RELEASE DATE:  October 3, 2003
RFA Number:  RFA-CA-04-012 (see NOT-CA-03-040, NOT-CA-03-042, and NOT-CA-03-043)

National Institutes of Health (NIH) 


National Cancer Institute (NCI) 
National Institute on Drug Abuse (NIDA)  
National Institute on Alcohol Abuse and Alcoholism (NIAAA) 


This RFA is a reissue of RFA-CA-98-029, which was published in the NIH 
Guide on December 11, 1998.

o Purpose of this RFA
o Research Objectives
o Mechanism 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 Pre-Application Meeting
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


The National Cancer Institute (NCI), the National Institute on Drug 
Abuse (NIDA), and the National Institute on Alcohol Abuse and 
Alcoholism (NIAAA) invite center grant applications (P50) for 
Transdisciplinary Tobacco Use Research Centers (TTURCs).   The reissue 
of this RFA reflects recognition of the public health impact of tobacco 
use and the scientific need for integrative transdisciplinary research 
across the full spectrum of basic and applied research on tobacco use 
and control.  Tobacco use control and addiction research spans diverse 
areas ranging from molecular biology, genetics, neuroscience and 
epidemiology to imaging, primary care, behavioral science, 
communication, health policy, biostatistics, economics and marketing.  
Collaborative research across disciplinary boundaries permits 
scientific exploration of the complex and interactive determinants of 
tobacco use.  Transdisciplinarity is a process by which researchers 
work jointly using a shared conceptual framework that draws together 
discipline-specific theories, concepts, and approaches to address a 
common problem.

A TTURC is required to have a minimum of three major research projects; 
must provide career development opportunities for new investigators and 
established investigators who wish to pursue active research careers in 
transdisciplinary tobacco use research; provide developmental funds for 
innovative pilot projects; and participate with other TTURCs on a 
regular basis to share information, assess scientific progress in the 
field, identify new research opportunities, and promote inter-TTURC 
collaborations to promote discovery and to resolve areas of scientific 
controversy.  The use of shared methodologies between TTURCs will 
promote collection of comparable data across several lines of research 
and allow greater generalizability of results.  The centers also are 
encouraged to form partnerships with industry, e.g., to advance 
medication development.  Collaborations with NIH intramural programs 
also are encouraged.  In addition, collaborations also should be 
considered with universities, public health agencies, and other 
organizations that have strong ties to minority communities with high 
smoking rates.  Each TTURC and the "network" of TTURCs are expected to 
conduct research that will lead to major scientific advances in 
knowledge about tobacco use and its prevention and treatment.  The 
centers funded by this initiative are expected to both broaden and 
integrate the expertise required to advance the science of tobacco use 
and control.  Centers are expected to be creative, innovative, and 
involve investigators from a broad range of disciplines and 
perspectives. It is expected that the research will engage the 
appropriate range of transdisciplinary tools and approaches to allow 
significant advances to be made, and to translate research findings to 
the next step in utility and application.  

The purpose of the TTURCs is to facilitate a transdisciplinary approach 
to the full spectrum of basic and applied research on tobacco use, 
including: etiology of tobacco use and addiction (including the impact 
of advertising and marketing), prevention of tobacco use, the treatment 
of tobacco use and addiction, the identification of biomarkers of 
tobacco exposure, and the identification of genes related both to 
addiction and susceptibility to harm from tobacco.  The translational 
nature of these research programs will inform public health efforts to 
reduce the disease burden of tobacco use.  

Cigarette smoking remains firmly entrenched in American society today, 
although the demographics of smokers vary from those when the first 
Surgeon General's Report on Smoking was published nearly 40 years ago.  
Approximately 48 million adult Americans, representing 25% of the 
population, are smokers.  Overall, smoking prevalence and the 
trajectory of tobacco use initiation among America's youth continue to 
be alarming: 26.7% of 12th graders report current smoking and 16.9% 
report daily smoking.  About 1/2 to 1/3 of teens who try smoking will 
become regular smokers and 75% of daily teen smokers will smoke as 
adults. This is particularly striking given the increase in policies 
regulating smoking, litigation against the tobacco industry, and 
heightened public awareness of the negative health consequences of 

Smoking has been the chief preventable cause of illness and death in 
the U.S. for more than three decades and is responsible for 440,000 
deaths annually.  Cigarette smoking is a primary cause of death from 
lung cancer, coronary heart disease, chronic obstructive pulmonary 
disease, and stroke.  Worldwide, more than 3 million people will die 
every year because of tobacco making it the largest preventable cause 
of death in history.  The World Health Organization estimates that this 
figure will increase to nearly 10 million annual deaths by 2030. 

