STATE MODELS FOR ORAL CANCER PREVENTION AND EARLY DETECTION - PHASE II

RELEASE DATE:  June 23, 2003
 
RFA:  DE-04-005 

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER (S): 93.121 (Oral 
Diseases and Disorders), 93.399 (Cancer Control)

LETTER OF INTENT RECEIPT DATE:  November 14, 2003 

APPLICATION RECEIPT DATE:  December 17, 2003

THIS RFA CONTAINS THE FOLLOWING INFORMATION

o    Purpose of this RFA
o    Research Objectives
o    Mechanism(s) of Support 
o    Funds Available
o    Eligible Institutions
o    Individuals Eligible to Become Principal Investigators
o    Purpose of This RFA
o    Special Requirements
o    Where to Send Inquiries
o    Letter of Intent
o    Submitting an Application
o    Peer Review Process
o    Review Criteria
o    Receipt and Review Schedule
o    Award Criteria
o    Required Federal Citations

PURPOSE OF THIS RFA

The National Institute of Dental and Craniofacial Research (NIDCR, NIH, 
DHHS) and the National Cancer Institute (NCI, NIH, DHHS) invite 
applications for research grants to design, implement and evaluate 
interventions for oral cancer prevention and early detection.  The 
interventions must be based on a state needs assessment for these 
cancers among the public and providers. Goals of these interventions 
are to raise awareness about oral cancer risk factors and prevention 
and to promote the early detection of oral malignancies.  The needs 
assessment could have been funded by the NIDCR or other sources.

RESEARCH OBJECTIVES

In  2002 it was estimated that oral and pharyngeal cancers would 
account for 28,900 cases and 7,400 deaths in the United States (Jemal 
et al., 2002).  More than 90% of oral cancers occur in individuals 45 
years of age and over (Ries et al., 2002).  Recently, reports indicate 
an increase in tongue cancer among younger individuals (Myers et al., 
2000; Pitman et al., 2000).  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 et al., 1996 ; Ries et al., 1999).  The age-
adjusted incidence rate for total oral cavity and pharynx cancers was 
10.3 per 100,000 population in 1999 (Ries, et al., 2002).  This 
incidence rate represents approximately 3% of all cancers in the United 
States.  The overall five-year survival rate is 53%, and it has not 
changed in the past thirty years (Silverman, 2001; Canto and Devesa, 
2002).  This five-year survival rate represents one of the lowest five-
year survival rates of any of the major cancer sites.  These low 
survival rates may be attributed to the fact that these cancers tend to 
be diagnosed at advanced stages.  Moreover, the treatment for these 
malignancies are extremely disfiguring and often result in severe loss 
of function including inability to swallow and impairment of speech. 

Major risk factors for oral cancers in the United States are use of 
tobacco and alcohol.  Use of these two products account for 75% of all 
oral cancers (Wynder et al., 1977).  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 (Devesa et al., 1990).  Other 
risk factors include exposure to viruses such as human papillomavirus 
(Gillison et al., 1999) and Epstein-Barr virus (Yu MC, 1996).  In 
addition, a case-control study suggests that marijuana use may increase 
the risk for head and neck cancer (Zhang et al., 1999). Conversely, 
lower risk of oral cancers is associated with an increased consumption 
of fruits and vegetables (Potter 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 (oral sex) and 
sunlight.

Secondary prevention consists of a visual and tactile examination of 
the oral cavity, head and neck, which is essential for early detection.  
Because of the significant morbidity and mortality associated with the 
diagnosis of oral cancer at advanced 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 (Smith et al., 2002; Horowitz, et al., 1996).  The U.S Prevention 
Services Task Force recommends that clinicians include a careful 
examination/screening for oral cancer in asymptomatic individuals who 
use tobacco or alcohol (DiGuiseppi 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/screening, other health care providers  (i.e., nurse 
practitioners, physician assistants, physicians) could 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 (Horowitz et al., 2000).   In this survey, 
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, especially palpating lymph nodes 
(Forrest et al., 2001). 

These national surveys also addressed the age group of patients 
receiving an oral cancer examination/screening 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/screening for edentulous patients 18 years of age or older.  
Eighty one percent provided an oral cancer examination/screening to all 
their dentate patients above 40 years of age during the initial visit 
(Yellowitz et al., 2000).  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 while 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 
(Horowitz, et al., 2000).  

