HIGH RISK RHEUMATIC AND MUSCULOSKELETAL AND SKIN DISEASES RESEARCH    

RELEASE DATE:  October 16, 2003

RFA Number:  RFA-AR-04-002  

Department of Health and Human Services (DHHS)    

PARTICIPATING ORGANIZATIONS:
National Institutes of Health (NIH)
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATIONS:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)  
 (http://www.niams.nih.gov/) 

CATALOGUE OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.486    

LETTER OF INTENT RECEIPT DATE:   November 17, 2003
APPLICATION RECEIPT DATE:       December 16, 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 Supplementary Instructions  
o Peer Review Process  
o Review Criteria  
o Receipt and Review Schedule  
o Award Criteria  
o Required Federal Citations    

PURPOSE OF THIS RFA 

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

Two kinds of experienced and established investigators are sought.  First, 
experienced and established investigators in rheumatic or musculoskeletal or 
skin diseases are encouraged to present a proposal for testing the 
feasibility of a novel idea, resource or technology.  The project should 
represent a clear and distinctly different approach from the investigator's 
current and previous (past 5 years) research.  Second, experienced and 
established investigators with no previous work in rheumatic or 
musculoskeletal or skin diseases are encouraged to apply their expertise to 
research that is relevant to rheumatic or musculoskeletal or skin diseases.  
This request for applications should not be considered for new investigators 
without previous grant experience.    

RESEARCH OBJECTIVES
    
The NIAMS seeks to broaden the base of inquiry in fundamental biomedical, 
biobehavioral, and biomedical technology research by encouraging research 
projects that involve a high degree of innovation and novelty.  Because 
innovative projects may require a preliminary test of feasibility, this 
initiative will provide short-term support for such preliminary work. Each 
research plan should include a brief description of how the proposed project 
represents a high degree of innovation and novelty that complements but does 
not duplicate the applicant's currently funded research. The projects must 
support the NIAMS mission as detailed in the NIAMS Web page, which can be 
found at http://www.nih.gov/niams/about/ep1.htm.  In brief, the NIAMS 
supports research in: a) rheumatic diseases; b) cartilage biology and 
diseases; c) bone biology and diseases (e.g., osteogenesis imperfecta, 
Paget's disease); d) skin biology and skin diseases; e) autoimmune diseases 
(e.g., lupus, rheumatoid arthritis); f) connective tissue diseases; g) 
musculoskeletal diseases (e.g., osteoarthritis, osteoporosis) h) 
musculoskeletal imaging; i) injuries and disorders of the musculoskeletal 
system; j) muscle biology and diseases (e.g., muscular dystrophy); k) 
exercise physiology and musculoskeletal fitness; l) sports injuries; m) 
occupational diseases and injuries; and n) orthopaedic and bioengineering 
topics.    

MECHANISM (S) OF SUPPORT    

This RFA will use the National Institutes of Health (NIH) 
exploratory/developmental research grant, R21, award mechanism.  
Responsibility for the planning, direction, and execution of the proposed 
project will be solely that of the applicant. Applicants may request up to 
$50,000 (direct costs) per year for up to two years.  These awards are not 
renewable.  If desired, the specific aims of the R21 project may be expanded 
and serve as the basis for a larger research grant application (R01) 
submitted prior to the termination of the R21 award. This RFA is a one-time 
solicitation. This RFA uses just-in-time concepts.  It also uses the modular 
budgeting format. (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, 
when an application is submitted with direct costs in each year of $250,000 
or less, the modular budget format should be used.    

FUNDS AVAILABLE    

It is anticipated that for FY 2004, approximately $1,200,000 total costs will 
be available for the first year of support for this initiative. Award of 
grants is contingent upon the receipt of such funds for this purpose.  It is 
anticipated that up to 20 new grants will be awarded under this program.  The 
specific number to be funded will depend on the merit and scope of the 
applications received and on the availability of funds.  Direct costs are 
limited to $50,000 and will be awarded in modules of $25,000, less any 
overlap or other necessary administrative adjustments.  Facilities and 
Administrative costs will be awarded based on the negotiated rates.  
Applicants may request up to two years of support.    

ELIGIBLE INSTITUTIONS 

You may submit (an) application(s) if your institution has any of the 
following characteristics:
    
o For profit or nonprofit 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 Domestic or foreign institutions/organizations
o Faith-based or community-based organizations    

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS    

For this solicitation, individuals with an established research career and 
the skills, knowledge, and resources necessary to carry out the proposed 
research are invited to work with their institutions to develop an 
application for support.  Individuals from underrepresented racial and ethnic 
groups as well as individuals with disabilities are strongly encouraged to 
apply for support from NIAMS programs.    

SPECIAL REQUIREMENTS    

The Background and Significance Section of application must include a brief 
section (one page or less) entitled "Eligibility for High Risk RFA" that 
states the innovative and high risk aspects of the project that distinguish 
it from currently funded projects in the PI's and collaborators' 
laboratories. The following concerns should be specifically addressed:      
    1) Innovation & Novelty: Does the proposed project represent a high 
degree of innovation and novelty?      
    2) Lack of overlap with current work:  Does the proposed project have 
specific overlap with current work from the PI?  If the proposed work is 
complementary to ongoing research, why couldn't it be carried out within the 
framework of currently funded studies?      
    3) High risk: Explain how the high gain potential of the project, if 
successful, offsets the high risk of failure.      
    4) Justification of eligibility of PI: Provide evidence of PI's 
established research career.    