In order to understand the epidemiology and natural history of tobacco 
use and nicotine addiction, an integrated approach is required to 
explore the interplay of social, psychological, biological and genetic 
factors.   Social influences are broad, including peer and family 
modeling, tobacco, industry marketing and media influences.  Depressed 
or anxious mood and attention-deficit hyperactivity disorder are 
examples of psychological factors that affect smoking, from initiation 
to maintenance to cessation.  The effects of these overarching 
determinants are mediated by behavioral, neurochemical, and 
physiological factors to influence tobacco use, dependence, cessation, 
and relapse in the individual.  

Because of the intransigence of tobacco use and its disease 
consequences, and its complex, multidimensional determinants, the 
scientific community called for new multilevel research models and 
paradigms that were integrated across disciplines.  Scientific leaders 
identified transdisciplinary research as having the potential to 
accelerate discovery.   Transdisciplinary research is differentiated 
from other cross-disciplinary research by its degree of collaboration 
and conceptual integration.  

Renewal of this RFA is responsive to NCI's Bypass Budget:  "renew and 
expand support of the Transdisciplinary Tobacco Use Research Centers 
program in collaboration with relevant public and private 
organizations"; facilitate rapid development from discovery to 
application by using established mechanisms and creating novel special 
awards to encourage transdisciplinary and collaborative research.


TTURCs are expected to conduct research that will lead to major 
scientific advances in knowledge of tobacco use, nicotine addiction, 
prevention and treatment interventions, and the translation of this 
knowledge into practice.  There are several overarching goals:

o  Increase the number of investigators from relevant disciplines who 
focus on the study of tobacco use as part of transdisciplinary teams. 

o  Generate basic research evidence to improve understanding of the 
etiology and natural history of tobacco use.

o  Produce evidence-based tobacco use interventions that can translate 
to the community and specific understudied or underserved populations.

o  Increase the number of evidence-based interventions that are novel, 
including the development, testing and dissemination of innovative 
behavioral treatments and prevention strategies based upon findings 
from basic research. 

o  Train transdisciplinary investigators capable of conducting cutting-
edge tobacco use research.
o  Increase the number of peer-reviewed publications in the area of 
tobacco use, nicotine addiction, and treatment.

The TTURC initiative is fundamentally translational in nature, and it 
is anticipated that success will require extensive collaboration.  In 
order to maximize effectiveness and minimize budgetary needs, it is 
expected that applicants will avail themselves of existing 
infrastructure wherever possible.  These collaborations, while strongly 
encouraged, are not required (nor are centers limited to collaborations 
with those listed here).  For example, TTURC applications with 
medication development and delivery dimensions might collaborate with 
the NIDA Clinical Trials Network (CTN), with NIDA's Intramural Research 
Program, with SAMHSA, with the Veteran's Administration Cooperative 
Studies Program or with NCI's designated Comprehensive Cancer Centers, 
Cancer Information Service, Special Populations Networks, and other 
NCI-funded research projects, such as the Cancer Family Registries, 
Mouse Models Consortium, Cancer Genetics Networks, Rapid Access to 
Preventive Intervention Development (RAPID) medication development 
program, Centers for Excellence in Cancer Communications (CCERS) and 
the  Specialized Programs of Research Excellence (SPOREs).  Other 
organizations that may be considered are the Centers for Disease 
Control and Prevention, the American Cancer Society and other voluntary 
health associations, the Robert Wood Johnson Foundation, National 
Science Foundation grantees, and industry. In addition, collaborations 
should be considered with universities, including Schools of Public 
Health, historically Black Colleges and Universities, public health 
agencies, substance abuse agencies, community technology centers and 
other organizations. The active participation of advocacy groups and 
appropriate community organizations is encouraged. Relevant 
collaborations with NIH intramural programs can be included as well.   


There is an urgent need for new investigators who have the quality and 
breadth of training necessary to conduct cutting-edge research related 
to tobacco use and nicotine addiction.  Such training should expose 
investigators to the multiple levels of research that address tobacco-
related issues.  Because tobacco research scientists are widely 
dispersed by geography and discipline, this type of training is 
difficult to obtain.  By emphasizing meaningful integration and 
collaboration among scientists, the centers will provide a challenging 
and unique venue for training the next generation of tobacco 
researchers.  Career development should not be limited to doctoral or 
post-doctoral scientists; cross-training of established investigators is 
also encouraged.

Developmental/pilot research program

Centers must establish a developmental research plan with processes for 
conceiving, vetting, and evaluating studies that allow exploration of 
novel directions, especially those that might arise with the 
progression of the major projects.  Promising pilot studies are 
expected to spawn applications for independent funding.


