NIDCR EXPLORATORY AND DEVELOPMENTAL GRANTS IN CLINICAL RESEARCH
  
RELEASE DATE:  November 14, 2003
 
RFA Number:  RFA-DE-04-009

Department of Health and Human Services (DHHS)
 
PARTICIPATING ORGANIZATION:  
National Institutes of Health (NIH)
 (http://www.nih.gov/)
 
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Dental and Craniofacial Research (NIDCR)
 (http://www.nidcr.nih.gov/) 
 
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:
93.121 (Oral Diseases and Disorders)
 
LETTER OF INTENT RECEIPT DATE:  March 5, 2004
APPLICATION RECEIPT DATE:  April 14, 2004
 
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 Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA 

The National Institute of Dental and Craniofacial Research (NIDCR) 
recognizes that developmental, exploratory, or pilot studies in 
epidemiology, behavioral/social science research, or other areas of 
clinical research may be needed to collect preliminary data or 
establish an adequate foundation for R01 level clinical research 
addressing oral and craniofacial diseases and conditions. Thus, the 
NIDCR invites research grant applications to conduct developmental, 
exploratory, or pilot clinical research in areas where data are sparse 
or do not exist or where exploratory studies can establish an improved 
foundation for planning and developing sound R01 level clinical 
research grant applications. 

The goal of this announcement is to broadly encourage developmental, 
exploratory, or pilot clinical research that documents oral conditions 
and risk factors for oral and craniofacial diseases and disorders, 
investigates new methods of diagnosing oral disease, addresses 
behavioral research topics relevant to oral health, dental care, or 
oral health promotion, and /or identifies promising culturally 
appropriate approaches to prevent and reduce oral health disparities. 
This R-21 mechanism cannot be used to support pilot clinical trials.

RESEARCH OBJECTIVES
 
Background

The NIDCR research activities cover a broad range of disease and 
conditions affecting the oral, dental and craniofacial structures.  
Diseases and conditions of interest to NIDCR as well as prominent gaps 
in knowledge are briefly described below.  

Dental caries is one the most prevalent diseases. It can occur at any 
age after tooth eruption and primary teeth are especially vulnerable. 
In the U.S., 18% of preschoolers have experienced dental caries. 
Although the prevalence of dental caries has declined in the past three 
decades, this oral disease remains the most common chronic disease of 
childhood in the U.S.   By age 17, more than 80% of adolescents are 
affected by dental caries. However, dental caries is not evenly 
distributed throughout the population.  For example, approximately 25% 
of children 5-17 years of age experience 80% of dental caries. Studies 
have shown that the people at highest risk for dental caries are least 
able to seek help: the poor, the very young, the elderly, and those 
with compromising medical conditions or disabilities. 

Like dental caries, periodontal diseases are an infectious disease 
caused by bacteria in dental plaque. Periodontal diseases range from 
mild forms such as gingivitis to severe forms that result in loss of 
periodontal support and tooth loss.  Almost half of U.S. adults ages 35 
to 44 have gingivitis which is a reversible inflammation of the 
gingiva. Approximately one-fourth has the more severe condition of 
periodontitis that results in periodontal attachment loss of at least 4 
millimeters.  Severe periodontal disease (6 millimeters or more of 
attachment loss) affects 14 percent of adults ages 45 to 54, and 23 
percent of people 65 to 74-years of age. Tobacco use is a major risk 
factor for the development and progression of periodontal diseases.  
Furthermore, diabetes, particularly if poorly controlled, increases the 
risk for periodontal disease.  

Overall, data on the prevalence and risk factors for the infectious 
diseases of caries and periodontal disease come from national surveys, 
which report on white Non-Hispanics, Black non-Hispanics and Mexican 
Americans.  Limited data is available on other segments of the 
population such as other Hispanic subgroups, Asian and Pacific 
Islanders, Native Americans, other minority populations, and special 
needs populations. These data are critical to guide the development of 
effective and appropriate oral preventive and treatment modalities for 
people in these population groups. In addition, development and testing 
of new and innovative diagnostic methods for caries and periodontal 
diseases are needed to promote effective prevention and early 
intervention. 

