RELEASE DATE:  October 2, 2003

PA NUMBER:  PAR-04-002 (This PAR has been reissued, see PAR-06-111)

EXPIRATION DATE: October 25, 2005

Department of Health and Human Services (DHHS)


National Institutes of Health (NIH)


National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 

APPLICATION RECEIPT DATES: February 24, 2004, June 24, 2004, October 22, 2004
                           February 24, 2005, June 24, 2005, October 24, 2005



o Purpose of the PA
o Research Objectives
o Mechanism of Support
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations 

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 of interest 
to the NIAMS. This solicitation will provide support for pilot research that 
is likely to lead to a subsequent individual research project grant (R01).  


The NIAMS Small Grant program is designed to facilitate the entry of 
promising new investigators into research on arthritis and musculoskeletal 
and skin diseases and injuries. Brief summaries of the focuses of the NIAMS' 
Extramural Program branches are listed below. For more detailed information 
about scientific areas of interest to the NIAMS, applicants are encouraged to 
refer to the NIAMS website at  

o  Rheumatic Diseases  

The mission of the Rheumatic Diseases Branch is to promote and support 
research leading to prevention, diagnosis and cure of rheumatic and related 
diseases. The Branch supports basic, epidemiologic, and clinical research on 
etiology, pathogenesis, course, interventions, and outcomes in rheumatic and 
related diseases.  

o  Muscle Biology  

The Muscle Biology Branch encourages and supports research on skeletal 
muscle, its diseases and disorders, and its central role in human physiology 
and exercise. Topics include the molecular structure of muscle and the 
molecular mechanisms that produce force and motion. One focus of this program 
is understanding the alterations in muscle resulting from increased exercise 
regimens and, conversely, the atrophy that follows immobilization during 
injury or illness.  

o  Musculoskeletal Diseases  

This Branch supports studies of the skeleton including bones, joints and 
associated connective tissues. Broad areas of interest include skeletal 
development, metabolism, mechanical properties, and responses to injury. 
Clinical and basic research in the areas of osteoporosis and orthopaedic 
sciences are of particular interest under this program. Other musculoskeletal 
disorders of interest include osteoarthritis, osteogenesis imperfecta, and 
Paget's disease.  The Program supports research in the area of acute and 
chronic injuries of the musculoskeletal system including work related and 
repetitive stress injuries. Research proposals related to the development of 
new technologies with the potential to improve treatment and/or diagnosis of 
skeletal disorders and to facilitate the repair of trauma in the normal 
skeleton are of great interest. In addition, bioengineering, sports medicine 
and musculoskeletal fitness are areas of special research emphasis.  

o  Skin Diseases  

This Branch supports basic and clinical studies of the skin in normal and 
disease states. The wide range of skin diseases under study with NIAMS 
support includes keratinizing disorders such as psoriasis and ichthyosis, 
atopic dermatitis and other chronic inflammatory skin disorders, the 
vesiculobullous diseases such as epidermolysis bullosa and pemphigus, acne, 
and vitiligo. 


This PA will use the National Institutes of Health (NIH) Small Grant (R03) 
Award mechanism. As an applicant, you will be solely responsible for 
planning, directing, and executing the proposed project. The total project 
period for an application submitted in response to this PA may not exceed 
three years. Applicants may request up to $50,000 (direct costs) per year.
This PA uses just-in-time concepts. It also uses the modular budget format. 


It is anticipated that, for FY 2004 and FY 2005, approximately $1.5 million 
(total costs) will be available for the first year of support for this 
initiative. It is anticipated that up to 15 to 20 new grants will be awarded 
each fiscal year 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.


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 Units of State and local governments
o Eligible agencies of the Federal government  
o Foreign institutions are not eligible to apply
o Faith-based or community-based organizations 


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.
o Racial/ethnic minority individuals, women, and persons with disabilities 
are encouraged to apply as principal investigators. 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 and by investigators at 
minority serving institutions.
o Grants awarded through this PA may not be used to support thesis or 
dissertation research. 
o Former and current recipients of Academic Research Enhancement Awards 
(AREA) (R15), Mentored Clinical Scientist Development Awards (K08), Mentored 
Research Scientist Development Awards (K01), Mentored Patient Oriented 
Research Career Development Award (K23), 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. 
o Individuals whose sole previous support has been through pilot and 
feasibility studies (with the exception of R21 support from NIAMS) may apply.  
o 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. 
o The NIAMS will not award a new R03 grant if the project period of the new 
grant would overlap with the project period of a previously awarded NIAMS R03 
grant. In addition, the NIAMS will not accept an R03 application from a 
principal investigator who has held two previous NIAMS R03s. 
o Principal Investigators of research subprojects of Research Program 
Projects (P01) and Centers (P50 and P60) and individuals who have received 
research support in arthritis, musculoskeletal, or skin research from the 
National Science Foundation (NSF) or Department of Veterans Affairs (VA) as 
Principal Investigators are also ineligible.   