Investigators should represent a broad range of disciplines working 
together to increase knowledge across the full spectrum of basic and 
applied research on tobacco use and addiction.   Meaningful 
collaboration across geographically separate sites is permitted, and 
will be expected across the funded Centers.  

The level of specialization in different dimensions of tobacco use and 
control research will vary from center to center, e.g., themes, topics, 
points on the discovery-development-delivery continuum, populations, 
levels of analysis and types of research.  However, the centers should 
focus thematically on areas in which there are significant gaps in 
knowledge and critical needs – where focused, collective, 
interdisciplinary efforts could make the greatest difference in 
reducing tobacco use and tobacco-related disease. It is incumbent upon 
investigators to articulate the gap areas. It is expected that the 
TTURCs will catalyze problem solving and lead to more rapid advances in 
knowledge than would be possible by depending on individual 
investigators working in relative isolation. TTURCs should contribute 
to understanding what works and what does not work and why.  Essential 
elements of the Centers consist of at least 3 theoretically strong 
research projects with an integrative theme, cores and plans for career 
development and use of developmental funds.  Centers may vary in their 
breadth or concentration across research foci (e.g., gene to individual 
to community to culture, etc).  Some may choose to be tightly 
organized; others may have a broad span.  Centers are encouraged to 
study interactions across research foci (e.g., the variation of 
cultural and individual variables and treatment response) when 
possible.  Research integrated across projects, where findings from one 
major project inform or complement those in another, is also strongly 
encouraged.  Disciplinary integration within a center, and within 
projects (again, where feasible) is encouraged – particularly with 
regard to combining perspectives that reflect innovation.  Finally, 
disciplinary diversity in a center must support the objectives of the 
science and not merely reflect the training of the scientist.

Priority Research Topics

The initial period of TTURC funding has demonstrated that 
transdisciplinary research not only works, but that it can lead to 
advances in science not possible with uni-disciplinary approaches.  The 
demonstration that transdisciplinary research can lead to unique 
scientific progress allows NIH to use this approach to address critical 
research questions needed to advance public health.  NIH has identified 
several priority areas for research.  These thematic areas, along with 
examples of specific research questions, are identified below:  

o  Adolescents & young adults: Recent advances have identified key 
factors – genetic, social and environmental – that contribute to the 
etiology of youth tobacco use.   Yet, key research questions remain:  
Are there critical social or environmental events that together with a 
genetic predisposition to nicotine addiction increase or decrease the 
likelihood that young tobacco users will become addicted?   And, if we 
can identify those at greatest genetic risk, are there pharmacological 
(e.g. vaccine) or social (e.g. counter-advertising) interventions that 
can prevent tobacco use from progressing to addiction?

o  Women (Gender differences):  Some clinical studies have suggested 
that women have more difficulty quitting than men, suggesting that 
there may be  broader gender differences in the nature of nicotine 
addiction.  Important research questions include the nature of 
genetic/biologic factors that interact with gender in explaining 
treatment response, whether treatment impacts be improved by addressing 
social and cultural variables, and the salience of gene-hormone-
environment interactions in gender differences in tobacco use and 
cancer susceptibility. The other broad issue that relates to women is 
smoking during pregnancy, and the consequences for fetal and post-natal 

o  Psychiatric comorbidity:  Tobacco use is higher and cessation rates 
are lower among some psychiatric populations (e.g., depression, 
schizophrenia).  What are their common pathways?  How does tobacco use, 
treatment and cessation affect psychiatric symptomotology?  Is it 
possible to effectively treat tobacco dependence when psychiatric 
conditions have not been addressed?

o  Concurrent Tobacco and Alcohol  Abuse/Dependence:  The high 
comorbidity between alcohol and tobacco abuse/dependence  presents 
health risks over and above the risks posed by smoking or alcohol 
consumption alone.  What are the mechanisms underlying the conjoint use 
of these substances and how might the understanding of this linkage at 
the molecular, genetic, pharmacokinetic and behavioral levels inform 
the development effective treatments for concurrent use?

o  Disparities:  There are disproportionate rates of smoking among 
those of low income, less education, American Indian/Alaskan Natives, 
Southeast Asians, the unemployed, and particular categories of workers 
(e.g. blue collar, service workers, and farm workers).  How do social 
contextual (e.g. social networks, social ties, discrimination, 
historical factors) variables contribute to these disparities?  And how 
do social context factors interact with genetic, biological factors, 
chemical exposures, type of tobacco product (especially new products), 
and brand (i.e. menthol)?  Finally, in what ways might individual, 
quit-line, health care system-based treatments of tobacco dependence be 
improved to address disparities? 