Without adequate saliva individuals may experience rampant tooth decay, 
mucosal infections such as candidiasis, loss of taste, and considerable 
oral discomfort. Salivary gland dysfunction can occur as a result of 
Sjögren’s syndrome that affects between 1 and 4 million mostly middle-
aged women. Over 30,000 individuals who have cystic fibrosis also are 
at higher risk for salivary gland dysfunction.  In addition, each year, 
an estimated 40,000 people lose salivary gland function as a result of 
radiation treatment for head and neck cancer and many medications are 
associated with salivary gland dysfunction. Limited data exist on the 
epidemiology of salivary gland dysfunction and such data are needed to 
appropriately design research to prevent and treat this disorder.   
   
A number of chronic and disabling pain conditions have oral, dental, 
and craniofacial manifestations. Epidemiologic studies suggest that 
orofacial pain occurs in at least 10% of the adult population.  
Orofacial pain by itself or as a symptom of untreated oral problems is 
often a major source of poor quality of life.  Sources of orofacial 
pain include caries, some types of periodontal diseases, and 
neuropathic and musculoskeletal conditions.  Few well-designed studies 
on the prevalence, etiology and pathogenesis of orofacial pain of non-
dental origin are available. In addition, limited data are available on 
the underlying causes of muscular and joint facial pain that may 
involve physiological, behavioral or environmental factors.     

Numerous hereditary diseases, syndromes, developmental and acquired 
disorders have oral and craniofacial manifestations with serious 
functional, esthetic and social consequences. Craniofacial anomalies 
are among the most common of all birth defects.  Birth defects and 
developmental disorders can be isolated or may be part of complex 
hereditary diseases or syndromes.  Cleft lip and cleft palate occurs in 
about 1 to 2 out of 1,000 births in the U.S. Diseases of the bones and 
connective tissue such as Paget’s disease and osteogenesis imperfecta, 
osteoporosis, and scleroderma can have devastating oral and 
craniofacial effects. Similarly, ulcers and erosive lesions associated 
with oral and pharyngeal cancer treatment, immune dysfunction, 
infectious diseases such as herpes simplex, HIV/AIDS, fungal infection, 
aphthae as well as dermatologic and hematologic diseases may also have 
serious oral and general health implications. Additional research is 
needed to identify risk factors associated with these diseases so that 
effective means of preventing and treating these conditions may be 
developed and tested in clinical trials. 

Oral facial injuries can lead to disfigurement and oral dysfunction.  
While it is recognized that the leading causes of oral and craniofacial 
injuries are sport, violence, falls and motor vehicle collisions, there 
has been only limited research on the epidemiology, prevention, and 
behavioral consequences of orofacial injuries.

The age-adjusted incidence rate of oral cancer for total oral cavity and 
pharynx was 10.3 per 100,000 people in 1999 and this 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. 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, treatment for these 
malignancies can be extremely disfiguring and often results in severe 
loss of function including speech impairment and the inability to 
swallow. Identification of effective means of screening and early cancer 
diagnosis is an important priority of the NIDCR.  

For the purpose of this RFA, people with special needs include those 
with developmental or acquired physical or mental disabilities, people 
with mental retardation (MR), people living with HIV/AIDS, and frail or 
functionally dependent elders. There are limited data documenting that 
individuals with these special needs are at increased risk for dental 
and oral disease. Such data are critical to guide the development of 
effective and appropriate oral preventive and treatment modalities for 
people with special needs.    

Goal and Scope

This RFA provides funds for exploratory, developmental, or pilot 
clinical research that can help expand the scope of the NIDCR’s 
clinical research portfolio and its potential impact on oral health in 
the U.S. Some relevant aims for exploratory studies include: 1) 
documenting the prevalence, incidence, and risk factors for oral and 
craniofacial diseases and disorders, 2) investigating new methods for 
diagnosing oral disease, 3) examining determinants of behaviors that 
influence oral health or treatment outcomes and identifying approaches 
to increase behaviors supporting oral health, 4) identifying culturally 
appropriate preventive and treatment approaches for reducing oral 
health disparities, and 5) stimulating research directed to improving 
the oral health of special needs populations, including those with 
developmental or acquired physical or mental disabilities, people with 
mental retardation, people living with HIV/AIDS, and frail or 
functionally dependent elders. 