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 (Horowitz et al., 1995).  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 only 7% in the past year.  A survey 
conducted in the state of Maryland found a low level of knowledge about 
risk factors for and signs and symptoms of oral cancers.  In this 
survey, only 28% of respondents reported ever having an oral cancer 
examination; and, of these, only 20% had an oral cancer examination in 
the past year (Horowitz et al., 1998).  Lack of adequate knowledge by 
the general public was partially explained by minimal coverage of oral 
cancers in popular magazines and newspapers (Canto et al., 1998b) and 
limited availability of oral cancer educational materials designed for 
the public (Chung et al., 2000).

To achieve the Healthy People 2010 objectives, changes must be made at 
the state level since oral cancer awareness and practices 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 provide oral 
cancer examinations/screening.  Thus, 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.  Further, the interventions must be tailored to the 
particular needs of that state. 

Goals and Scope

The purpose of this Request for Applications (RFA) for State Models for 
Oral Cancer Prevention and Early Detection-Phase II is to provide 
funding for the design, implementation and evaluation of interventions 
based on a needs assessment regarding oral cancer.  This needs 
assessment could have included some or all of the following:  (a) an 
epidemiological assessment of the level of oral cancer within the 
state; (b) an assessment of the level of knowledge of oral cancer risk 
factors among health professions and the public; (c) documentation and 
assessment of practices in diagnosing oral cancers in health 
professions; and (d) an assessment of whether adults are receiving an 
oral cancer examination/screening annually from a healthcare provider. 
Based on the findings from a needs assessment, applicants to this RFA 
will design, implement and evaluate interventions to raise awareness 
about oral cancer risk factors and prevention and promote the early 
detection of oral cancers.  

An emphasis is placed on a state approach 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, tobacco control, 
policies regarding use of tobacco settlement dollars and awareness of 
oral cancer prevention and early detection by the public and health 
professionals. The five-year grant is expected to use the 
organizational infrastructure and the plan of action from the needs 
assessment to determine the type of interventions require in that state 
to promote the prevention and early detection of oral and pharyngeal 
cancers. 

Some of the interventions may be designed for health care providers.  
Based on the research literature on dissemination of information to 
health care providers, printed materials (including journal articles) 
don't have a strong effect on changing the behavior of health care 
providers.  Behavioral changes are more enduring when addressing 
regulatory, normative, economic, and peer influences.  Examples of 
regulatory influence include third party reimbursement policies, 
tobacco control policies, the threat of malpractice and sanctions by 
peer review or other authoritative bodies.  Normative influences refer 
to those influences during professional training.  Interventions 
conducted during professional training or bridging the transition 
between training and early years of practice provide some unique 
opportunities to test impacts of normative influences on subsequent 
practice behaviors.   A combination of strategies and interventions may 
be more powerful in changing the clinical practice behaviors of well-
established, experienced health care providers.  

Also, interventions designed for the public are essential and they 
should address the determinants of behaviors such as social norms, 
attitudes, feelings of self-efficacy, literacy and prior habits.  
Overall for successful behavioral changes a combination of 
interventions for both providers and the public is crucial.

Examples of interventions appropriate to this initiative include but 
are not limited to the following: 

o Providing innovative continuing education courses for providers
o Media involvement – presentations in radio or TV programs
o Sponsoring an oral cancer awareness week in the state, county or city
o Development of educational materials for specific target groups
o Partnering with agencies and institutions providing services to 
individuals at high risk   
o Inclusion of oral cancer in tobacco cessation programs
o Providing educational activities at barber shops or other locations 
as identified by the needs assessment
o Developing campaigns of oral cancer prevention with sport 
organizations 
o Developing innovative approaches to integrate the delivery of oral 
cancer examinations with other preventive services

Illustrative examples of the finals outcomes that could be measured by 
the Phase II interventions may be an increase in the:  

1)  Number and types of providers doing oral cancer 
examination/screening, 
2)  Number of providers that feel confident about providing an oral 
cancer examination/screening, 
3)  Number of providers using adjunct procedures for early detection 
of oral and pharyngeal cancers 
4)  Increased knowledge of oral cancer risk factors among providers 
and the public
5)  Increased number of providers having an oral cancer continuing 
education course in the past five years
6)  Increased number of providers assessing tobacco use
7)  Increased number of providers assessing alcohol use
8)  Policy and/or legislation to encourage providers to do an oral 
cancer examination/screening
9)  Increase the number of adults who had an oral cancer 
examination/screening the past year

Other possible outcomes could be: 1) the inclusion of oral cancer in 
the cancer control program of the state, 2) the development of oral 
cancer educational materials targeting populations at risk in the 
state, 3) an increase in time devoted to oral cancer training in 
medical, dental, dental hygiene, physician assistants, or nursing 
programs at state and private universities or colleges, and 4) the 
development of educational interventions among targeted populations.