o  Treatment development:  Treatments of smoking over the past decade 
have yielded successes but there is substantial room for improvement in 
outcomes.   How might understanding of the relationship between 
negative emotions and cognitive processing translate to the development 
of novel smoking cessation interventions?  Are there behavioral, health 
care system, or policy approaches that can be developed that will 
increase the use and effectiveness of existing smoking treatments so 
that cessation is more likely?

o  Treatment Delivery:  There is a need to understand how to improve 
treatment delivery.  Components of this might include enhancement of 
treatment-seeking behavior, health systems augmentations that would 
facilitate entry to and compensation for treatment services, and system 
integration that would allow logical and effective cohesion between 
various extant elements, such as quit lines, primary treatment 
providers, etc.  How might the development of technological devices 
(e.g., personal digital assistants, virtual reality) be used in the 
delivery of treatments?  Population-based approaches (i.e., defined 
populations) are particularly encouraged.

o  Genetic influences on nicotine dependence:  There is consensus that 
nicotine addiction is a result of a gene-environment interaction, yet 
far more research is needed on which gene variants are critical for the 
development and maintenance of addiction.   Are there multiple gene 
patterns that increase the likelihood of nicotine addiction, or perhaps 
specific gene variants that can be triggered by pharmacologic agents 
that will decrease the likelihood of becoming dependent?   And is it 
possible to tailor specific behavioral or pharmacological treatments 
for a specific genotype?  Understanding the patterns of tobacco use 
behavior and the relationship between tobacco use and use of other 
drugs may help us identify unique phenotypes or endophenotypes for 
genetic analyses.

o  Medication Development:  There is a need for new medications to 
treat various aspects of tobacco addiction, such as the reinforcing 
effects of nicotine and early relapse.  One broad approach would be to 
develop and validate new nicotine delivery systems to mimic the rapid 
delivery of nicotine produced by the inhalation of tobacco smoke, but 
with much reduced toxicity.  Another promising approach would exploit 
the maturing neuroscience of tobacco addiction, including the discovery 
of new neurochemical systems and molecular targets in addiction, 
withdrawal and relapse, and our increasing knowledge of the prominent 
conditioned effects that play a role in tobacco addiction.  

This RFA will use NIH center grant (P50) award mechanism.  Applicants 
will be solely responsible for planning, directing, and executing the 
proposed project.  This RFA is a one-time solicitation.  The 
anticipated award date is September 2004.  Although support of this 
program is through the specialized center (P50) grant mechanism, it is 
not a SPORE.  This mechanism supports the full range of research and 
development from basic to clinical and intervention studies.  The 
spectrum of activities comprises a transdisciplinary approach on a 
specific disease entity or biomedical problem.   These grants differ 
from traditional program project grants in that they are more complex 
and flexible in terms of the activities that can be supported.   In 
addition to support for transdisciplinary research projects, support is 
also provided for pilot research projects, specialized resources, 
career development programs, and shared core facilities.  Applicants 
will be responsible for the planning, direction, and execution of the 
proposed TTURC program.  Awards will be administered under NIH grants 
policy as stated in the NIH Grants Policy Statement. 

This RFA uses just-in-time concepts.  It also uses the non-modular 
budgeting formats (see  Follow the 
instructions for non-modular budget research grant applications.  This 
program does not require cost sharing as defined in the current NIH 
Grants Policy Statement at

Eight to nine new and/or competitive continuation grants are expected 
to be funded in response to this RFA.  The NCI intends to commit 
approximately $9 million in FY 2004 to fund the initial year.  The NIDA 
intends to commit $4.3 million for the initial year's funding.  The 
NIAAA intends to commit $1.5 million for the initial year's funding.  
An applicant may request a project period of up to 5 years and a budget 
for direct costs of up to $1.25 million in the initial year (excluding 
Facility and Administrative costs to consortium participants).  Future 
year increments are limited to 3%.  The budget for total costs cannot 
exceed $1.75 million for the initial 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 NCI/NIDA/NIAAA 
provide support for this program, awards pursuant to this RFA are 
contingent upon the availability of funds and the receipt of a 
sufficient number of meritorious applications. 
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 Domestic institutions/organizations. Applicants are encouraged to 
work with faith-based and community-based institutions.
o Foreign institutions are not eligible to apply.  However, domestic 
applications with foreign components are permitted.


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.   