Applicants are encouraged to review the NIDCR Strategic Plan 
(http://www.nidcr.nih.gov/about/strat-plan/) issued in 2003 and NIDCR’s 
Plan to Eliminate Oral Health Disparities 
(http://www.nidcr.nih.gov/research/healthdisp/hdplan.pdf).

Examples of exploratory research that would be responsive to this RFA 
include, but are not limited to the following:

o Development, testing, and validation of methods for determining 
prevalence, incidence, risk factors and determinants of disease for a 
wide variety of oral diseases and orofacial pain in the general 
population and in minority and special needs populations

o Development and /or testing of new diagnostic methods for diagnosing 
oral or craniofacial diseases or conditions

o Development, testing, and validation of methods to measure the impact 
of oral health-related quality of life on the general health in special 
needs populations

o Development and preliminary testing of innovative ways to improve 
oral health of people with special needs

o Development of innovative health promotion approaches (social, 
educational, legal, fiscal) to address environmental, behavioral and 
biological determinants of oral health and oral health-related quality 
of life

o Development of ways to improve dissemination and implementation of 
research findings to people with special needs, their caregivers, and 
health care professionals

o Testing novel use of technology to improve dissemination of oral 
health information, compliance with recommendations for oral health 
care, oral health literacy, and oral health.

o Exploratory clinical studies on cognitive neuroscience and persistent 
orofacial pain conditions.

o Studies on the genetic and environmental determinants of oral health.

o Studies using available databases to explore factors related to oral 
diseases and conditions, especially for high risk or poorly studied 
population subgroups.

o Studies assessing gaps in oral health knowledge, attitudes and 
behaviors of the public and providers and developing innovative 
strategies to address such gaps.

o Investigations aimed at clarifying the determinants of behaviors 
influencing oral health and evaluating promising strategies to improve 
oral health. 

o Studies assessing oral health literacy and language skills as these 
relate to oral health or treatment outcomes.

o Studies assessing the impact of parent-child education or other 
interventions in dental settings relative to injury prevention, 
prevention of tobacco use, or dietary changes promoting oral health. 

In summary, a central focus of this RFA is to encourage developmental, 
exploratory, or pilot epidemiological and behavioral science research 
that addresses goals and objectives identified in the NIDCR’s Strategic 
Plan and that have the potential for strengthening NIDCR’s portfolio of 
clinical research. Some of these exploratory projects may strengthen 
the capability for developing scientifically meritorious clinical 
trials by identifying pertinent risk factors or promising interventions 
that warrant larger scale research efforts or multi-site clinical 
trials (see also  
http://www.nidcr.nih.gov/clinicalTrials/Clinical_Trials_Program.asp).

MECHANISM OF SUPPORT
 
This RFA will use the NIH Exploratory/Developmental (R21) award 
mechanism(s).  As an applicant you will be solely responsible for 
planning, directing, and executing the proposed project.  This RFA is a 
one-time solicitation.  Future unsolicited, competing-continuation 
applications based on this project will compete with all investigator-
initiated applications and will be reviewed according to the customary 
peer review procedures. The anticipated award date is September 30, 
2004.  Applications that are not funded in the competition described in 
this RFA may be resubmitted 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 
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 budget format.  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 
 
The NIDCR intends to commit approximately $1.5 million in FY 2004 to 
fund 8 to 10 new grants in response to this RFA. Applicants may request 
a project period of up to two years with a combined budget for direct 
costs of up $275,000 for the two-year period.  For example, the 
applicant may request $100,000 in the first year and $175,000 in the 
second year.  The request should be tailored to the needs of the 
project. Normally, no more than $200,000 may be requested in any single 
year. Although the financial plans of the NIDCR 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.  
 
ELIGIBLE INSTITUTIONS
 
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
o Foreign institutions are not eligible to apply
o Faith-based or community-based organizations
 
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.   

