P.T.

National Institute of Arthritis and Musculoskeletal and Skin Diseases

Letter of Intent Receipt Date:  May 15, 1998
Application Receipt Date:  July 15, 1998

PURPOSE

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
invites applications for research core centers (P30s) in musculoskeletal
disorders.  The Core Centers for Musculoskeletal Disorders (CCMDs) will provide
the resources for a number of established, currently funded investigators, often
from different disciplines, to adopt a multidisciplinary approach to common
research problems in musculoskeletal disorders and to ensure greater productivity
than from each of the separate 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 Request for Applications (RFA), Core
Center for Musculoskeletal Disorders, is related to the priority area of chronic
disabling conditions.  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 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.  An established clinical and basic research program in
musculoskeletal disorders must be present.  Applications from racial/ethnic
minority individuals and women and persons with disabilities are encouraged.

MECHANISM OF SUPPORT

This RFA will use the NIH Core Center Grant (P30).  Responsibility for the
planning, direction, and execution of the proposed project will be solely that
of the applicant.  Investigators are to  request five years of support.  The
anticipated award date is April 1, 1999.

FUNDS AVAILABLE

The direct costs requested cannot exceed $400,000 each year.  The NIAMS intends
to fund up to two  P30 applications responding to this RFA in FY 1999, subject
to the availability of resources and receipt of sufficiently meritorious
applications.  The estimated funds (total costs) available for the first year of
support of these centers are $1.2 million.

RESEARCH OBJECTIVES

Research in musculoskeletal disorders is at a stage where a number of areas are
making broad advances that can be effectively fostered by research core centers. 
Examples of these areas include, but are not limited to:

o  Regulation of skeletal growth and remodeling by systemic and local factors;
diagnostic markers of skeletal remodeling; genetic basis of skeletal
morphogenesis, growth, and disease.

o  Mechanisms of bone repair and regeneration, including fracture healing;
development of techniques for growth plate repair, reconstitution of large
defects, and limb lengthening, including use of autografts and allografts, and
distraction osteogenesis.

o  Mechanisms of cartilage repair and regeneration, including chondroprogenitor
cell biology, genetics, and biomechanical signalling; development of techniques
for chondroprotection and repair of the articular surface, including gene therapy
approaches.

The choice of research area upon which the CCMD would focus is made by the
principal and collaborating currently funded investigators.

The CCMDs will provide support for:

1.  Core resources and facilities to be used by investigators of individually
supported research projects in order to enhance and coordinate their activities. 
This support may include personnel, equipment, supplies, services, and
facilities.

2.  Up to $100,000 yearly in direct costs for pilot and feasibility studies.

3.  Program enrichment activities.

4.  Administrative Core

A CCMD should be an identifiable organizational unit within a university-
affiliated medical center.  An Administrative Core should be proposed to
coordinate the Center and administer the program enrichment activities.  Two or
more research cores must be proposed.  A research core is a facility shared by
two or more Center investigators that enables them to conduct their independently
funded individual research projects more efficiently and/or more effectively. 
Cores generally fall into one of four categories:  (1) provision of a technology
that lends itself to automation or preparation in large batches (e.g., histology
and tissue culture); (2) complex instrumentation (e.g., electron microscopy); (3)
animal preparation and care; and (4) service and training (e.g., molecular
biology, biostatistics).

A pilot and feasibility study program provides modest research support ($20,000 -
 $50,000 yearly) for a limited time (1 to 3 years) to enable eligible
investigators to explore the feasibility of a musculoskeletal disorders-related
concept and amass sufficient data to pursue it through other funding mechanisms. 
An investigator is eligible only once every 5 years.  Eligible investigators
include

1.  an established investigator in musculoskeletal disorders or related areas
with a proposal for testing the feasibility of a new or innovative idea that is
musculoskeletal disorders-related but represents a clear and distinct departure
from the investigator's ongoing research interest;

2.  an established, supported investigator with no previous work in
musculoskeletal disorders or related areas who is willing to test the
applicability of his/her expertise on a musculoskeletal disorders-related
problem; and

3.  a new investigator who has not been a principal investigator in a past or
current NIH research project grant (R01, R29, P01) or a current R55 grant.  New
investigators should be clearly independent and have a faculty appointment higher
than that of postdoctoral fellow or research associate.

Applicants from institutions which 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.  Details of the
interactions of the CCMD staff with the GCRC staff and research personnel may be
provided in a statement describing the collaborative linkages being developed. 
A letter of agreement from the GCRC Program Director must be included with the
application.