The Centers must include three or more individual research projects, 
which reflect hypothesis-driven research, plus pilot or developmental 
research projects, shared resources (cores) and career development. 
Centers must provide clear evidence of a transdisciplinary focus, 
including an explanation of how the projects fit together across 
disciplines to promote synergy and syntheses. Evidence of plans and 
mechanisms for dissemination of research findings and products, 
including evidence-based tools and interventions must be stated.

Interactions among TTURCs are an important part of this initiative. 
Centers must identify creative strategies to foster formal and informal 
intra- and inter-center collaborations to identify and address 
overarching scientific and methodological issues. This may be in the 
form of research collaborations, visiting scientist, special issue 
working groups, exchange of data, resources and materials, and other 
mechanisms.  A requirement for all TTURC Principal Investigators and 
selected project investigators is participation in two meetings per year 
in the Washington, DC metropolitan area or other mutually convenient 
location.   One meeting will be smaller, with only the center directors 
and NIH staff and consultants in attendance.  At least three project 
staff should be budgeted for the larger meeting. Support for this travel 
should be included in the budget. The purpose of these meetings is to 
share scientific information, assess scientific progress, solve 
problems, identify new research opportunities, and establish priorities 
that will accelerate the translation of basic research findings to 
applied settings in patients and populations. Novel opportunities to 
facilitate collaboration also will be developed.  TTURCs will also be 
required (i) to use common measures that will allow pooling of data and 
(ii) to participate in evaluation activities.  Broad disciplinary 
representation in centers is expected.

TTURC Program Requirements

The following information must be provided in the application:

o A minimum of three fully developed R01-type research projects; 

o Evidence of a transdisciplinary focus, including an explanation of how 
the projects fit together across disciplines to promote synergy and 

o Shared administrative, technical, statistical, and other resources 
that can be justified; 

o Demonstration of a consistent and significant commitment to a career 
development program in tobacco control research. This may focus on 
graduate students, post-doctoral candidates, junior faculty, or 
established investigators who wish to develop or refocus their careers 
on tobacco control research. The description of this program should 
include the policies, criteria, and processes for selecting candidates, 
and must include special efforts to recruit qualified women and 
minorities. The plan should include the number and types of positions 
that will be made available, the criteria for eligibility and selection 
of candidates, and a description of the selection process. The plan 
should not include stipends and trainee costs though salary support for 
career development candidates may be requested; 

o A proposed process for funding developmental and pilot research to 
facilitate new collaborations and support the exploration of new ideas 
and methods. The interest here is in the process of solicitation and 
selection of the pilot projects rather than on the pilot projects 
itself.  It is important that TTURCs use pilot funds to stimulate 
projects that take maximum advantage of new research opportunities. Such 
projects may be collaborative among scientists within one or more 
TTURCs, or with scientists outside the TTURC environment. The TTURC 
application should propose and describe an institutional review process 
that selects pilot projects for center funding that represent the most 
innovative and transdisciplinary ideas. Applicants may supply a short 
description (2 pages maximum per project) of up to two eligible projects 
as examples. 

o Creative strategies to foster formal and informal intra- and inter-
center collaborations to identify and address overarching conceptual 
and methodological issues;  

o Evidence of plans and mechanisms for the dissemination of research 
findings and products, including evidence-based tools and 

All clinical trials supported or performed by NIH require some form of 
monitoring. The method and degree of monitoring should be commensurate 
with the degree of risk involved in participation and the size and 
complexity of the clinical trial. Monitoring exists on a continuum from 
monitoring by the principal investigator/project manager or NIH program 
staff to a Data and Safety Monitoring Board (DSMB). These monitoring 
activities are distinct from the requirement for study review and 
approval by an Institutional Review Board (IRB). For details about the 
Policy of the Data and Safety Monitoring of Clinical Trials see

Applicants are strongly discouraged from naming individual members of  
"advisory committees" or "scientific boards" until after receipt of an 


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:

o Direct your questions about scientific/research issues to:

Glen D. Morgan, Ph.D.   
Tobacco Control Research Branch  
Behavioral Research Program  
Division of Cancer Control and Population Sciences  
National Cancer Institute  
Executive Plaza North, Rm. 4034  
6130 Executive Blvd., MSC 7337  
Bethesda, MD  20892-7337
Telephone: 301-496-8585  

Allison Chausmer, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Blvd, Rm. 4282, MSC 9555
Bethesda, MD  20892-9555
Telephone:  (301) 402-5088

Joanne B. Fertig, Ph.D.
Treatment Research Branch
Division of Clinical and Prevention Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Blvd, Suite 505Bethesda, MD 20892-7003
Telephone:  (301) 443-0635

o Direct your questions about peer review issues to:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Telephone: (301) 496-3428
FAX: (301) 402-0275 

o Direct your questions about financial or grants management matters 

Ms. Crystal Wolfrey
Grants Administration Branch
National Cancer Institute
6120 Executive Boulevard, Suite 243
Bethesda, MD  20892-7340
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-8634
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 NCI 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:

