TRANSLATIONAL RESEARCH IN DENTAL PRACTICE-BASED TOBACCO CONTROL INTERVENTIONS

RELEASE DATE:  October 7, 2002
 
RFA:  DE-03-007 

National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov)
National Institute on Drug Abuse (NIDA)
 (http://www.nida.nih.gov)

LETTER OF INTENT RECEIPT DATE:  February 24, 2003

APPLICATION RECEIPT DATE:  March 24, 2003 

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o    Research Objectives
o    Mechanism(s) of Support 
o    Funds Available
o    Eligible Institutions
o    Individuals Eligible to Become Principal Investigators
o    Purpose of This RFA
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 on Drug Abuse (NIDA) and the National Institute 
of Dental and Craniofacial Research (NIDCR) are committed to 
stimulating innovative research on dental practice-based tobacco 
control interventions, as well as studies which use dentistry as a 
model to clarify processes underlying or influencing the translation of 
research findings into clinical practice. Tobacco control provides an 
important, public health-relevant venue for studying the translation of 
basic and clinical research findings into clinical practice.  Clear, 
science-based clinical guidelines for implementing tobacco prevention 
and tobacco cessation are available.  Also, numerous studies have 
documented harmful impacts of tobacco use on oral diseases and dental 
treatment outcomes.   As yet, however, evidence suggests that the 
preponderance of US dental clinicians are not utilizing optimal 
science-based approaches to prevent or reduce the use of oral health-
harming smoked or smokeless tobacco products. 
 
This RFA aims to stimulate research to: 1) develop and test 
interventions that translate findings from alcohol, tobacco and other 
drug prevention and treatment research into effective, dental practice-
based tobacco control strategies, 2) translate findings from other 
theoretically-grounded basic or behavioral science research into 
effective dental practice-based tobacco control strategies, or 3) 
clarify processes that underlie or influence the translation of 
tobacco-related knowledge into clinical dental practice.

RESEARCH OBJECTIVES

Background

The initiation of smoked or smokeless tobacco use is promoted by a wide 
array of familial, peer, community and media factors.  Ongoing use is 
maintained primarily by the addictive nature of nicotine, although 
other constituents of tobacco products also play a role.  In addition, 
cues that have become conditioned to the use of tobacco can influence 
subsequent use, as well as the relapse to use that often accompanies 
quit attempts.  Epidemiological studies indicate that experimentation 
with tobacco products typically begins in early adolescence.  Addiction 
often develops rapidly, with the presence of addiction often 
demonstrable early in an individual's history of use.  Thus, preventing 
initiation of tobacco use is critical.  Various preventive strategies 
involving family, peer and school, community, or media influences have 
been studied and found to influence use, age at initiation of tobacco 
use, and relative probabilities of tobacco use and addiction in 
adulthood. Treatment of tobacco addiction in adults typically 
incorporates behavioral support strategies in conjunction with nicotine 
replacement therapies (NRT), such as the nicotine patch, polacrilex 
gum, or Zyban (bupropion).  Contemporary treatment research is 
exploring other approaches, for example medications such as clonidine, 
nortryptiline, and combinations of bupropion with NRTs.  

I. Changing clinicians' practice behaviors related to preventing, 
reducing, monitoring, or treating tobacco use/nicotine addiction.  

In theory, front-line clinicians are in an ideal position to identify 
problematic health behaviors and to intervene promptly via preventive 
or treatment strategies and/or referral.  Evidence from randomized 
trials and observational studies demonstrates that health care 
providers who intervene with smokers can reduce their patients' tobacco 
use. Various approaches to help patients quit smoking have been 
demonstrated to be effective in outpatient health care settings.   Quit 
rates generally become higher as the interventions offered by the 
health provider become more frequent and intensive.   Multi-modality 
interventions, including identification, counseling, education, 
pharmacological aids, and follow-up have more powerful and consistent 
behavioral effects than do unidimensional approaches, such as advice 
alone.  Brief clinic-based interventions have been shown to increase 
patient smoking cessation rates.  In 1989, the National Cancer 
Institute developed recommendations for physicians treating patients 
who smoke.  This recommended approach includes four steps – ask about 
smoking, advise smokers to stop, assist those who want to stop, and 
arrange adequate follow-up.  In 1996, the Agency for Health Care Policy 
Research (now the Agency for Health Research Quality) recommended a 
five-step approach as a guideline for primary care providers.  Similar 
to the original approach, it integrates an additional step, that of 
assessing the patient's willingness to stop, after the provider has 
already asked about tobacco use and advised the patient to quit.  
Several studies have shown that brief advice on smoking cessation, 
delivered either by physicians or dentists, produces demonstrably 
beneficial overall reductions in tobacco use.  Research has also shown 
that the effectiveness of provider-delivered smoking cessation 
interventions is increased by training, the use of screening systems or 
chart identifiers to indicate patients' tobacco status, and the use of 
cues or reminders to intervene with smokers. 

