SPECIALIZED CENTERS OF RESEARCH (SCORs) IN OSTEOPOROSIS, RHEUMATOID
ARTHRITIS AND SCLERODERMA
 
Release Date:  November 18, 1999

RFA:  AR-00-002

National Institute of Arthritis and Musculoskeletal and Skin Diseases
 
Letter of Intent Receipt Date:  September 18, 2000
Application Receipt Date:  October 12, 2000
 
PURPOSE
 
The National Institute of Arthritis and Musculoskeletal and Skin Diseases 
(NIAMS) invites applications for Specialized Centers of Research (SCORs) in 
the following disease areas: osteoporosis, rheumatoid arthritis, and 
scleroderma.  A SCOR should foster a coordinated research effort that 
strongly emphasizes basic disciplines, but also involves significant 
interaction between basic research and clinical investigations.  A SCOR is 
envisioned as a national resource associated with one or more major medical 
complexes and dedicated to working with the NIAMS in furthering the research 
effort to translate basic research to clinical application.  
 
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) for Specialized Centers of Research is related to the 
priority area of chronic disabling conditions.  Potential applicants may 
obtain a copy of "Healthy People 2000" at 
http://odphp.osophs.dhhs.gov/pubs/hp2000
 
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 research program in the 
disease area should be present.  Foreign organizations are not eligible. 
International collaborations in domestic applications will only be accepted 
if the resources are clearly shown to be unavailable in the United States.  
Applications from racial/ethnic minority individuals and women and persons 
with disabilities are encouraged.
 
MECHANISM OF SUPPORT
 
Support of this program will be through the NIH specialized center (P50) 
award.  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 July 1, 2001.
 
FUNDS AVAILABLE
 
The direct costs requested cannot exceed $750,000 each year (exclusive of 
facilities and administrative costs of subcontracts with collaborating 
organizations).  The NIAMS intends to fund up to 3 new and/or competing 
continuation applications responding to this RFA in FY 2001 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 $3.4 million.  						
					
 
RESEARCH OBJECTIVES
 
The objective of the SCOR program is to expedite development and application 
of new knowledge to human diseases, to learn more about the etiology of these 
diseases, and to foster improved approaches to treatment and/or prevention.  
A SCOR consists of at least three individual, but interrelated, research 
projects, each with high scientific merit and clear research objectives and, 
in the aggregate, devoted to a specific major health area.  Each SCOR should 
provide a multidisciplinary approach utilizing both laboratory and clinical 
research to focus on a particular health problem and provide for a mutually 
supportive interaction between basic scientists and clinical investigators.  
 
Clinical research  is defined as patient oriented clinical research conducted 
with human subjects, or on material of human origin (such as tissue specimens 
and cognitive phenomena) for which an investigator or colleague directly 
interacts with human subjects in an outpatient or inpatient setting to 
clarify a problem in human physiology, pathophysiology, or disease.
 
Although research programs will vary among institutions according to local 
expertise, interests, and resources, each SCOR should have a central theme 
related to the disease area to which individual projects relate and which 
serves as an integrating force.  Emphasis in proposed projects should be on 
development of innovative approaches, elaboration of new and significant 
hypotheses, and generation of improved strategies for approaching current 
issues relating to the disease area addressed.  Collaboration among 
institutions is encouraged within a given SCOR to share scarce patient 
resources.
 
Funding may also be requested for one or more core resources.  A core is 
defined as a resource shared by multiple investigators that enhances research 
productivity and increases the functional capacity of the SCOR.  Ongoing 
projects may be absorbed into the SCOR if their original funding source is 
relinquished.
 
Support for large clinical trials or for applications that contain 
exclusively clinical or exclusively basic studies will not be provided within 
this SCOR program.
 
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 SCOR 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.  The director should be prepared to devote at 
least 15 percent effort as the director and 20 percent effort as a project 
PI.  Each project and core PI should be prepared to devote at least 20 
percent effort.
 
To be funded, a SCOR must include at least three highly meritorious projects 
approved for five years.  One of these must have the SCOR director as the 
principal investigator, and the highly meritorious projects must include both 
basic and clinical research.
 
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 was 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, available on the web at:  
http://grants.nih.gov/grants/guide/notice-files/not94-100.html 
 
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS 

It is the policy of 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 and 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 September 18, 2000, 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 by NIAMS for the SCOR program.  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. 4/98) 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 301/435-0714, email: grantsinfo@nih.gov  and on the 
internet at http://grants.nih.gov/grants/forms.htm

The RFA label available 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, "Specialized Centers of Research" and number, "AR-00-002" 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.

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 
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 October 12, 2000.  If an application is 
received after that date, it will be returned to the applicant without 
review.  
 
REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by the Center 
for Scientific Review (CSR) and responsiveness by the NIAMS.  Incomplete 
and/or non-responsive applications will be returned to applicant without 
further consideration.  Applications that are complete and responsive to the 
RFA will be evaluated for scientific and technical merit by a peer review 
group convened by the NIAMS in accordance with the review criteria stated 
below.  As part of the initial merit review, a process will be used by the 
initial review group in which applications 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 the applications under review, 
will be discussed, assigned a priority score, and receive a second level of 
review by the National Arthritis and Musculoskeletal and Skin Diseases 
Advisory Council.

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.
 
If the project from the SCOR director is not recommended for further 
consideration during the review for scientific merit, the entire SCOR 
application will not be reviewed further.  If all the clinical research 
projects in a SCOR application are not recommended for further consideration, 
the SCOR application will not be further reviewed.
 
Major factors to be considered in evaluation of applications will include:
 
1.	How the proposed SCOR combines basic and clinical research into the 
scientific goals and research theme;

2. 	If a competing continuation application, the quality and significance of 
the progress made in the previous funding period;

3.	Scientific merit of each proposed project. [Each project will receive a 
priority score. This score reflects not only the feasibility of the 
project and adequacy of the experimental design, but also the design of 
the project to advance both the theme of the SCOR and the interaction 
between basic research and clinical investigation.]; 
4.	Scientific merit of combining the component parts into a SCOR;

5.	Technical merit and justification of each core unit;

6.	Competence of the investigators to accomplish the proposed research 
goals, their commitment, and the time they will devote to the research 
program;

7.	Adequacy of facilities to perform the proposed research, including 
laboratory and clinical facilities, instrumentation, and data management 
systems, when needed;

8.	Adequacy of plans for interaction among investigators, and the 
integration of the various projects and core units;

9.	Qualifications, experience and commitment of the SCOR Director and 
his/her ability to devote time and effort to provide effective 
leadership;

10.	Scientific and administrative structure, including internal and external 
procedures for monitoring and evaluating the proposed research and for 
providing ongoing quality control and scientific review;

11.	Institutional commitment to the program, and the appropriateness of 
resources and policies for the administration of a SCOR;

12.	Adequacy of plans to include both genders and minorities and their 
subgroups and children as appropriate for the scientific goals of the 
research.  Plans for the recruitment and retention of subjects will also 
be evaluated.
 
The appropriateness of the budget for the proposed program and its individual 
components will be considered independently of the factors indicated above.
 
AWARD CRITERIA
 
The anticipated award date is July 1, 2001. The primary factors determining 
the award will be the priority score, the overall balance of meritorious 
projects (clinical and basic research) within the application relative to the 
disease area, and the availability of funds.  Since the NIAMS is interested 
in funding only the best research, individual projects or cores of lesser 
quality may not be funded, even if approved, under the "umbrella" of the SCOR 
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 SCOR 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 Parts 52 
and 45 CFR Parts 74 and 92.  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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