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:

o Direct your scientific questions about epidemiology research issues 
to:

Maria Teresa Canto, DDS, MPH
Director, Population Sciences Research Program
Clinical, Epidemiology & Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of 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

o Direct your scientific questions about behavioral research issues to:

Patricia S. Bryant, PhD
Director, Behavioral and Social Science Research Program
Clinical, Epidemiology & Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental & Craniofacial Research 
National Institutes of Health 
45 Center Drive, Room 4AS43A
Bethesda, MD  20892-6401
Telephone:(301) 594-2095
Fax: (301) 480-8319
E-mail: patricia.bryant@nih.gov

o Direct your scientific questions about special needs populations and 
oral health disparities research issues to:

Ruth Nowjack-Raymer, MPH, PhD
Director, Health Disparities Research Program
Clinical, Epidemiology & Behavioral Research Branch
Division of Population and Health Promotion Sciences
National Institute of Dental & Craniofacial Research 
National Institutes of Health 
45 Center Drive, Room 4AS43J
Bethesda, MD  20892-6401
Telephone:(301) 594-5394
Fax: (301) 480-8319
E-mail: ruth.nowjack-raymer@nih.gov

o Direct your questions about peer review issues to:

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

o Direct your 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, PhD
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, Maryland  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). Applications must 
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form. The PHS 398 document is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.
 
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/labels.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and three signed, 
photocopies, in one package to:
 
Center For Scientific Review
National Institutes Of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application and 
all copies of the appendix material must be sent to:

H. George Hausch, PhD
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-44F
Bethesda, Maryland  20892-6402
Telephone: (301)594-2904
Fax: (301)-480-8303
Email: George.Hausch@nih.gov
 
APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review. 

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignment within 8 weeks.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  However, when a previously 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.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NIDCR. Incomplete applications will not be 
reviewed.
  
If the application is not responsive to the RFA, NIH staff may contact 
the applicant to determine whether to return the application to the 
applicant or submit it for review in competition with unsolicited 
applications at the next appropriate NIH review cycle.

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 Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications 
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the National Advisory Dental and 
Craniofacial Council (NADCRC).
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  
Reviewers will be asked to evaluate the R21 application in light of the 
goals of the subsequent full-scale study (R01 type) to evaluate whether 
the proposed research is likely to have a substantial impact on the 
pursuit of these goals. The scientific review group will address and 
consider each of the following criteria in assigning the application’s 
overall score, weighting them as appropriate for each application. 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The application does not need to be strong in all categories to be 
judged likely to have major scientific impact and thus deserve a high 
priority score.  For example, an investigator may propose to carry out 
important work that by its nature is not innovative but is essential to 
move a field forward. 

SIGNIFICANCE: Does this study address an important problem for which 
developmental, exploratory, or pilot research is needed prior to the 
initiation of a full-scale (R01 type) study? Will the proposed R-21 
research generate concepts, methods, or findings that will support a 
subsequent full-scale (R01 type) study? Are the planned questions/aims 
that are posed for the full-scale study important and, if achieved, 
lead to significant advancement of scientific knowledge? 

APPROACH: Does the applicant identify gaps that are critical to 
carrying out the full-scale clinical research study? Are the conceptual 
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 
tactics? To what degree will support of the proposed developmental, 
exploratory or pilot research assist in the conduct of the full- scale 
study? Does the applicant demonstrate that once the 
developmental/exploratory research is completed a full-scale study 
could be carried out?

INNOVATION: Is it likely that the developmental, exploratory, or pilot 
project will lead to full-scale research that employs novel concepts, 
approaches or methods? Are the aims original and innovative? Does the 
project challenge existing paradigms or develop new methodologies or 
technologies?

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

ENVIRONMENT: Does the scientific environment in which the 
developmental, exploratory, or pilot research and full-scale study 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 and / or community support?

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

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

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

ADDITIONAL REVIEW CONSIDERATIONS

BUDGET:  The reasonableness of the proposed budget and the requested 
period of support in relation to the proposed research will be 
evaluated.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date: March 5, 2004 
Application Receipt Date: April 14, 2004
Peer Review Date: June/July 2004
Council Review: August 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. 
Potential applicants may obtain a copy of "Healthy People 2010" at 
http://www.healthypeople.gov/.

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject 
to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under the 
authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92. All awards are subject to the terms and 
conditions, cost principles, and other considerations described in the 
NIH Grants Policy Statement.  The NIH Grants Policy Statement can be 
found at http://grants.nih.gov/grants/policy/policy.htm.

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

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