STATE MODELS FOR ORAL CANCER PREVENTION AND EARLY DETECTION

Release Date:  June 22, 2000

RFA:  DE-00-005

National Institute of Dental and Craniofacial Research
 (http://www.nidcr.nih.gov/)
National Cancer Institute
 (http://www.nci.nih.gov/)

Letter of Intent Receipt Date:  December 15, 2000
Application Receipt Date:       February 16, 2001

THIS RFA USES THE “MODULAR GRANT” AND “JUST-IN-TIME” CONCEPTS.  IT INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING APLICATIONS IN RESPONSE TO THIS RFA

PURPOSE

The National Institute of Dental and Craniofacial Research (NIDCR) and the 
National Cancer Institute (NCI) invite applications from eligible 
institutions for grants to aid in research leading to the development of 
state models for oral cancer prevention and early detection programs. This 
initiative is viewed as a first step in the use of oral health assessments as 
part of an evaluation of overall systemic health.  The aims of the current 
initiative are to:  (a) support an epidemiological assessment of the level of 
oral cancer  within the state; (b) assess level of knowledge of oral cancer 
risk factors among health professions (e.g., dentistry, medicine, pharmacy, 
nursing, dental hygiene, physician assistants and health educators) and the 
public; (c) document and assess practices in diagnosing oral cancers in 
health professions; and (d) assess whether or not the public is receiving an 
oral cancer examination annually from a healthcare provider.  A statewide 
assessment, as opposed to any other approach, is key because each state has 
particular demographics, oral cancer epidemiology and practice acts governing 
health professions.  Also, differences exist among state health departments, 
state cancer control programs, policies regarding use of tobacco settlement 
dollars and awareness of oral cancer prevention and early detection by the 
public and health professionals. The three-year grant is expected to be used 
in leading to the development of an organizational infrastructure and a plan 
of action necessary for designing and implementing future interventions to 
prevent and reduce oral cancer morbidity and mortality.  It is the intention 
of the NIDCR and the NCI to issue a subsequent Request for Application (RFA) 
to support the development, implementation and evaluation of interventions 
promoting oral cancer awareness, prevention and early detection.  Specific 
response to this RFA will require information obtained during the three-year 
developmental period.

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 Request for 
Application (RFA), State Models for Oral Cancer Prevention and Early 
Detection, is related to three or more of the priority areas.  Potential 
applicants may obtain more information about Healthy People 2010 at 
http://www.health.gov/healthypeople/.

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic for-profit and non-profit 
organizations, public and private, such as colleges, universities, units of 
state and local governments and eligible agencies of the federal government.  
Foreign organizations are not eligible and domestic organizations may not 
include international components.  Collaborative applications among eligible 
domestic organizations are encouraged.  Among collaborators, one must be 
designated as the lead applicant and assume administrative and scientific 
responsibility for the project.  Racial/ethnic minority individuals, women, 
and persons with disabilities are encouraged to apply as principal 
investigators (PI).

MECHANISM OF SUPPORT

The mechanism of support utilized will be an Exploratory/Developmental Grant 
(R21).  Responsibility for the planning, direction, and execution of the 
proposed project will be solely that of the applicant and collaborating 
institutions.  However, consultation with NIDCR and/or NCI staff will be 
expected and a meeting with the principal investigator, key personal and 
NIDCR and NCI staff will be scheduled each year after initial funding.

The total project period may not exceed three years.   This RFA is a one-time 
solicitation, and grants funded through it may not be renewed or extended.  
The earliest possible date for funding of the R21 applications is July 2001.  
It is anticipated that a second RFA will be issued in 2003 for competition 
among those institutions receiving support as part of the current RFA as well 
as states that have completed Phase I using funds provided by other sources. 
Depending on the availability of funds and scientifically meritorious 
applications, we plan to fund up to 10 of the Phase II applications.

Specific application instructions have been modified to reflect "MODULAR 
GRANT" and "JUST-IN-TIME" application procedures. Complete and detailed 
instructions and information on Modular Grant applications can be found at 
http://grants.nih.gov/grants/funding/modular/modular.htm and in the NIH Guide 
for Grants and Contracts, December 15, 1998 
(http://grants.nih.gov/grants/guide/notice-files/not98-178.html).