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:  programmatic/general, peer review, and financial or grants management 
issues: Direct inquiries regarding programmatic issues to the most 
appropriate person listed on the web site 
(http://www.niams.nih.gov/rtac/prog_staff/director.htm) according to 
scientific area.    

o For general inquiries about this RFA contact:    

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  
Email: alan_n_moshell@nih.gov    

o Direct your questions about peer review issues to: 
   
Aftab A. Ansari, Ph.D.
Health Scientist Administrator
NIH-NIAMS
6701 Democracy Blvd, Suite 800
Bethesda, MD 20892
Phone: 301-594-4952
Fax: 301-402-2406
Email: ansaria@mail.nih.gov
    
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  
Email:  nelsonm@mail.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 Other participating institutions  
o Number and title of this RFA.    

Although a letter of intent is not required, is not binding, does not commit 
the sender to submit an application, and does not enter into the review of a 
subsequent application, the information that it contains allows IC staff to 
estimate the potential review workload and plan the review.  The letter of 
intent should be sent to:
    
Aftab A. Ansari, Ph.D.
Health Scientist Administrator
NIH-NIAMS
6701 Democracy Blvd, Suite 800
Bethesda, MD 20892
Phone: 301-594-4952
Fax: 301-402-2406
Email: ansaria@mail.nih.gov

SUBMITTING AN APPLICATION    

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&B) 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 http://www.dunandbradstreet.com/. The DUNS number 
should be entered on line 11 of the face page of the PHS 398 form. The PHS 
398 document 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.
  
SUPPLEMENTARY INSTRUCTIONS:  The research plan (a-d) is limited to 10 pages.  
APPLICATIONS THAT EXCEED THE PAGE LIMIT WILL BE RETURNED WITHOUT REVIEW.  A 
Preliminary Data section is not required.  If included in R21 applications, 
it should not exceed one page.  The Background and Significance Section of 
application must include, at the beginning, a brief section (one page or 
less) entitled "Eligibility for High Risk RFA" in which the PI specifically 
addresses the following concerns:  1) Innovation & Novelty: Does the proposed 
project represent a high degree of innovation and novelty?  2) Lack of 
overlap with current work:  Does the proposed project have specific overlap 
with current work from the PI?  If the proposed work is complementary to 
ongoing research, why couldn't it be carried out within the framework of 
currently funded studies?  3) High risk: Explain how the high gain potential 
of the project, if successful, offsets the high risk of failure. 4) 
Justification of eligibility of PI: Provide evidence of PI's established 
research career.  An appendix may be included in the application; however, 
the appendix is not to be used to circumvent the page limit of the research 
plan. 

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting 
up to $250,000 per year in direct costs must be submitted in a modular grant 
format.  The modular 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 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step by step 
guidance for preparing modular grants.  Additional information on modular 
grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.    

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 (AR_03_009) 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/labels.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 and all 
copies of the appendix material must be sent to:    

Aftab A. Ansari, Ph.D.
Health Scientist Administrator
NIH-NIAMS
6701 Democracy Blvd, Suite 800
Bethesda, MD 20892
Phone: 301-594-4952
Fax: 301-402-2406
Email: ansaria@mail.nih.gov

APPLICATION PROCESSING: Applications must be received on or before 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.

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.    

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.  
However, when a previously unfounded application, originally submitted as an 
investigator-initiated application, is to be submitted in response to an RFA, 
it is to be prepared as a NEW application. That is, the application for the 
RFA must not include an Introduction describing the changes and improvements 
made, and the text must not be marked to indicate the changes from the 
previous unfunded version of the application.  

PEER REVIEW PROCESS  

Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by the NIAMS.  Incomplete applications will not be reviewed.  
In addition, applications will be reviewed by NIAMS for responsiveness to the 
RFA after receipt of application and prior to review.  If the application is 
not determined to be responsive to the RFA, NIAMS staff will either return 
the application to the applicant or contact the applicant to clarify 
questions of suitability.    

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 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 written critique    
o Receive a second level review by the National Arthritis and Musculoskeletal 
and Skin Diseases Advisory Council. 

REVIEW CRITERIA    

The goals of NIH supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  For 
this initiative, the proposed project must have the potential for developing 
groundbreaking technology or methodology that may lead to significant 
expansion of biomedical research horizons, precipitate a paradigm shift in 
research, or lead to substantial improvements in human health.  In the 
written comments, reviewers will be asked to evaluate the application in 
order to judge the likelihood that the proposed research will have a 
substantial impact on the pursuit of these goals. The scientific review group 
will address and consider each of the following criteria 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 work that by its 
nature is not innovative but is essential to move a field forward.

SIGNIFCANCE:  Does the proposed study have potential for the development of 
groundbreaking technology or methodology that may lead to significant 
expansion of biomedical research horizons, precipitate a paradigm shift in 
research, or lead to substantial improvements in human health?  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?    

INNOVATION:  Does the project employ novel concepts, approaches or methods? 
Are the aims original and innovative?  Does the project challenge existing 
paradigms or seek to develop new methodologies or technologies?  Does the 
high gain potential of the project, if successful, offset the high risk of 
failure? 

INVESTIGATOR: Is the investigator appropriately trained and well suited to 
carry out this work? Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers (if any)?   

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?    

ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, the following 
items will be considered in the determination of scientific merit and the 
priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
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).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 in the sections on Federal Citations, 
below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals are to 
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.  

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

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: November 17, 2003
Application Receipt Date: December 16, 2003
Peer Review Date: June/July 2004
Council Review: September 2004
Earliest Anticipated Start Date: December 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 

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. 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

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: 
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 "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 are 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://stemcells.nih.gov/index.asp 
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, 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 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 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  The 
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 
(http://www.hhs.gov/ocr/) 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 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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 at http://www.cfda.gov/ 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 
http://grants.nih.gov/grants/policy/policy.htm 

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.    


Return to Volume Index

Return to NIH Guide Main Index


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.