While practice-based screening and treatment to reduce use of tobacco 
products are effective, tobacco control interventions remain under-
utilized in both medical and dental settings.  Some significant 
barriers to implementing tobacco or substance abuse screening or 
interventions in health care settings have been identified.  Barriers 
clinicians report include: patient resistance and alienation, low 
success rates, lack of time, lack of reimbursement, lack of 
organizational support, and lack of appropriate patient education 
materials and referral resources. 

Findings indicate that many primary care providers do not see 
themselves as adequately prepared or competent to treat smokers or 
other patients with substance abuse problems.   Engaging in training 
and educational programs has, however, been demonstrated to change 
practice behaviors.  For example, physicians who had received formal 
training in smoking cessation were observed to spend more time 
counseling patients to quit smoking than did their counterparts who 
lacked this extra training.  Similarly, a brief training program 
teaching internal medicine and family practice residents to counsel 
patients to stop smoking resulted in increasing both their observed 
cessation counseling skills and their reported willingness to employ 
these techniques later.

II. Tobacco Use and Oral Health.  

Tobacco use has serious, costly adverse effects on oral health.  
Studies indicate that all forms of tobacco, including cigarettes, 
cigars, pipes and smokeless tobacco products, can cause oral and 
pharyngeal cancers. Smoking is known to be a major risk factor in adult 
periodontitis.  Strong epidemiological and clinical evidence supports 
the view that fully one-half of the periodontitis cases in the US can 
be attributed to cigarette smoking and that tobacco use increases risks 
for a wide range of oral soft tissue changes.  Tobacco use also 
substantially reduces probabilities of successful outcomes from 
periodontal therapies and dental implants, impairs oral wound healing, 
and creates tooth discoloration and other oral changes which help fuel 
demand for costly dental interventions. The American Dental Association 
(ADA) Summary of Policy and Recommendations Regarding Tobacco, 
(http://www.ada.org/prof/prac/issues/statements/tobac.html) "…urges 
its members to become fully informed about tobacco cessation 
intervention techniques to effectively educate their patient to 
overcome their addiction to tobacco".  However, there is limited 
evidence that this policy statement has been widely implemented.  
Findings from the ADA's 1997 Survey of Current Issues in Dentistry: 
Tobacco Cessation Efforts Among Dentists indicate that 60% of 
respondents reported they routinely asked about tobacco use and 40% 
reported they routinely advised tobacco users to quit.  (However, 
dentists interested in tobacco cessation may have been more likely to 
respond to the survey).  In contrast, a recent study of dental patients 
revealed that only 24% of smokers and 18% of smokeless tobacco users 
who had seen a dentist in the past year reported that their dentist had 
advised them to quit. 

Recently published U.S. Public Health Services clinical guidelines on 
treating tobacco use and dependence provide evidence-based, practical 
methods which dental professionals can utilize.  Despite the 
availability of such guidelines, their translation into practice has 
lagged and little research has focused on developing the means to 
accelerate this process.   Recent studies indicated that about one-half 
of dental schools include didactic training in counseling tobacco users 
to quit, and less than one-half of dental school clinics and dental 
hygiene programs provide any significant level of clinical tobacco 
intervention services.  Studies from the mid-1990s indicated that at 
that time only 25% of dental schools were using health history forms 
that included any questions about tobacco use. 

U.S. survey data for 1996-1997 indicates that 63 percent of adults aged 
18-65 years and 72% of youth 5-18 years had a dental visit during the 
past twelve months. Moreover, many dental visits are regularly 
scheduled and preventively oriented, typically involve longer intervals 
of interaction than most medical visits, and often dental patients 
return to the same dental providers regularly across years or even 
decades.  Thus, members of the dental profession may be well positioned 
to make a unique contribution to influencing tobacco use and 
reinforcing sustained reductions in tobacco use in a substantial 
proportion of America's youth and adults. 