FUNDS AVAILABLE

It is expected that up to $2.0 million per year will be allocated in support 
of the developmental grants.  The NIDCR and NCI plan to fund up to 13 grants, 
providing sufficient numbers of highly scientifically meritorious 
applications are received and provided that sufficient funds are available. 
Each request may not exceed $100,000 direct costs for each of the three-
years.  All applications must include costs for travel to one meeting per 
year in Bethesda for the principal investigator and key personnel.  
Applicants are reminded that that other sources of funding maybe available to 
augment these activities. 

RESEARCH OBJECTIVES

Dental and craniofacial diseases and disorders are among the most common 
health problems affecting the people of the United States.  The burden 
imposed by a variety of dental and craniofacial diseases and disorders range 
from birth defects such as cleft lip and palate, which occurs in every 1 in 
525 to 714 live births, to injuries to the head and face, resulting in nearly 
20 million emergency room visits per year, to devastating head and neck 
cancers of which oral and pharyngeal cancers account for 8,000 deaths per 
year and more than 30,000 new cases per year.  The treatment of over 1.2 
million cancer patients each year can lead to complications such as painful 
mouth ulcers, mucositis, rampant dental caries, fungal infections, impaired 
taste and loss of function of the salivary glands.  Oral infections still 
remain common in our populations.  Dental caries is experienced by 45% of 
elementary aged school children and 94% of adults have experienced this 
infection at some point in life.  Periodontal infections occur in 90% of 
individuals older than 13 years and may be associated with other systemic 
diseases or conditions such as diabetes, cardiovascular disease, respiratory 
infections, and pre-term/low birth weight babies. Orofacial pain is likely to 
have been experienced by over 20% of adults in the past six months, is a 
major component of temporomandibular joint diseases (TMD) for at least 6% of 
adults, and is a major component of Bell's palsy, trigeminal neuralgia and 
fibromyalgia.  Salivary gland dysfunction in the form of Sjogren’s syndrome 
affects between 1 and 4 million Americans while over 30,000 individuals who 
have cystic fibrosis are also at higher risk for concomitant salivary gland 
dysfunction. Further, over 500 prescription drugs have xerostomic (dry mouth) 
side effects, increasing the risk for both bacterial and fungal oral 
infections as well as other oral conditions.  Oral candidiasis is commonly 
found in HIV-infected patients. 

From a public health perspective, it is not only important to understand the 
etiology, pathogenesis, treatment and prevention of oral diseases and 
conditions per se but it is also clear that such an understanding can play a 
central role in the understanding, treatment and prevention of other systemic 
diseases and conditions and vice versa.  On the one hand, oral assessments 
can provide convenient and important biomarkers for systemic disease as well 
as information about the oral health status of the individual.  Further, in 
order to develop an understanding of overall health and/or disease it is 
imperative to understand oral health and/or diseases since without oral 
health the individual cannot be considered to be healthy. While the present 
initiative addresses one aspect of this global approach to understanding 
health and disease, it is consistent with this initiative to view oral 
assessment as integral to a broader understanding of health and disease.  Our 
interest here is in the early detection and identification of oral and 
pharyngeal cancer (i.e., cancers of the oral cavity and pharynx).  While our 
focus is on these aspects of the anatomy, it would also be appropriate to 
include within the scope of this initiative head and neck cancers as long as 
they also included oral and pharyngeal cancers.     