SPECIAL REQUIREMENTS

The director and co-director should budget for an annual one-day meeting in
Bethesda, MD with NIAMS staff.

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 is 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,
Volume 23, Number 11, March 18, 1994.

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.

LETTER OF INTENT

Prospective applicants are asked to submit, by May 15, 1998, 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 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 NIAMS staff to estimate the
potential review workload and to avoid conflict of interest in the selection of
reviewers.  The letter of intent is to be sent to Dr. Julia B. Freeman at the
address listed under INQUIRIES.

APPLICATION PROCEDURES

Special guidelines have been developed for Core Centers supported by NIAMS. 
These guidelines should be used in assembling the application. See INQUIRIES for
obtaining a copy of these guidelines.

The research grant application form PHS 398 (rev. 5/95) is to be used in applying
for these grants.  Applications 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:
ASKNIH@od.nih.gov.

The RFA label available in the PHS 398 (rev. 5/95) 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, "Core
Center for Musculoskeletal Disorders", and number, "AR-98-004" must be typed on
line 2 of the face page of the application form and the YES box must be marked.

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

CENTER FOR SCIENTIFIC REVIEW (formerly Division of Research Grants)
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, send two additional copies of the application to:

Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Natcher Building, Room 5AS.25U - MSC 6500
Bethesda, MD  20892-6500
Bethesda, MD  20814 (for express/courier service)

Applications must be received by July 15, 1998.  If an application is received
after that date, it will be returned to the applicant without review.

REVIEW CONSIDERATIONS

Applications for Core Center grants will first be screened for completeness by
the Center for Scientific Review (formerly DRG) and for responsiveness by NIAMS
staff.  Applications that are complete and responsive may be subjected to a
preliminary evaluation by a peer review group to determine their scientific merit
relative to the other applications received in response to this RFA; the NIH will
withdraw from further consideration applications judged to be noncompetitive and
promptly notify the principal investigator and the official signing for the
applicant organization.

Those applications judged to be competitive will be further evaluated for
scientific merit by a group of expert consultants convened by the Review Branch
of the NIAMS.  Each proposal should be complete in itself.  Revisions will not
be accepted after the receipt date.  Site visits are not anticipated.  It is
strongly recommended that, if appropriate,  Institutional Review Board (IRB) and
Institutional Animal Care and Use committee (IACUC) approval be secured before
the application is submitted.  Otherwise, it is the applicant's responsibility
to ensure these certifications are sent to the NIAMS Review Branch within 60 days
of the receipt date.  Applications failing to comply with this requirement will
be returned without review.  A second level of review will be performed by the
National Arthritis and Musculoskeletal and Skin Diseases Advisory Council.

Review criteria

Applicants should clearly demonstrate the ways in which the CCMD will build the
local research program, will support on-going projects and will attract both
senior and new investigators to musculoskeletal disorders research.  Review
criteria which will be used by the initial review group (IRG) in the evaluation
of the Core Center applications follow:

1.  Evaluation of Cores

A research core is evaluated on the facilities and or services provided. 
Important factors include:

Significance:  Will the core have utility to the Core Center research base
(minimum:  two independently funded investigators)?

Approach:  Are the quality of services high?  Are there procedures for quality
control?  Is the core cost effective?  How is cost reimbursement proposed?

Innovation: Will the core likely promote interdisciplinary research?  Are unique
services offered?

Investigator:  Are the personnel appropriate?

Environment:  Are the facilities and equipment adequate?  Is there institutional
commitment to the core?

2.  Evaluation of Pilot and Feasibility Studies (P&Fs)

For individual P&Fs:

Significance:  Will the proposed work likely yield meaningful preliminary data
leading to a research proposal?

Approach:  Are the experimental approaches adequate?

Innovation: Is the research topic one that promotes innovative new research
related to the core center?

Investigator:  Does the investigator meet one of the criteria for P&F
investigators?  (If not, the project should not be considered further.)

Environment: Is the project appropriate to the research base of the core center? 
Does one or more of the cores offer needed materials/assistance?

3.  Evaluation of the Administrative Core

The Administrative Core is evaluated on the leadership provided.  Important
factors include:

Significance:  Does the proposed Core Center document coordination of ongoing
research between the separately funded projects and the Core Center including
mechanisms for internal monitoring?