III. Adoption/Diffusion.  

Research on the dissemination of information to health care providers 
indicates that printed materials (including journal articles) seldom 
have a strong effect on providers' behavior.  Based on models of 
behavior change, information alone is often not sufficient to produce 
enduring behavioral changes.  Additional steps are often required to 
help motivate, facilitate, and reinforce changes in entrenched 
behaviors.  From the complementary perspectives of social influence 
research, health care providers' behaviors are also accessible to 
change through addressing regulatory, normative, economic, and peer 
influences.  Examples of regulatory influence include third party 
reimbursement policies, the threat of malpractice and sanctions by peer 
review or other authoritative bodies.  Normative influences are 
especially critical during the early professional training of health 
care providers.  Interventions conducted during professional training 
or bridging the transition between training and early years of practice 
provide some unique opportunities to test impacts of  normative 
influences on subsequent practice behaviors.   In contrast, different 
strategies and interventions may be more powerful in changing the 
clinical practice behaviors of well-established, experienced health 
care providers.  Research addressing the translation of tobacco control 
strategies into practice at various points throughout dental providers' 
career trajectories is specifically encouraged.

Scope

This RFA is intended to stimulate well-designed translational research that 
can ultimately provide the basis for more effective tobacco control efforts 
by dental professionals within a wide array of dental health care delivery 
settings. Studies focused on identifying key processes influencing 
translation of effective tobacco prevention/cessation strategies into 
clinical dental practice, as well as intervention research to test and 
improve tobacco prevention and cessation measures within dental settings 
are specifically encouraged.  A number of basic science research themes are 
potentially applicable to developing more effective dental-practice based 
tobacco interventions. Also, prevention and treatment strategies shown to 
be effective as applied to other health conditions may prove applicable 
within dental settings to help prevent tobacco initiation, or to reduce 
dental patients' tobacco dependence and addiction.

Studies may test innovative approaches to accelerate dental care 
providers' adoption and maintenance of effective tobacco control 
procedures, such as preventing tobacco use in non-users, helping current 
users to quit, providing long-term feedback and reinforcement to maintain 
non-use, and educating dental patients and the public regarding specific 
oral health risks associated with tobacco use.  To the extent feasible, 
translational studies should be grounded in theory and test both immediate 
and longer-term effects. Investigators may focus on interventions 
initiated during the professional education process or early clinical 
training, at the transition between training and professional practice, or 
within established dental practice settings.  

This RFA also encourages studies targeting changes in tobacco-related 
knowledge, attitudes and practices of practicing dental professionals, 
including dental hygienists, working with different patient populations 
and within different practice settings (e.g., dental HMO, general or 
specialty dental practice settings).   Cross-disciplinary research 
projects that foster collaboration between basic and clinical researchers 
are specifically encouraged. 

Illustrative examples of studies appropriate to this initiative include 
the following: 

o  Identify and test measures to accelerate translating basic or 
clinical science findings on health risks of tobacco use and effective 
approaches for tobacco prevention and cessation into more widespread 
clinical practice, using dentistry as a model;

o  Develop and test interventions aimed at translating findings from 
drug dependence and addiction research into dental practice-based 
tobacco control strategies;

o  Study factors influencing the adoption and acceptability of dental 
practice-based prescription of nicotine replacement therapies or other 
drugs which have been demonstrated to improve tobacco quit rates; 
conduct intervention studies to increase the acceptability and 
effective use of such therapies in dental settings;

o  Identify and characterize determinants of dental professionals' 
adoption, implementation, and long-term maintenance of practice 
behaviors congruent with evidence-based clinical guidelines for tobacco 
prevention and cessation;

o  Use untapped findings on cognitive factors such as decision-making, 
automatic vs. controlled thinking, affective mediators and modulators 
of cognition to help develop and pilot test innovative tobacco 
prevention and cessation programs and to develop more effective 
strategies that can be used in clinical dental practice;

o  Identify relationships between dental providers' levels of knowledge 
concerning the oral health effects of tobacco and their clinical 
decision-making and practice behaviors;

o  Refine and test methods and results associated with delivering 
motivational interviewing or other tobacco counseling approaches within 
dental settings, and test such interventions involving various dental 
team members;

o  Develop and test methods that capitalize on the known effects of 
tobacco use on dental treatment outcomes and/or diminished dental 
treatment options as a result of  the patient's continued tobacco use 
(e.g., poor prognosis for successful dental implants, premature tooth 
loss in diabetic patients) to help motivate reduced use of tobacco 
products or tobacco cessation in special patient groups;

o  Adapt, develop, test, and compare the effectiveness of training 
programs intended to influence dental health providers' attitudes, 
knowledge, and skills concerning dental practice-based tobacco 
prevention or cessation, providing particular attention to the 
assessment of longer term changes in actual practice behaviors.