Background

In 1999 it was estimated that oral and pharyngeal cancers would account for 
29,800 cases and 8,100 deaths in the United States (Landis, Murray et al. 
1999).  More than 90% of oral cancers occur in individuals 45 years of age 
and over (Ries, Kosary et al. 1999).  Although males are more likely than 
females to develop these cancers, the male to female ratio decreased form 6:1 
in 1950 to 2:1 in 1987 and this ratio has remained constant to the present 
(Horowitz, Goodman et al., 1996; Ries, Kosary et al. 1999).  The age-adjusted 
incidence rate for total oral cavity and pharynx cancers was 10.0 per 100,000 
population in 1996 (Ries, Kosary et al. 1999).  While these cancers represent 
3% of all cancers in the United States they have one of the lowest five-year 
survival rates of any of the major cancer sites.  Their overall five-year 
survival rate is 53% and it has not changed in the past thirty years (Swango 
1996).  These low survival rates may be attributed to the fact that these 
cancers tend to be diagnosed at advanced stages.  Moreover, these cancers and 
the regimen utilized for their treatment are extremely disfiguring and often 
result in severe loss of function including inability to swallow and 
impairment of speech. 

The major risk factors for oral cancers in the United States are use of 
tobacco and alcohol.  The use of these two products account for 75% of all 
oral cancers (Wynder, Mushinski et al. 1977).  A recent case-control study 
suggests that marijuana use may increase the risk for head and neck cancer 
(Zhang, Morgenstern et al. 1999). Lip cancer, on the other hand, is primarily 
associated with sun exposure.  Other risk factors for oral cancers include 
malnutrition or poor dietary intake of essential minerals.  For example, 
Plummer-Vinson syndrome, an iron deficiency, may place women at risk of oral 
cancers (Horowitz, Goodman et al. 1996; Devesa, Blot et. al. 1990).  Other 
risk factors include exposure to viruses such as human papillomavirus 
(Gillison, Koch et al. 1999) and Epstein-Barr virus (Yu MC 1996).  An 
increased consumption of fruits and vegetables is associated with lower risk 
of oral cancers (Potter, Chavez et al. 1997). Thus, primary prevention 
measures include: 1) avoiding tobacco products, 2) limiting the intake of 
alcoholic beverages, 3) eating a diet rich in fruit and vegetables and 4) 
avoiding exposure to certain viruses and sunlight.  

A visual and tactile examination of the oral cavity is essential for early 
detection.  Because of the significant morbidity and mortality associated 
with the diagnosis of oral cancer at advance stages, the American Cancer 
Society (ACS) recommends an oral cancer examination every 3 years for 
individuals over age 20 and annually for persons 40 years of age or older 
(Update January 1992; Horowitz, Goodman et al. 1996).  The U.S. Prevention 
Services Task Force recommends that clinicians include a careful examination 
for oral cancer in asymptomatic individuals who use tobacco or alcohol 
(DiGuiseppi, Atkins et al. 1996).  An oral cancer examination poses little 
discomfort for the patient and is noninvasive. Although dentists and dental 
hygienists generally perform this type of examination, other health care 
providers  (i.e., nurse practitioners, physician assistants, physicians) 
should provide an oral cancer examination as part of a routine physical.  
Involvement of the latter health care providers is essential because many 
individuals in high-risk groups visit them more frequently than a dentist or 
dental hygienist.  

A national survey of US dentists’ knowledge and opinions concerning oral 
cancers indicated that the majority of dentists identified most of the real 
risk factors for oral and pharyngeal cancers (i.e., tobacco, age, prior 
cancer) while only 33% knew that oral cancers are most often diagnosed in 
late stages (Yellowitz JA, Horowitz AM, Drury TF, Goodman HS, A survey of US 
dentists’ knowledge and opinions about oral cancer, in press).   Recent 
graduates of dentistry were found to be better informed.  The results of the 
national survey of dental hygienists were similar to the national survey of 
dentists regarding knowledge of the major risk factors for oral and 
pharyngeal cancers.  However, some deficiencies were identified regarding 
oral cancer diagnostic procedures among dentists and dental hygienists.  Some 
did not feel adequately trained to perform an oral cancer examination, nor to 
palpate lymph nodes (Abstract, APHA meeting, Chicago, November, 1999). 