Glen D. Morgan, Ph.D.  
Tobacco Control Research Branch  
Behavioral Research Program  
Division of Cancer Control and Population Sciences  
National Cancer Institute  
Executive Plaza North, Rm. 4034  
6130 Executive Blvd., MSC 7337  
Bethesda, MD  20892-7337
Telephone: 301-496-8585  


The NCI/NIDA/NIAAA will hold a pre-application meeting through a 
videoconference to which all prospective applicants are invited. 
Program staff & staff from the Division of Extramural Activities (DEA) 
will make presentations that explain their goals and objectives for the 
Transdisciplinary Tobacco Use Research Centers and answer questions 
from the attendees. Prospective applicants are urged to monitor the NIH 
Guide Notice for the date and time of the meeting at


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 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 in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:
SUPPLEMENTARY INSTRUCTIONS:  Additional instructions for preparing a 
TTURC grant application are available from the program staff listed 
under INQUIRIES and can also be found at the following URL link:  The instructions must be 
requested and used in preparing a TTURC application.  
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:
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:

Referral Officer
National Cancer Institute
Division of Extramural Activities
6116 Executive Boulevard, Room 8041, MSC 8329
Bethesda, MD 20892-8329
Rockville, MD  20852 (for express/courier service)

INSTITUTE WILL NO LONGER BE ACCEPTED.  This policy does not apply to 
courier deliveries (i.e. FEDEX, UPS, DHL, etc.) 
This change in practice is effective immediately.  This policy is 
similar to and consistent with the policy for applications addressed to 
Centers for Scientific Review as published in the NIH Guide Notice

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 unfunded 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.  

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NCI.  Incomplete and/or nonresponsive 
applications will not be reviewed. 

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 Division of Extramural Activities of the 
NCI 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 appropriate National Advisory 
Council or Board.

Competitive applications will reflect more than an interesting 
collection of projects. It is critical that there be evidence of the 
potential for a meaningful center with a real theme and identity. 

The Centers must include three or more individual research projects, 
which reflect hypothesis-driven research, plus a process for pilot or 
developmental research projects, shared resources (cores) and career 
development. The Center and the projects should result in the generation 
of new knowledge in tobacco control and/or nicotine addiction science. 
Reviewers will evaluate each center using the criteria listed below.  
Each criterion will be addressed and considered by the reviewers in 
assigning the overall score for project merit:


1.  Significance.  The importance of the research objective to tobacco 
control research and its likelihood of completion within the project 

2.  Approach.  The adequacy of the experimental design and methods to 
achieve the research objectives. Are the theoretical framework, design, 
methods, and analyses adequately developed, well integrated, and 
appropriate to the aims of the project?  Does the applicant acknowledge 
potential problem areas and consider alternative transdisciplinary 

3.  Innovation.  Originality and novelty of the experimental design as 
it relates to tobacco control theory and research. Does the project 
develop new methodologies or technologies in tobacco control research? 
Does the research design reflect sufficient originality, novelty, and 
innovation to make it highly relevant to the overall goals and 
objectives of the TTURC?

4.  Investigators.  The qualifications of investigators to conduct the 
proposed research and the appropriateness of the time commitments of 
each member of the team to the conduct of the project. Is the proposed 
work appropriate to the experience level of the Principal Investigator 
and project researchers?   

5.  Environment. The scientific environment in which the research work 
will be done, and the unique features, if any, of the environment to 
support the proposed work. Does the scientific environment in which the 
work will be done contribute to the probability of success? Do the 
proposed projects take advantage of unique and transdisciplinary 
features in the scientific environment and reach out to useful 
collaborative arrangements? Is there evidence of adequate institutional 
support? Is the project interactive with other components of the TTURC, 
conceptually, experimentally, and translationally?

6. Transdisciplinary Collaboration. Is there evidence of significant 
transdisciplinary basic, clinical and public health interactions in the 
conception, design, and proposed implementation of the project? Is the 
proposed research informed by the breadth of relevant scientific 
literature from multiple disciplines in the social, behavioral, and 
biological sciences? 


1. adequacy of the justification for each specialized resource relative 
to its essential need for the conduct of TTURC research or pilot 
projects and TTURC collaborative projects.