Investigators who have questions about eligibility should contact one of the 
program officials listed under Inquiries.


We encourage your inquiries concerning this PA 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 

o Direct your questions about scientific/research issues to:

Alan N.Moshell, M.D.  
Skin Diseases Branch  
National Institute of Arthritis and Musculoskeletal and Skin Diseases 
One Democracy Plaza  
6701 Democracy Blvd., Suite 800, Bethesda, MD  20892-4872  
Telephone:  (301) 594-5017  
FAX:  (301) 480-4543  

o Direct your questions about peer review issues to: 
Glen Nuckolls, Ph.D.  
Review Branch National Institute of Arthritis and Musculoskeletal and Skin 
One Democracy Plaza 
6701 Democracy Blvd, Suite 800  
Bethesda, MD 20892-4872  
Telephone: 301-594-4974
Fax: 301-402-2406  

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

Melinda Nelson  
Grants Management Officer National Institute of Arthritis and Musculoskeletal 
and Skin Diseases One Democracy Plaza  
6701 Democracy Blvd. Suite 800  
Bethesda, MD  20892-4872  
Telephone:  (301) 594-3535  
FAX:  (301) 480-5450  


Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001). Applications must have a Dun and 
Bradstreet (D&S) Data Universal Numbering System (DUNS) number as the 
Universal Identifier when applying for Federal grants or cooperative 
agreements. The DUNS number can be obtained by calling (866) 705-5711 or 
through the web site at . The  DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 available at in 
an interactive format. For further assistance contact GrantsInfo, Telephone 
(301) 710-0267, Email:    


The Research Plan is limited to 10 pages.

The title, "NIAMS Small Grant Program for New Investigators," and number of 
the program announcement (PAR-04-002) 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 in one package to: 

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 and all 
copies of the appendix material must be sent to:  
Glen Nuckolls, Ph.D.  
Review Branch National Institute of Arthritis and Musculoskeletal and Skin 
One Democracy Plaza 
6701 Democracy Blvd, Suite 800  
Bethesda, MD 20892-4872  
Telephone: 301-594-4974
Fax: 301-402-2406  
Applications received after any of the receipt dates listed above will be 
deferred to the next review cycle.  A Principal Investigator may submit only 
one R03 application to the NIAMS in any review cycle. Applicants may not 
submit another research application for the same review cycle in which an R03 
is submitted, if that application involves significant scientific overlap 
with the R03 application.   

APPLICATION RECEIPT DATES: February 24, 2004, June 24, 2004, October 22, 
2004, February 25, 2004, June 24, 2005, October 24, 2005 

requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format. The modular budget grant format simplifies the 
preparation of the budget in these applications by limiting the level of 
budgetary detail. Applicants request direct costs in $25,000 modules. Section 
C of the research grant application instructions for the PHS 398 (re 5/2001) 
at includes step-by-
step guidance for preparing modular grants. Additional information on modular 
grants is available at 

APPLICATION PROCESSING: Applications must be received on or before the 
receipt dates listed on the first page. The CSR will not accept any 
application in response to this PAR 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 a 
substantial revision of an unfunded version of an application already 
reviewed, but such applications bust in an Introduction addressing the 
previous critique.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

Applications submitted for this PAR will be assigned to NIAMS.  Appropriate 
scientific review groups convened by NIAMS in accordance with the standard 
NIH peer review procedures ( will evaluate the 
applications for scientific and technical merit and responsiveness to the 

As part of the initial merit review, all applications will:

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score  
o Receive a written critique 
o Receive a second level review by the National Arthritis and Musculoskeletal 
and Skin Diseases Advisory Council.  