These national surveys also addressed the age group of patients receiving an 
oral cancer examination and included questions on oral cancer risk factors 
assessed by the health provider when obtaining the patient’s medical history.   
Eighty-eight percent of dentists indicated they did not provide an oral 
cancer examination for edentulous patients 18 years of age or older and 81% 
provided an oral cancer examination to all their patients above 40 years of 
age in the initial appointment (Horowitz AM, Drury TF, Goodman HS, Yellowitz 
JA, Dentists’ practices and opinions regarding oral cancer prevention and 
early detection, in press).  In regards to oral cancer risk factors, current 
use of tobacco products was a question consistently asked by dentists and 
dental hygienists.  Only 75% of dentists asked about past use of tobacco 
products and 70% asked about types and amount of tobacco products used.  In 
addition, less than 50% of oral health professionals inquired about current 
and past use of alcohol products (Abstract AAPHA, San Francisco, October, 
1998).  

The 1990 National Health Interview Survey (NHIS), Health Promotion and 
Disease Prevention Supplement (HPDP,) included four questions about oral 
cancers.  This study revealed that the US adult public is not well informed 
about signs of oral cancers.  In addition, the 1992 National Center for 
Health Statistics (NCHS) Cancer Supplement Survey found that only 14% of the 
public had ever been examined for oral cancers and 7% in the past year. Lack 
of adequate knowledge by the general public (Horowitz, Nourjah et al. 1995) 
and veterans receiving services at the VA Maryland Health Care System (Canto, 
Horowitz et al. 1998) was partially explained by minimal coverage of oral 
cancers in popular magazines and newspapers, (Canto, Kawagushi et al. 1998) 
and limited availability of oral cancer educational materials designed for 
the public (Abstract IADR/AADR, Vancouver, Canada, March 1999).

Oral cancer awareness by the general public and health professionals may 
differ from one state to another.  The particular demographics of a state 
have an impact on the most relevant interventions and activities to reduce 
the burden from oral cancers.  In addition, state health professions practice 
acts will determine which group of allied health personnel can most 
effectively provide oral cancer examinations.  A state model approach for 
oral cancer prevention and early detection is recommended to reach a large 
segment of health professionals and the public including those groups at high 
risk. 

Project Design

The overall project must include a sound-planning framework embodying state-
of-the-science planning principles, approaches, and sequencing of program 
activities (including needs assessment, program design and initiation, 
implementation, evaluation, and sustainability).  The total project will 
consist of two phases: Phase I, the establishment of an organizational 
infrastructure and needs assessment to be funded for three years; Phase II, 
the development and pilot testing of educational interventions, and program 
evaluation to be funded for five years.  

It is the intent of the current RFA to support Phase I activities, which 
includes planning and development of an organizational infrastructure as well 
as the state needs assessment regarding oral cancer prevention and early 
detection.  The state needs assessment will consist of: (a) a review of 
epidemiological data (incidence, prevalence, mortality) of oral cancer; (b) a 
review of available resources for cancer prevention and control; (c) an 
assessment of cancer diagnosis by the various health professionals (i.e., 
frequency with which each profession diagnoses oral cancers as well as the 
stage at which oral cancers are diagnosed);  (d) a qualitative and 
quantitative assessment of health care provider’s and the general public’s 
oral cancer knowledge, opinions and practices about oral cancer prevention 
and early detection; and (e) an evaluation of the types of educational 
materials available to the public and health professionals in the state on 
oral cancers. 

The organizational infrastructure envisioned is a statewide partnership among 
groups and/or agencies interested in oral cancer prevention and early 
detection.  Members of the partnership shall include, at a minimum, the State 
Health Officer and/or Dental Director and an academic institution (i.e., 
universities with medical, dental, nursing or public health schools).  
Additional groups could include, but are not limited to, federal, state, and 
local governments, other schools and universities, religious organizations, 
consumer organization, businesses, child and youth agencies, American Cancer 
Society, and/or health care provider associations.  The partnership must 
identify a lead group or agency that would serve as the grantee institution, 
a leadership structure and operating procedures.  It is strongly recommended 
that an academic institution be the grantee institution.  A major aim of 
Phase I is the establishment of the partnership for oral cancer prevention in 
the state, which will direct the development and implementation of future 
activities well beyond the scope of this or subsequent RFAs.  

A member of an academic institution should be identified as “Research 
Director” and be responsible for research activities such as collection and 
analysis of epidemiological data, and the development and administration of 
surveys.  The “Research Director” also may be the application’s principal 
investigator if s/he is located at the grantee institution.  