This list is illustrative and not intended to be inclusive.  
Investigators are encouraged to propose other studies related to the 
adoption and translation of science-based tobacco control measures 
within dental educational and dental practice settings.  They are also 
encouraged to contact the NIDCR and NIDA research/science staff listed 
later in this RFA with specific questions they may have regarding 
whether a topic is responsive.

For purposes of this RFA, NIDA will assume primary programmatic 
responsibility for all applications involving phase I or phase II 
clinical trials.  Moreover, the applicant needs to consult with NIDA 
program staff prior to the preparation of any such application.

MECHANISM OF SUPPORT

Applicants responding to this RFA may use the NIH Research Project 
Grant (R01) or Exploratory/Developmental Grant (R21) award mechanisms. 
As an applicant you will be solely responsible for planning, directing, 
and executing the proposed project.   This RFA is a one-time 
solicitation.  Future unsolicited, competing-continuation applications 
based on this project will compete with all investigator-initiated 
applications and will be reviewed according to the customary peer 
review procedures.  The anticipated award date is September 1, 2003.

This RFA uses just-in-time concepts. It also uses the modular as well 
as the non-modular budgeting format (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less use the modular format.  Otherwise follow 
the instructions for non-modular research grant applications.

R21 applications only:  Use of the R21 mechanism to support pilot 
studies is intended to encourage innovative new research directions and 
the exploration of approaches and concepts new to a particular area or 
study population.  As such, this mechanism encourages the entry of 
investigators to a field, as well as encouraging new research 
approaches and new collaborations.  R21 applications will be expected 
to provide less preliminary data than would be the case for other 
funding mechanisms.  Applicants should, however, make clear that the 
proposed pilot research is scientifically sound, that the long-term 
research goals are both scientifically significant and relevant to the 
aim of tobacco control, the qualifications of the investigators are 
appropriate, and resources available to the investigators are adequate 
for the work proposed.  An R21 grant cannot be renewed.  If additional 
research support is necessary, investigators could then apply for 
further funding through the regular research grant (R01) mechanism.  

FUNDS AVAILABLE

NIDCR and NIDA intend to commit a total of $2,000,000 in FY2003 to fund 
6 to 8 new grants in response to this RFA.  An applicant may request a 
project period of up to 2 years for an R21 or up to 5 years for an R01 
application.  R01 applicants may request a budget for direct costs of 
up to $375,000 per year.  An R21 applicant may request a project period 
of up to 2 years and a budget with direct costs of up to $150,000 (6 
budget modules) per year.   Because the nature and scope of the 
proposed research will vary from application to application, it is 
anticipated that the size and duration of each award will also vary.  
Although the financial plans of the NIDCR and NIDA include 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) R01 or R21 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  

Foreign institutions are not eligible under this RFA; however, a 
domestic institution may, as scientifically appropriate, propose 
research that includes foreign components.

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 

Grantees will be expected to attend a one and one-half day meeting 
annually at or near NIH, Bethesda, MD, to share results and provide an 
opportunity for collective problem solving.  Applicants should budget 
travel funds to attend this annual meeting in their requested budget. 
The travel costs requested should be sufficient to permit attendance by 
either the principal investigator and one additional investigator (for 
R01 awards) or the principal investigator solely (for R21 awards). 

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:

Direct scientific/research questions related to tobacco prevention and 
control studies within dental educational settings or involving the 
transition from professional education into clinical practice to:

Patricia S. Bryant, PhD
Director, Behavioral and Social Sciences Research Program
Clinical, Epidemiology and Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental and Craniofacial Research 
National Institutes of Health 
45 Center Drive, Room 4An24E
Bethesda, MD 20892-6402
Telephone:(301)594-2095
Fax:(301) 480-8318
Email: Patricia.Bryant@nih.gov

Direct scientific/research questions related to tobacco prevention and 
control studies involving dental clinicians within private dental 
practice settings or other dental care delivery settings to:  

Maria Teresa Canto, DDS, MPH
Director, Population Sciences Research Program
Clinical, Epidemiology & Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute Dental & Craniofacial Research 
National Institutes of Health 
45 Center Drive, Room 4AN24K
Bethesda, MD  20892-6401
Telephone:(301) 594-5497
Fax: (301) 480-8319
E-mail: maria.canto@nih.gov