MECHANISM OF SUPPORT

This RFA will use NIH Research Project Grant (R01) award mechanism.  As 
applicant you will be solely responsible for planning, directing, and 
executing the proposed project.  This RFA is a one-time solicitation.  
Future unsolicited, competing-continuation applications based on this 
project will compete with all investigator-initiated applications and 
will be reviewed according to the customary peer review procedures.  
The anticipated award date is September 30, 2004.   Applications that 
are not funded in the competition described in this RFA may be 
submitted as NEW investigator-initiated applications using the standard 
receipt dates for NEW applications described in the instructions to the 
PHS 398 application.  

This RFA uses just-in-time concepts.  It also uses the modular as well 
as the non-modular budgeting formats. (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less, use the modular format.  Otherwise 
follow the instructions for non-modular research grant applications.   
This program does not require cost sharing as defined in the current 
NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.  

FUNDS AVAILABLE

NIDCR and NCI intend to commit $1,500,000 total costs in FY2004 or FY 
2005 to fund 3 new grants in response to this RFA.  An applicant may 
request a project period of up to 5 years and a budget for direct costs 
of up to $333,000 per year.  Because the nature and scope of the 
proposed research will vary from application to application, it is 
anticipated that the size and duration of each award will also vary.  
Although the financial plans of the IC(s) provide support for this 
program, awards pursuant to this RFA are contingent upon availability 
of funds and the receipt of a sufficient number of meritorious 
applications.    

ELIGIBLE INSTITUTIONS

You may submit (an) R01 if your institution has any of the following 
characteristics: 

o For-profit or non-profit organizations 
o Public or private institutions, such as universities, colleges, 
hospitals, and laboratories 
o Units of state and local governments
o Eligible agencies of the Federal government  

Foreign institutions are not eligible under this RFA.

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with their 
institution to develop an application for support.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.   

SPECIAL REQUIREMENTS 

An eligibility requirement is to have completed a needs assessment for 
oral cancer in a state.   This needs assessment could have included 
some or all of the following:  (a) an epidemiological assessment of the 
level of oral cancer within the state; (b) an assessment of the level 
of knowledge of oral cancer risk factors among health professions and 
the public; (c) document and assess practices in diagnosing oral 
cancers in health professions; and (d) an assessment of whether or not 
the public is receiving an oral cancer examination/screening annually 
from a healthcare provider. The needs assessment may have been funded 
by the NIDCR or other sources. 

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

WHERE TO SEND INQUIRIES

We encourage inquiries concerning this RFA and welcome the opportunity 
to answer questions from potential applicants.  Inquiries may fall into 
three areas:  scientific/research, peer review, and financial or grants 
management issues:

Direct inquiries regarding programmatic issues:

Maria Teresa Canto, DDS, MPH
Director, Population Sciences Research Program
Clinical, Epidemiology & Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute Dental & Craniofacial Research 
National Institutes of Health 
45 Center Drive, Room 4AS43B
Bethesda, MD  20892-6401
Telephone:(301) 594-5497
Fax: (301) 480-8319
E-mail: maria.canto@nih.gov

Direct inquiries regarding peer review matters to:

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

Direct questions about financial or grants management matters to:

Mary Daley
Grants Management Branch
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN44B
Bethesda, MD  20892-6402
Telephone: 301-594-4808
FAX: 301-480-3562
Email: daleym@mail.nih.gov

LETTER OF INTENT

Prospective applicants are asked to submit a letter of intent that 
includes the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel 
o Participating institutions
o Number and title of this RFA 

Although a letter of intent is not required, is not binding, and does 
not enter into the review of a subsequent application, the information 
that it contains allows IC staff to estimate the potential review 
workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning 
of this document.  The letter of intent should be sent to:

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

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). The PHS 398 is also 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format. For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov. R01 applications 
not conforming to the requested format will be returned to the 
applicant without review.     

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and three signed, 
photocopies, in one package to:

Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)

At the time of submission, two additional copies of the application 
must be sent to:

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

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

APPLICATION PROCESSING: Applications must be received 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.  While the investigator may still benefit from the previous 
review, the RFA application is not to state explicitly how.

PEER REVIEW PROCESS  

Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the participating ICs.  Incomplete and/or non-
responsive applications will be returned to the applicant without 
further consideration.

Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by the NIDCR in accordance with the review 
criteria stated below.  As part of the initial merit review, all 
applications will:

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications 
under review, will be discussed and assigned a priority score
o Receive a second level review by an appropriate national advisory 
council or 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 your application in order to judge the likelihood 
that the proposed research will have a substantial impact on the 
pursuit of these goals: 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

Applications received in response to this RFA will be reviewed by 
Special Emphasis Panel (SEP) organized by NIDCR or CSR. The scientific 
review group will address and consider each of these criteria in 
assigning your application's overall score, weighting them as 
appropriate for each application.  Your application does not need to be 
strong in all categories to be judged likely to have major scientific 
impact and thus deserve a high priority score.  For example, you may 
propose to carry out important work that by its nature is not 
innovative but is essential to move a field forward.

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

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

(3)  INNOVATION:  Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does the project employ 
innovative approaches for attaining the aims and objectives?

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

(5)  ENVIRONMENT:  Does the scientific environment in which the work 
will be done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support?

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of 
human subjects and protections from research risk relating to their 
participation in the proposed research will be assessed. (See criteria 
included in the section on Federal Citations, below).
 
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy 
of plans to include subjects from both genders, all racial and ethnic 
groups (and subgroups), and children as appropriate for the scientific 
goals of the research.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the 
sections on Federal Citations, below).

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001) 
will be assessed.  

ADDITIONAL CONSIDERATIONS 

DATA SHARING:  The adequacy of the proposed plan to share data.
 
BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  November 14, 2003             
Application Receipt Date:  December 17, 2003                  
Peer Review Date:  January/February 2004                             
Council Review:  May/June 2004                                 
Earliest Anticipated Start Date:  September 30, 2004          

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

o   Scientific merit (as determined by peer review)
o   Availability of funds
o   Programmatic priorities.

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated 
with reference to the risks to the subjects, the adequacy of protection 
against these risks, the potential benefits of the research to the 
subjects and others, and the importance of the knowledge gained or to 
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm  

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the 
policy of the NIH that women and members of minority groups and their 
sub-populations must be included in all NIH-supported clinical research 
projects unless a clear and compelling justification is provided 
indicating that inclusion is inappropriate with respect to the health of 
the subjects or the purpose of the research. This policy results from 
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).

All investigators proposing clinical research should read the "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in 
Clinical Research - Amended, October, 2001," published in the NIH Guide 
for Grants and Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH 
definition of clinical research; updated racial and ethnic categories 
in compliance with the new OMB standards; clarification of language 
governing NIH-defined Phase III clinical trials consistent with the new 
PHS Form 398; and updated roles and responsibilities of NIH staff and 
the extramural community.  The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or 
proposals and/or protocols must provide a description of plans to 
conduct analyses, as appropriate, to address differences by sex/gender 
and/or racial/ethnic groups, including subgroups if applicable; and b) 
investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN 
SUBJECTS:  The NIH maintains a policy that children (i.e., individuals 
under the age of 21) must be included in all human subjects research, 
conducted or supported by the NIH, unless there are scientific and 
ethical reasons not to include them. This policy applies to all initial 
(Type 1) applications submitted for receipt dates after October 1, 
1998.

All investigators proposing research involving human subjects should 
read the "NIH Policy and Guidelines" on the inclusion of children as 
participants in research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm . 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject 
participants for all investigators submitting NIH proposals for 
research involving human subjects.  You will find this policy 
announcement in the NIH Guide for Grants and Contracts Announcement, 
dated June 5, 2000, at           
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html .

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom 
of Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm .

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time.  If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

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

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, 
including a complete Regulation Text and a set of decision tools on "Am 
I a covered entity?"  Information on the impact of the HIPAA Privacy 
Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts 
can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and 
proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, 
Internet addresses (URLs) should not be used to provide information 
necessary to the review because reviewers are under no obligation to 
view the Internet sites.  Furthermore, we caution reviewers that their 
anonymity may be compromised when they directly access an Internet 
site.

HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of 
"Healthy People 2010," a PHS-led national activity for setting priority 
areas. This RFA is related to one or more of the priority areas. 
Specifically it addresses Healthy People 2010 objectives related to 
oral health, drug dependence and addiction, and tobacco.  Potential 
applicants may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople .

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/.  This program is 
described in the Catalog of Federal Domestic Assistance Nos. 93.121 
(NIDCR) and 93.399 (NCI) and is not subject to the intergovernmental 
review requirements of Executive Order 12372 or Health Systems Agency 
review.  Awards are made under authorization of Sections 301 and 405 of 
the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal 
Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. 

The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products.  In 
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits 
smoking in certain facilities (or in some cases, any portion of a 
facility) in which regular or routine education, library, day care, 
health care, or early childhood development services are provided to 
children.  This is consistent with the PHS mission to protect and 
advance the physical and mental health of the American people.
 
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