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of the NIH that women and members of minority groups and 
their subpopulations must be included in all NIH supported biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification is provided 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 research involving human subjects should read the 
“NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research”, which was published in the Federal Register of March 28, 1994 (FR 
59 14508-14513) and in the NIH Guide for grants and Contracts, Vol. 23, No. 
11, March 18, 1994, available on the web at: 
http://grants.nih.gov/grants/guide/notice-files/not94-100.html.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 was published in the NIH Guide for Grants and Contracts, March 6, 1998, 
and is available at the following URL address: 
http://grants.nih.gov/grants/guide/notice-files/not98-024.html.  

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent no later than 
December 15, 2000 that includes a descriptive title of the proposed research, 
the name, address, email address if available and telephone number of the 
Principal Investigator, the identities of other key personnel and 
participating institutions, and the number and title of the RFA in response 
to which the application is submitted.  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 NIDCR and NCI staff to 
estimate the potential review workload and to plan the review.

The letter of intent is to be sent to Dr. Norman S. Braveman, the NIDCR 
program staff listed under INQUIRIES.
 
INFORMATIONAL CONFERENCE

An informational conference will be held on September 29, 2000 in Building 
31, Room 6C6, National Institutes of Health, Bethesda, Maryland from 8:30 
a.m. until 5 p.m. No pre-registration is necessary but it would be helpful to 
indicate your intention to attend by contacting Dr. Norman Braveman.  Contact 
information is listed under the section titled INQUIRIES.  The conference 
will address the scientific and administrative issues associated with this 
RFA.  Representatives from the NIDCR and the NCI will be available to provide 
information and to answer questions from potential applicants responding to 
this RFA.  Materials presented at the conference will be available for those 
unable to attend.

APPLICATION PROCEDURES

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The just-in-
time concept allows applicants to submit certain information only when there 
is a possibility for an award.  It is anticipated that these changes will 
reduce the administrative burden for the applicants, reviewers and Institute 
staff.  The research grant application form, PHS 398 (revised 4/98) is to be 
used in applying for these grants, with the modifications noted below.

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.  Reviewers are cautioned that their anonymity may 
be compromised when they directly access an Internet site.
 
BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up 
to a total of $100,000 direct costs for each of three-years.  The modular 
budget request must be in accordance with the modifications made to the 
standard PHS 398 application instructions described below:

PHS 398

FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in 
$25,000 increments) and Total Costs [Modular Total Direct plus Facilities and 
Administrative (F&A) costs] for the initial budget period.  Items 8a and 8b 
should be completed indicating the Direct and Total Costs for the entire 
proposed period of support.

DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD – Do not complete Form Page 4 
of the PHS 398.  It is not required and will not be accepted with the 
application.

BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT – Do not complete the 
categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

NARRATIVE BUDGET JUSTIFICATION – Prepare a Modular Grant Budget Narrative 
page.  (See http://grants.nih.gov/grants/funding/modular/modular.htm for 
sample pages).  At the top of the page, enter the total direct costs 
requested for each year.  This is not a Form page.

UNDER PERSONNEL – List key project personnel, including their names, percent 
of effort, and roles on the project.  No individual salary information should 
be provided.  However, the applicant should use the NIH appropriation 
language salary cap and the NIH policy for graduate student compensation in 
developing the budget request.

For Consortium/Contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the 
nearest $1,000.  List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of key personnel, 
and the role on the project. Indicate whether the collaborating institution 
is foreign or domestic.  The total cost for a consortium/contractual 
arrangement is included in the overall requested modular direct cost amount.  
Include a Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

BIOGRAPHICAL SKETCH – The biographical Sketch provides information used by 
reviewers in the assessment of each individual’s qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three 
pages may be used for each person.  A sample biographical sketch may be 
viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm
- Complete the educational block at the top of the form page;
- List position (s) and any honors;
- Provide information including overall goals and responsibilities, on 
research projects ongoing or completed during the last three years;
- List selected peer-reviewed publications, with full citations.