Direct scientific/research questions related to the translation of 
basic science findings into practice-based tobacco research or relevant 
clinical trials within dental settings to:

Herbert Weingartner, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse 
National Institutes of Health 
6001 Executive Blvd.
Bethesda, MD 20892-9555
Telephone 301-435-1321
Fax 301-594-6043
E-mail: herbw@nih.gov
		
Direct scientific/research questions related to the translation of 
research on the treatment of drug use, dependence, or addiction into 
tobacco interventions or relevant clinical trials within dental 
settings to:

Debra Grossman, M.A.
National Institute on Drug Abuse 
National Institutes of Health 
6001 Executive Boulevard, Room 4123
Bethesda, MD  20932
Telephone: (301) 443-0107
Fax: (301) 443-6814
E-mail: dg79a@nih.gov

Direct scientific/research questions regarding the translation of 
research on the prevention of drug use, dependence, or addiction into 
tobacco interventions or relevant clinical trials within dental 
settings to: 

Shakeh Jackie Kaftarian, Ph.D.
Health Scientist Administrator
National Institute on Drug Abuse 
National Institutes of Health 
6001Executive Blvd, Rm 5153
Rockville, MD 20852
Telephone:301-443-8892
Fax: 301-480-2542
E-mail: jk362j@nih.gov

Direct questions about peer review issues to:

H. George Hausch, Ph.D.
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health 
Building 45, Room 4AN-44F
Bethesda, MD  20892-6402
Telephone:  (301) 594-2904
FAX:  (301) 480-8303
Email:  George.Hausch@nih.gov

Direct questions about financial or grants management matters to:

Anne Welkener
Acting Chief
Grants Management Office
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44K
Bethesda, MD  20892-6402
Telephone: (301) 594-4800
FAX:  (301) 480-8303
Email: Ann.Welkner@nih.gov

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
FAX:  (301) 594-6847
Email:  gf6s@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. Hausch at 
the address listed above. 

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.

For R21 applicants, PHS 398 requirements should be followed, with the 
exception of those specific modifications provided for in the R21 
application instructions provided at the URL 
http://www.nidcr.nih.gov/funding/rfa/r21applications_nida.asp.   R01 
or R21 applications not conforming to the requested format will be 
returned to the applicant without review.     

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: 

Applications requesting up to $250,000 per year 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.  Applicant 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 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:

H. George Hausch, Ph.D.
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, MD  20892-6402

APPLICATIONS HAND-DELIVERED BY INDIVIDUALS TO THE NATIONAL INSTITUTE OF 
DENTAL AND CRANIOFACIAL RESEARCH WILL NO LONGER BE ACCEPTED.  This policy 
does not apply to courier deliveries (i.e., FEDEX, UPS, DHL, etc.). This 
change in practice is similar and consistent with the policy for 
applications addressed to the Centers for Scientific Review as published 
in the NIH Guide Notice 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-012.html.

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 participating ICs.  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 NIDCR 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 National Advisory Dental 
Research Council and the National Advisory Council on Drug Abuse.

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

The scientific review group will address and consider each of these 
criteria in assigning your application's overall score, weighting them 
as appropriate for each application.  Your 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, 
you may propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

(1)  SIGNIFICANCE:  Does your study address an important problem? If 
the aims of your application are achieved, how do they advance 
scientific knowledge?  What will be the effect of these studies on the 
concepts or methods that drive this field?

(2)  APPROACH:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well integrated, and appropriate to the 
aims of the project?  Do you acknowledge potential problem areas and 
consider alternative tactics?

(3)  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 employ innovative approaches for assessing 
sustainability within health care delivery settings?

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

(5)  ENVIRONMENT:  Does the scientific environment in which your 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, your 
application will also be reviewed with respect to the following:

o  PROTECTIONS:  The adequacy of the proposed protection for humans 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.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:               February 24, 2003
Application Receipt Date:                    March 24, 2003
Peer Review Date:                            June/July 2003
Council Review:                              August 2003
Earliest Anticipated Start Date:             September 1, 2003

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 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 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://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. 
Specifically it addresses Healthy People 2010 objectives related to 
oral health, drug dependence and addiction, and tobacco.  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 Nos. 93.121 (NIDCR) and 93.279 (NIDA) 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.
 
REFERENCES  

Applicants may wish to view selected references, which are available at 
the following URL (http://www.nidcr.nih.gov/funding/rfa/references_nida_r21.asp) 

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