SKIN DISEASES RESEARCH CORE CENTERS
 
RELEASE DATE:  November 21, 2002 (see reissue RFA-AR-05-002)
 
RFA:  AR-03-003
 
National Institute of Arthritis and Musculoskeletal and Skin Diseases 
(NIAMS)
 (http://www.niams.nih.gov)
 
LETTER OF INTENT RECEIPT DATE:  April 13, 2003

APPLICATION RECEIPT DATE:  May 13, 2003
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements 
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:

PURPOSE OF THIS RFA

The National Institute of Arthritis and Musculoskeletal and Skin 
Diseases (NIAMS) invites applications for research core centers (P30s) 
in skin diseases.  The Skin Diseases Research Core Centers (SDRCs) 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 skin diseases 
and to ensure greater productivity than from each of the separate 
projects.

RESEARCH OBJECTIVES

Research in skin diseases 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   stratum corneum: biochemistry, structure, function
o   epidermis: differentiation, keratinization, cellular constituents
o   dermal-epidermal junction: structure, functions, diseases
o   skin as an immunological organ
o   autoimmune skin diseases
o   dermis: structural components, diseases
o   molecular genetics and epidemiology of skin diseases

The choice of research area upon which the SDRC would focus is made by 
the principal investigator and collaborating currently funded 
investigators.  However, research focused on advanced skin cancers, 
including metastasis and treatment, is not in the NIAMS research 
mission and should not be the research basis of an SDRC.  Any questions 
with regard to cancer relatedness should be directed for clarification 
to the Centers Program Director.

The SDRCs 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 SDRC 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 skin diseases-
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 skin diseases or related areas with 
a proposal for testing the feasibility of a new or innovative idea that 
is skin diseases-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 
skin diseases or related areas who is willing to test the applicability 
of his/her expertise on a skin diseases-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 that 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 SDRC 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.

MECHANISM OF SUPPORT
 
This RFA will use NIH P30 award mechanism.  As an applicant you will be 
solely responsible for planning, directing, and executing the proposed 
project.  This RFA is a one-time solicitation.  Future competing-
continuation applications based on this project will be the subject of 
a future RFA.  The anticipated award date is April 1, 2004.

This RFA uses just-in-time concepts.  

FUNDS AVAILABLE 
 
NIAMS intends to commit approximately $2.4 million in FY 2004 to fund 
up to 4 new and/or competing-continuation grants in response to this 
RFA. An applicant should request a project period of 5 years and a 
budget for direct costs of up to $400,000 per year. Although the 
financial plans of the NIAMS provide support for this program, awards 
pursuant to this RFA are contingent upon the availability of funds and 
the receipt of a sufficient number of meritorious applications.
 
ELIGIBLE INSTITUTIONS
 
You may submit (an) application(s) if your institution has any of the 
following characteristics:

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories
o Faith-based or community-based organizations.

Applications from foreign institutions will not be accepted.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with their 
institution to develop an application for support.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.   

SPECIAL REQUIREMENTS 

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

We encourage inquiries concerning this RFA and welcome the opportunity 
to answer questions from potential applicants.  Inquiries may fall into 
three areas:  scientific/research, peer review, and financial or grants 
management issues:

The Guidelines for Core Centers are available at:  
http://www.niams.nih.gov/rtac/funding/grants/sdrcwww.htm

General information about the NIAMS Core Center Program may be found 
at: 
http://www.niams.nih.gov/rtac/funding/grants/centers_programs.htm#P30

o Direct your questions about scientific/research issues to:

Dr. Julia B. Freeman
Centers Program, EP, 
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza
6701 Democracy Boulevard, Suite 800
Bethesda, MD  20892-4872  (20817 for courier service)
Telephone:  (301)-594-5053
FAX:  (301)-480-4543
Email: freemanb@exchange.nih.gov

o Direct your questions about peer review issues to:

Dr. Cheryl A. Kitt
Director, Extramural Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza
6701 Democracy Boulevard, Suite 800
Bethesda, MD  20892-4872  (20817 for courier service)
Telephone:  (301) 594-2463
FAX:  (301) 480-4543
Email:  kittc@mail.nih.gov

o Direct your questions about financial or grants management matters 
to:

Melinda Nelson
Chief Grants Management Officer, GMB
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza
6701 Democracy Boulevard, Suite 800
Bethesda, MD  20892-4872  (20817 for courier service)
Telephone:  (301) 435-5278
FAX:  301-480-5450
Email:  nelsonm@exchange.nih.gov
 
LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, 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 plan the review.
 