CHECKLIST – This page should be completed and submitted with the application.  
If the F&A rate agreement has been established, indicate the type of 
agreement and the date.  All appropriate exclusions must be applied in the 
calculation of the F&A costs for the initial budget period and all future 
budget years.

The application should provide the name and phone number if the individuals 
to contact concerning fiscal and administrative issues if additional 
information is necessary following the initial review.

The RFA label available in the PHS 398 (rev. 4/98) application form must be 
affixed to the bottom of the face page of the application.  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 (DE-00-005) must be typed on line 2 of the face page of the 
application form and the YES box must be marked.

The sample RFA label available at:
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf has been modified to 
allow for this change.  Please note this is in pdf format.

Submit a signed, typed written 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 (2) additional copies of the application must 
also be sent to:

Dr. H. George Hausch
Scientific Review Branch
Division of Extramural Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-38D, MSC 6402
Building, Room Number, MSC 6402
Bethesda, MD  20892-6402

Applications must be received by February 16, 2001.  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.

REVIEW CONSIDERATIONS

Upon receipt, applications will be reviewed for completeness by CSR and for 
responsiveness by NIDCR and NCI staff.  Incomplete and/or non-responsive 
applications will be returned to applicants without further considerations.

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 receive a written 
critique and 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, assigned a priority score, and receive a 
second level review by the National Advisory Dental and Craniofacial Research 
Council and the National Cancer Advisory Board.

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 the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application.  Note that the 
application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserve a high priority score.  For 
example, investigators may propose to carry out important work that by its 
nature is not innovative but is essential to move a field forward.

Listed below are the review criteria to be used in the evaluation of the 
applications: 

Significance: Does the project address geographical areas that exhibit an 
oral cancer burden? If aims of the project are accomplished, how will 
scientific knowledge be advanced? What will be the effect of the project on 
oral cancer prevention and early detection?    
 
Approach: Are the conceptual framework, design methods and analyses 
adequately developed, well integrated and appropriate to the aims of the 
project? Does the investigator acknowledge potential problems and consider 
alternative approaches? Does the approach provide a sound-planning framework? 
Is there a plan for developing the organizational infrastructure 
(partnership) for oral cancer prevention and early detection?  Is there an 
appropriate plan for collection and analysis of epidemiological data? Does it 
address relevant recommendations from the National Strategic Conference for 
the Prevention and Control of Oral and Pharyngeal Cancer held on August 7-9, 
1996? Is the proposed partnership likely to obtain and effectively utilize 
leveraged funding, such as tobacco settlement funds directed towards the 
reduction of oral cancer through tobacco cessation? 

Innovation: Does the project employ novel concepts, approaches or methods?

Investigator: Is the investigator appropriately trained and well suited to 
carry out the work? Is the work proposed appropriate to the experience level 
of the principal investigator and other researchers (if any) associated with 
the project? Has the investigator published in this area of research?

Environment: Does the scientific environment in which the work will be done 
contribute to the probability of success? Does the proposed project take 
advantage of unique features of the scientific environment or employ useful 
collaborative arrangements (including community involvement)? Is there 
evidence of institutional support? Are letters of support from organizations 
interested in being part of the partnership included?  Are resources 
available to perform the needs assessment? 

INQUIRIES

Written, e-mail, and telephone inquires concerning this RFA are encouraged 
particularly early in the application development process.  The opportunity 
to clarify any issues or questions from potential applicants is welcome.  All 
inquiries should be directed to one of the NIH staff listed below:

Scientific and Administrative Issues: 

Dr. Norman S. Braveman
Division of Extramural Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-24A, MSC 6402
Bethesda, MD 20892-6402
Telephone: (301) 594-2089
FAX:  (301) 480-8318
Email:  Norman.Braveman@nih.gov

Cathy L. Backinger, MPH, PhD
Division of Cancer Control and Population Sciences
National Cancer Institute
6130 Executive Blvd, EPN 4044
Rockville, MD  20852
Telephone:  (301) 496-8584
FAX:  (301) 496-8675
Email:  cb270r@nih.gov