The goals of NIAMS for this Small Grant program are to attract promising new 
investigators to conduct research in the rheumatic, musculoskeletal, and skin 
disease, along with the NIH-wide goals of advancing our understanding of 
biological systems, improving the control of disease, and enhancing health. 
The R03 is a mechanism for supporting discrete, well-defined projects that 
can realistically be expected to be completed within three years and that 
require only a modest level of funding.  Because the research plan is limited 
to 10 pages, a small grant application will not have the same level of detail 
or extensive discussion found in an R01 application. Accordingly, reviewers 
will evaluate the conceptual framework and general approach to the problem, 
placing less emphasis on methodological details and certain indicators 
traditionally used in evaluating the scientific merit of R01 applications 
(e.g., hypothesis driven design, supportive preliminary data). In the written 
comments reviewers will be asked to discuss the following aspects of the 
application 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 assigning the application's 
overall score, weighting them as appropriate for each application.

o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be judged 
likely to have major scientific impact and thus deserve a high priority 
score. For example, an investigator may propose to carry out important work 
that by its nature is not innovative but is essential to move a field 

SIGNIFCANCE:  Does this study address an important problem? If the study is 
descriptive rather than hypothesis driven, are the importance of the data to 
be obtained and their potential value in generating the proposed research 
generate data to answer a specific problem or lead to a larger scale research 
project? 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? 

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? Can the proposed research realistically be 
accomplished within the requested period of support? Is the proposed approach 
appropriate to the state of the science, the stage of the research project, 
and the scope of the work?  Appropriate justification for the proposed work 
can be provided through literature citations, data from other sources, or 
investigator generated data. Reviewers recognize that an individual with 
limited research experience is less likely to be able to prepare a research 
plan with the breadth and depth of that submitted by a more experienced 
investigator. All applications must include a fundamentally sound research 
plan, but reviewers will consider the applicant's prior research experience 
in judging the level of detail provided. Preliminary data are not required.  

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, or will the data to 
be collected provide descriptive information needed to develop a new 
direction or area of research?       

INVESTIGATOR: Based on the quality of the research and academic record, does 
he/she show potential to translate previous knowledge, skills, and research 
experience to areas of interest to NIAMS, and potential to make significant 
contributions to the field? 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 

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?   

In addition to the above criteria, in accordance with NIH policy, all 
applications will also be reviewed with respect to the following:  

subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).
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 will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

be used in the project, the five items described under Section f of the PHS 
398 research grant application instructions (rev. 5/2001) will be assessed.   


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

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  
o  Candidate's potential as an independent investigator 


HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained. 

DATA AND SAFETY MONITORING PLAN:  Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II); efficacy, 
effectiveness and comparative trials (phase III).  The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998:  

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 "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 
a complete copy of the updated Guidelines are available at
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 

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 

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

HUMAN EMBRYONIC STEM CELLS (hESC):  Criteria for federal funding of research 
on hESCs can be found at and at  Only 
research using hESC lines that are registered in the NIH Human Embryonic Stem 
Cell Registry will be eligible for Federal funding (see 
It is the responsibility of the applicant to provide, in the project 
description and elsewhere in the application as appropriate, 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 

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

Applicants may wish to place data collected under this PA 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.

Department of Health and Human Services (DHHS) issued final modification to 
the "Standards for Privacy of Individually Identifiable Health Information", 
the "Privacy Rule," on August 14, 2002.  The Privacy Rule is a federal 
regulation under the Health Insurance Portability and Accountability Act 
(HIPAA) of 1996 that governs the protection of individually identifiable 
health information, and is administered and enforced by the DHHS Office for 
Civil Rights (OCR). Those who must comply with the Privacy Rule (classified 
under the Rule as "covered entities") must do so by April 14, 2003  (with the 
exception of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule reside 
with the researcher and his/her institution. The OCR website 
( provides information on the Privacy Rule, including 
a complete Regulation Text and a set of decision tools on "Am I a covered 
entity?"  Information on the impact of the HIPAA Privacy Rule on NIH 
processes involving the review, funding, and progress monitoring of grants, 
cooperative agreements, and research contracts can be found at

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 PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at 

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under the authorization of Sections 
301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) 
and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All 
awards are subject to the terms and conditions, cost principles, and other 
considerations described in the NIH Grants Policy Statement.  The NIH Grants 
Policy Statement can be found at 

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.

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NIH Funding Opportunities and Notices

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