2. adequacy of qualifications and performance (if applicable) of 
managers of resources to conduct high quality, reliable resource 

3. adequacy of plans for oversight of resources and the prioritization 
of work


1. adequacy of the process and/or track record for selecting candidates 
for career development who demonstrate potential for independent 
research careers in transdisciplinary cancer tobacco control – related 
research or who are established investigators and are changing the 
direction of their research careers; cross-disciplinary training should 
enable scientists to bridge scientific domains in tobacco control 
research, to foster important integrative scientific inquiry;

2. adequacy of the procedures and/or track record to seek out and 
include qualified minorities, women, and persons with disabilities in 
the career development program; 

3. adequacy of the individuals available in the program to serve as 
possible mentors of career development candidates; the current 
availability and adequacy of projects for career development candidates;

4. complementary activities that contribute to the environment for 
career development;

5. capacity of the overall program to absorb career development 
candidates and prepare them for independent transdisciplinary tobacco 
control research careers.


1. adequacy of the process and/or track record for attracting new ideas 
for pilot studies within the TTURC.

2. adequacy of the proposed process and/or track record for continuously 
reviewing and funding a spectrum of pilot projects (e.g., research, 
technology development, resources) for their quality, innovativeness, 
transdisciplinary nature and importance to translational research that 
will have an impact on enhancing tobacco control efforts and developing 
innovative new intervention and prevention programs.

3. general quality of the pilot projects described in the application to 
demonstrate the effectiveness of the process for selecting pilot 
projects funding;

4. degree to which developmental funds will be used to stimulate pilot 
projects with transdisciplinary interactions and/or collaborative 
interactions with other scientists within or outside of the parent 
institution, and especially with other NCI/NIDA/NIAAA-funded centers and 


1. scientific qualifications and involvement of the Principal 
Investigator, as well as his/her demonstrated scientific and 
administrative leadership capabilities; adequacy of the time commitment 
of the Principal Investigator;

2. transdisciplinary nature of the proposed research activities, 
integration of the projects around an overarching theme, and plans to 
effectively pursue transdisciplinary research objectives;

3. adequacy of access to patients and populations for conducting current 
and projected research;

4. adequacy of the procedures, processes, and plans for promoting 
transdisciplinary interactions, including coordination, interaction, 
collaboration and synthesis;

5. facilitation of technology transfer; management of the intellectual 
property rights of the TTURC under the requirements of the Bayh-Dole Act 
and NIH funding agreements;

6. written assurance that TTURC interactions with commercial entities 
will uphold the principles of academic freedom, including the ability of 
TTURC investigators to collaborate freely, and to send and receive 
research materials without restriction to other scientific researchers;

7.  adequacy of plans to promote and maintain communication and 
integration of scientific projects of mutual interest with other TTURCs;

8.  willingness to interact with other TTURCs and with the NIH in 
sharing information, in assessing scientific progress, in identifying 
new research opportunities and in establishing  scientific priorities.


1. adequacy of facilities, equipment and space to promote 
transdisciplinary and translational research objectives;

2. adequacy of institutional procedures and plans for monitoring, 
evaluating, and assuming accountability for the general success of the 

3. adequacy of the institutional infrastructure for assessing progress 
and needs. 

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:

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).
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).

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.  


Sharing Research Data:  Applicants requesting more than $500,000 in 
direct costs in any year of the proposed research must include a data 
sharing plan in their application. The reasonableness of the data 
sharing plan or the rationale for not sharing research data will be 
assessed by the reviewers. However, reviewers will not factor the 
proposed data sharing plan into the determination of scientific merit 
or priority score.  (See url in Federal Citations, below.)

BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research, core resource 
operations, developmental research program, and career development.  
Salary support for career development candidates maybe included.  
However, stipends and trainee costs are not allowable.


A single numerical priority score will be assigned to the TTURC 
application as a whole after discussing all of the review elements 
listed above.  The score will be based on the overall quality of the 
research projects, the career development program and the developmental 
research program, the overall effectiveness and adequacy of shared 
resources, the overall program organization and capability, and the 
plans for interactions with other TTURCs. 

Although primary emphasis will be placed on scientific merit, 
significant consideration will also be given to transdisciplinary 
interactions, potential for impacting on the disease, inter-Center 
collaborations and institutional commitment.