Dr. Alice M. Horowitz
Office of Science Policy and Analysis
45 Center Drive, Room 3AN-44, MSC 6401
Bethesda, MD  20892-6401
Telephone: (301) 594-5391
FAX: (301) 435-8667
Email: Alice.Horowitz@nih.gov

Direct inquiries regarding fiscal matters to:

Mr. Martin R. Rubinstein
Division of Extramural Research
National Institute of Dental and Craniofacial Research
45 Center Drive, Room 4AN-44A, MSC 6402
Bethesda, MD 20892-6402
Telephone:  (301) 594-4800
Email:  Martin.Rubinstein@nih.gov

Schedule

Informational Conference: September 29, 2000
Letter of Intent Receipt Date: December 15, 2000
Application Receipt Date: February 16, 2001
Peer Review Date:  April, 2001
Council Review:  June, 2001                
Earliest Possible Funding: July 2001

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93. 121.  Awards are made under authorization of the Public Health Service 
Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 
USC 41 and 285) and administered under NIH grants policies and Federal 
Regulations 42 CFR 52 and 45 CFR Part 74 and 92.  This program is not subject 
to intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.

The PHS strongly encourages all grant and contract recipients to provide a 
smoke-free workplace and promote the non-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 
   
Canto, M. T., A. M. Horowitz, et al. (1998). “Maryland veterans' knowledge of 
risk factors for and signs of oral cancers and their use of dental services.” 
Gerodontology 15(2): 79-86.

Canto, M. T., Y. Kawagushi, et al. (1998). “Coverage and quality of oral 
cancer information in the popular press:1987-98.” J Public Health Dent 58(3): 
241-7.

Devesa, S. S., W. J. Blot, et al. (1990). “Cohort trends in mortality from 
oral, esophageal, and laryngeal cancers in the United States [see comments].” 
Epidemiology 1(2): 116-21.

DiGuiseppi, C., D. Atkins, et al. (1996). U.S. Preventive Services Task 
Force. Guide to clinical preventive services. Baltimore, Williams & Wilkins.

Gillison, M. L., W. M. Koch, et al. (1999). “Human papillomavirus in head and 
neck squamous cell carcinoma: are some head and neck cancers a sexually 
transmitted disease?” Curr Opin Oncol 11: 191-199.

Horowitz, A. M., H. S. Goodman, et al. (1996). “The need for health promotion 
in oral cancer prevention and early detection.” J Public Health Dent 56(6): 
319-30.

Horowitz, A. M., P. Nourjah, et al. (1995). “US adult knowledge of risk 
factors for and signs of oral cancers: 1990.” J Am Dent Assoc 126: 39-45.

Landis, S. H., T. Murray, et al. (1999). “Cancer statistics, 1999.” CA Cancer 
J Clin 49(1): 8-31, 1.

Potter, J. D., A. Chavez, et al. (1997). Food, nutrition and the prevention 
of cancer: a global perspective. Washington DC, World Cancer Research 
Fund/American Institute of Cancer Research.

Ries, L. A. G., C. L. Kosary, et al. (1999). SEER Cancer Statistics Review, 
1973-1996, National Cancer Institute.

Swango, P. A. (1996). “Cancer of the oral cavity and pharynx in the United 
States: an epidemilogic overview.” J Public Health Dent 56(6): 309-318.

Update January 1992: the American Cancer Society guidelines for cancer-
related check-up.(1992).  CA-Cancer J Clin 42: 44-45.

Wynder, E. L., M. H. Mushinski, et al. (1977). “Tobacco and alcohol 
consumption in relation to the development of multiple primary cancers.” 
Cancer 40(4 Suppl): 1872-8.

Yu MC, H. B. (1996). Nasopharyngeal Cancer. Cancer Epidemiology and 
Prevention. F. J. Schottenfeld D. New York, Oxford University Press: 603-618.

Zhang, Z., H. Morgenstern, et al. (1999). “Marijuana Use and Increased Risk 
of Squamous Cell Carcinoma of the Head and Neck.” Cancer Epidemiology, 
Biomarkers & Prevention 8: 1071-1078.


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