The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent should be sent to:

Dr. Julia B. Freeman
Centers Program, EP, 
National Institute of Arthritis and Musculoskeletal and Skin Diseases
One Democracy Plaza
6701 Democracy Boulevard, Suite 800
Bethesda, MD  20892-4872  (20817 for courier service)
Telephone:  (301)-594-5053
FAX:  (301)-480-4543
Email: freemanb@exchange.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001).  The PHS 398 is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
 
SUPPLEMENTAL INSTRUCTIONS:  The Guidelines for Core Centers are 
available at:  http://www.niams.nih.gov/rtac/funding/grants/sdrcwww.htm

General information about the NIAMS Core Center Program may be found 
at: 
http://www.niams.nih.gov/rtac/funding/grants/centers_programs.htm#P30

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  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 and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, 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: 

Review Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases 
One Democracy Plaza
6701 Democracy Boulevard, Suite 800
Bethesda, MD  20892-4872  (20817 for courier service)
 
APPLICATION PROCESSING: Applications must be received by the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  The CSR will not accept any application that is 
essentially the same as one already reviewed. This does not preclude 
the submission of substantial revisions of applications already 
reviewed, but such applications must include an Introduction addressing 
the previous critique.

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the 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:

o Receive a written critique
o 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 and assigned a priority score
o Receive a second level review by the NIAMS National 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 your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your 
application will also be reviewed with respect to the following:

o PROTECTIONS:  The adequacy of the proposed protection for humans, 
animals, or the environment, to the extent they may be adversely 
affected by the project proposed in the application.

o INCLUSION:  The adequacy of plans to include subjects from both 
genders, all racial and ethnic groups (and subgroups), and children as 
appropriate for the scientific goals of the research.  Plans for the 
recruitment and retention of subjects will also be evaluated. (See 
Inclusion Criteria included in the section on Federal Citations, below)

o DATA SHARING:  The adequacy of the proposed plan to share data. 

o BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

o OTHER REVIEW CRITERIA

Applicants should clearly demonstrate the ways in which the SDRC will 
build the local research program, will support on-going projects and 
will attract both senior and new investigators to skin
diseases research.  Review criteria that 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.  In a competing continuation application, the application 
should document an impact of the Core Center.  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.  

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  April 13, 2003
Application Receipt Date:  May 13, 2003
Peer Review Date:  October/November 2003
Council Review:  January 2004
Earliest Anticipated Start Date:  April 1, 2004

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
 
REQUIRED FEDERAL CITATIONS 

MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD:  Research 
components involving Phase I and II clinical trials must include 
provisions for assessment of patient eligibility and status, rigorous 
data management, quality assurance, and auditing procedures.  In 
addition, it is NIH policy that all clinical trials require data and 
safety monitoring, with the method and degree of monitoring being 
commensurate with the risks (NIH Policy for Data Safety and Monitoring, 
NIH Guide for Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  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 clinical research 
projects unless a clear and compelling justification is 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 clinical research should read the AMENDMENT 
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a 
complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition 
of clinical research; updated racial and ethnic categories in 
compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must 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) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS:  The NIH maintains a policy 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 is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS:  
NIH policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects.  You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of 
research on hESCs can be found at 
http://grants.nih.gov/grants/stem_cells.htm and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  
Only research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov).   It is the responsibility of the applicant to 
provide the official NIH identifier(s)for the hESC line(s)to be used in 
the proposed research.  Applications that do not provide this 
information will be returned without review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom of 
Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

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.   Furthermore, we caution reviewers that their 
anonymity may be compromised when they directly access an Internet 
site.

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 is related to one or more of the priority areas. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance No. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research. and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or 
Health Systems Agency review.  Awards are made under authorization of 
Sections 301 and 405 of the Public Health Service Act as amended (42 
USC 241 and 284) and administered under NIH grants policies described 
at http://grants.nih.gov/grants/policy/policy.htm and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92.

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the 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.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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