Letter of Intent Receipt Date:  December 26, 2003
Application Receipt Date:  January 23, 2004
Peer Review Date:  June, 2004
Council Review:  September, 2004
Earliest Anticipated Start Date:  September, 2004


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

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:  

Clinical trials supported or performed by NIH require special 
considerations.  The method and degree of monitoring should be 
commensurate with the degree of risk involved in participation and the 
size and complexity of the clinical trial.  Monitoring exists on a 
continuum from monitoring by the principal investigator/project manager 
or NIH program staff or a Data and Safety Monitoring Board (DSMB).  
These monitoring activities are distinct from the requirement for study 
review and approval by an Institutional review Board (IRB).  For 
details about the Policy for Data and Safety Monitoring of Clinical 
trials see:  
For Phase I and II clinical trials, investigators must submit a general 
description of the data and safety monitoring plan as part of the 
research application.  See NIH Guide Notice on "Further Guidance on a 
Data and Safety Monitoring for Phase I and II Trials" for additional 
Information concerning essential elements of data safety 
monitoring plans for clinical trials is available:

SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000 
or more in direct costs in any single year are expected to include a 
plan for data sharing or state why this is not possible.  Investigators should 
seek guidance from their institutions, on issues related to 
institutional policies, local IRB rules, as well as local, state and 
Federal laws and regulations, including the Privacy Rule. Reviewers 
will consider the data sharing plan but will not factor the plan into 
the determination of the scientific merit or the priority score.

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 

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 

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, 

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  
A continuing education program in the protection of human participants 
in research is available online 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 review. 

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

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.

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 
( 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

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 

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

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.


Centers for Disease Control and Prevention, Cigarette smoking among 
adults--United States, 1997. MMWR Morb Mortal Wkly Rep, 1999. 48(43): 
p. 993-6. 

Engstrom PE, C.M., Schnoll RA, et al, Prevention of tobacco-related 
cancers, in Cancer Medicine, F.E. Hollan JF, Editor. 2000, BC Decker: 
Hamilton, Ontario, Canada. p. 127-140.

Fiore, M.C., et al., Treating Tobacco Use and Dependence. Clinical 
Practice Guideline. 2000, Rockville, MD: U.S. Department of Health and 
Human Services. 

Henningfield, J.E., C. Cohen, and J.D. Slade, Is nicotine more 
addictive than cocaine? Br J Addict, 1991. 86(5): p. 565-9.
Johnston LD, O.M.P., Bachman JG., National Survey Results on Drug use 
from the Monitoring the Future Study, 1975-1993, ed. USDHHS. Vol. 1 and 
2. 1994, Rockville, MD: NIH Publication 94-3810. 

Johnston LD, O.M.P., Bachman JG., Teen smoking declines sharply in 
2002, more than offsetting large increases in the early 1990s. 
University of Michigan News and Information Services: Ann Arbor, MI, 

McNeill, A.D., The development of dependence on smoking in children. Br 
J Addict, 1991. 86(5): p. 589-92. 

Morgan GD, F.P., Matthews E, Leischow S, Smoking cessation. Progress in 
Oncology, ed. H.S. DeVita V, Rosenberg S. 2002, Sunbury, MA: Jones & 
Bartlett. 294-312.
National Cancer Institute, Changing Adolescent Smoking Prevalence. 
Smoking and Tobacco Control Monograph. Vol. 14. 2001, Bethesda, MD.

National Cancer Institute, The Nation's Investment in Cancer Research. 
A Plan and Budget Proposal for Fiscal Year 2002. 2000. 

Peto, R., et al., Mortality from tobacco in developed countries: 
indirect estimation from national vital statistics. Lancet, 1992. 
339(8804): p. 1268-78. 

Proceedings from "New Partnerships and Paradigms for Tobacco Prevention 
Research". 1999: Nicotine Tob Res.

Report from the working groups of the Youth Tobacco Prevention 
Initiative. Youth Tobacco Prevention Initiative. 1998, Washington, DC: 
Center for Advancement of Health. 

Rosenfield, P.L., The potential of transdisciplinary research for 
sustaining and extending linkages between the health and social 
sciences. Soc Sci Med, 1992. 35(11): p. 1343-57. 
Tobacco Research Implementation Group, The National Cancer Institute: 
Tobacco Research Implementation Plan: Priorities for Tobacco Research 
Beyond the Year 2000. 1998. 

Turkkan, J.S., N.J. Kaufman, and B.K. Rimer, Transdisciplinary tobacco 
use research centers: a model collaboration between public and private 
sectors. Nicotine Tob Res, 2000. 2(1): p. 9-13. 

U.S. Department of Health and Human Services, Reducing Tobacco Use. A 
report from the Surgeon General. 2000: USDHHS, CDC, National Center for 
Chronic Disease Prevention & Health Promotion, Office of Smoking & 

World Health Organization, The tobacco epidemic: a global public health 
emergency. Tobacco Alert, 1998.

Wynder, E.L., The past, present, and future of the prevention of lung 
cancer. Cancer Epidemiol Biomarkers Prev, 1998. 7(9): p. 735-48.

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