Approach:  Is the management proposed appropriate for 1) fiscal administration,
procurement, property and personnel management, planning, budgeting, etc.; 2)
reviewing the use of, and administering funds for, the pilot and feasibility
program?  Are the Core Center budgets appropriate for the proposed and approved
work to be done in core facilities, for pilot and feasibility studies, and for
enrichment in relation to the total Core Center program?

Innovation:  Is there a plan for the establishment and maintenance of internal
communication and cooperation among the Core Center investigators and for an
enrichment program that provides outside review and input?

Investigators:  Is there scientific and administrative leadership, commitment and
ability, and adequate time commitment of the Core Center Director and Associate
Director for the effective management of the Core Center program?

Environment:  Have institutional lines of authority and sanction been documented
for the Core Center?

4. Overall Core Center Evaluation

An overall priority score will be assigned to the application.  This score will
reflect not only the quality of the cores, administration, and pilot and
feasibility studies, but also the quality of the research base and how the
proposed Core Center will enhance the research base.

The following elements will be evaluated:

a.  The scientific excellence of the Core Center's research base as well as the
relevance and interrelation of these separately funded research projects to the
central themes of the Core Center and the likelihood for meaningful collaboration
among Core Center investigators.  Existence of a base of established
independently supported biomedical research of high quality is a prerequisite for
establishment of a Core Center.

b. The application must convey how the proposed Core Center will enhance
significantly the cited research base established at the host institution.  This
includes the qualifications, experience, and commitment of the Core Center
investigators and their willingness to interact with each other.  This also
includes efficient and effective use and/or planned use of enrichment funds
including the contribution of these activities in enhancing the realization of
the Core Center concept.

c.  The appropriateness, quality and relevance of the proposed cores, and the
modes of operation, facilities, and potential for contribution to ongoing
research.

d.  The proposed management of the pilot and feasibility program and the
scientific merit of the pilot and feasibility projects for which funds are
requested from the Core Center grant.  The effectiveness of the proposed program
will serve as a basis for recommendations concerning the level at which pilot and
feasibility studies will be supported throughout the project period.

e.  The overall environment for a Core Center.  This includes the institutional
commitment to the program, including lines of accountability regarding management
of the Core Center, and the institution's partnership with the Core Center, and
the institutional commitment to individuals responsible for conducting essential
Core Center functions. This also includes the academic environment and resources
in which the activities will be conducted, including the availability of space,
equipment, facilities, and the potential for interaction with scientists from
other departments and schools.

Since the NIAMS is interested in funding only the best research, individual
components of lesser quality may not be funded, even if approved, under the
"umbrella" of the Core Center grant mechanism.  It is primarily for this reason
that each component will be assigned a separate merit rating, taking into
consideration only its merit as an individual pilot and feasibility study or
core.

AWARD CRITERIA

The anticipated date of award is April 1999.  The primary factors determining the
award will be the priority score and the availability of funds.  Since the NIAMS
is interested in funding only the best research, individual pilot and feasibility
projects or cores of lesser quality may not be funded, even if approved, under
the "umbrella" of the CCMD mechanism.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions
from potential applicants is welcome.  Inquiries regarding programmatic issues
and letters of intent may be directed to:

Dr. Julia B. Freeman
Centers Program, EP
National Institute of Arthritis and Musculoskeletal and Skin Diseases  Natcher
Building, Room 5AS.19F -  MSC 6500
Bethesda, MD  20892-6500
Bethesda, MD  20814 (for express/courier service)
Telephone:  (301) 594-5052
FAX:  (301) 480-4543
Email:  Julia_B_Freeman@nih.gov

Copies of the guidelines for the NIAMS CORE CENTER program may be obtained from:

NIAMS Clearinghouse
1 AMS Circle
Bethesda, MD  20892-3675
Telephone: (301) 495-4484
FAX: (301) 587-4352

Guidelines are also available on the internet:

http://www.nih.gov/niams/grants/ep7.htm

Direct inquiries regarding fiscal matters to:

Sally A. Nichols
Grants Management Officer
National Institute of Arthritis and Musculoskeletal and Skin Diseases  Natcher
Building Room 5AS.49F - MSC 6500
Bethesda, MD  20892-6500
Telephone: (301) 594-3535
FAX: (301) 480-5450
Email:  nicholss@exchange.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No.
93.846, Arthritis, Musculoskeletal and Skin Diseases Research.  Awards will be
made under the authority of the Public Health Service Act, Title III, Section 301
(Public Law 410, 78th Congress, as amended, 42 USC 241) and administered under
PHS grant policies and Federal regulations 42 CFR Part 52 and 45 CFR Part 74. 
This program is not subject to 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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