and Human Services (HHS)
EXPIRED
DEVELOPMENT OF TECHNOLOGIES FOR SALIVA/ORAL FLUID BASED DIAGNOSTICS
Release Date: January 2, 2002
RFA: RFA-DE-02-002
National Institute of Dental and Craniofacial Research
(http://www.nidr.nih.gov/)
Letter of Intent Receipt Dates: March 11, 2002
Application Receipt Dates: April 11, 2002
PURPOSE
The National Institute of Dental and Craniofacial Research (NIDCR)
invites Cooperative Agreement Applications (U01) for outstanding
multidisciplinary research aimed at the development of new
technologies, for which proof-of-principle exists, or for the
advancement of existing technologies for simultaneous multi-analyte
detection in saliva and other oral fluids. The focus of such diagnostic
technologies will primarily be in the areas in which saliva or other
oral fluid based diagnostics can have a major impact: i) oral
diagnostics (e.g., periodontal diseases, dental caries and oral
cancers), ii) systemic disease diagnosis (e.g., autoimmune diseases,
cardiovascular disease and cancers), iii) drug monitoring, (e.g., drug
compliance, pharmacokinetics and pharmacogenomics) and iv)
identification of potentially lethal agents (e.g., anthrax bacillus or
chemical agents) dispersed by bioterrorists.
Because of the nature of the research required to stimulate the
development and transition of current diagnostic technologies (e.g.,
miniaturized analytical systems, microfluidics, microsensors) for the
detection of saliva/oral fluid derived markers, it is expected that
potential applicants will include investigators with expertise in
technology development, chemistry, engineering, physics, biology,
bioinformatics and clinical sciences.
The development of saliva/oral fluid based diagnostic technology
projects is likely to be design-directed rather than hypothesis-driven
research. Therefore, rather than presenting a hypothesis and an
experimental plan to test it, applicants should address: i) the design
goals (a detailed statement of what the development of the
device/method will accomplish), ii) the design tasks (description of
the status of the device/method prior to funding and additional design
aspects that will be completed during the funding period), iii) the
program plan (includes the overall plan, with a timetable, for
accomplishing and coordinating design, fabrication, and testing,
achieving robust operation and high quality data), and iv) the
anticipated barriers and approaches for overcoming them.
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), "Development of Technologies for Saliva/Oral Fluid
Based Diagnostics" is related to one or more of the NIDCR priority
areas. Potential applicants may obtain a copy of "Healthy People 2010"
at: http://www.health.gov/healthypeople/.
ELIGIBILITY REQUIREMENTS
Applications may be submitted from domestic institutions, for-profit
and non-profit organizations, public and private, such as universities,
colleges, hospitals, laboratories, units of State and local
governments, and eligible agencies of the Federal government, and
faith-based organizations. Racial/ethnic minority individuals, women,
and persons with disabilities are encouraged to apply as Principal
Investigators. Applications from foreign institutions will not be
accepted. However, subcontracts to foreign institutions will be
considered.
All current policies and requirements that govern the research grant
programs of the National Institutes of Health (NIH) will apply to
grants awarded under this RFA.
MECHANISM OF SUPPORT
This RFA will use the NIH cooperative research (U01) award mechanism of
support, an "assistance" mechanism (rather than an "acquisition"
mechanism) in which substantial NIH scientific and/or programmatic
involvement with the awardee is anticipated during performance of the
activity. Under the cooperative agreement, the NIH purpose is to
support and stimulate the recipients" activity by involvement in the
activity and otherwise working jointly with the award recipients in a
partner role, but it is not to assume direction, prime responsibility,
or a dominant role in the activity. Details of the responsibilities,
relationships and governance of the study to be funded under
cooperative agreements are discussed below under "TERMS AND CONDITIONS
OF AWARD."
The total requested project period for an application submitted in
response to this RFA may not exceed 4 years. This is a one-time
solicitation. At this time, the NIDCR has not determined whether or how
this solicitation will be continued beyond the present RFA.
The maximum dollar request is limited to $1.00 million in total costs
for the initial budget period and $4.2 million in total costs for the
entire project period. The anticipated award date is September 30,
2002.
FUNDS AVAILABLE
For Fiscal Year 2002, $3.00 million in total costs will be committed to
fund applications submitted in response to this RFA. It is anticipated
that 2-3 awards will be made. Proposed funding levels are subject to
change due to budgetary, administrative and/or scientific
considerations, and are dependent upon the receipt of a sufficient
number of applications of high scientific merit. Although this program
is provided for in the financial plans of the NIDCR, the award of
grants pursuant to this RFA is also contingent upon the availability of
funds for this purpose.
RESEARCH OBJECTIVES
Background
The composition of saliva and of other oral fluids reflects tissue
fluid levels of therapeutic, hormonal, immunological or toxicological
molecules, as well as the presence of markers for infectious and
neoplastic diseases. These fluids provide sources for assessment and
monitoring of systemic health and disease states and exposure to
environmental, occupational, or abusive substances as well as to agents
dispersed by bioterrorists.
Proof-of-principle has been established regarding the use of saliva and
other oral fluids to monitor a number of systemic diseases and
conditions as well as substance abuse. The analysis of these fluids,
therefore, has great diagnostic potential in a variety of clinical
situations. Oral fluid based diagnostics may, in many instances, prove
more accurate and less expensive, than current methodologies. Moreover,
they are non-invasive.
Although oral fluids, particularly saliva, have been used for the
diagnosis of some diseases, progress has not met expectations. In 1993
a conference supported by the NIDCR was held to explore the
possibilities for maximizing the utility of saliva as a diagnostic
medium. The conference report stated that the development of new
technologies with increased sensitivity and accuracy would undoubtedly
increase the use of saliva in diagnostics. To date, remarkable
technological advances are promising to revolutionize the field of
diagnostics as we now know it. Techniques that are emerging from a
combination of miniaturization technologies and discoveries in many
different fields of biology, chemistry, physics and engineering are
expected to lead to high throughput, automated, portable, low cost,
more efficient, and rapid biochemical analyses. Miniaturization of
diagnostic technologies will be able, with minute amounts of body
fluids, to yield critical patient information reflecting health and
disease status. Scientists predict that pocket-sized analyzers ("lab-
on-a-chip") that can perform multiple operations in parallel in non-
laboratory settings such as battlefields, airports, factories,
hospitals, clinics or homes will be developed. Current technologies
provide a basis for these kinds of tests/devices that will allow the
simultaneous assessment of multiple analytes in health and disease and
will provide clinicians with new prevention and therapeutic strategies.
The NIDCR, realizing the potential of new technologies and advanced
instrumentation in the development of saliva and other oral fluid-based
diagnostics sponsored a workshop on "Development of New Technologies
for Saliva and Other Oral Fluid Based Diagnostics" on September 12-14,
1999. The purpose of this workshop was to capitalize on recent and
future developments in this field. More than 100 individuals from
university and industry with expertise in salivary and oral biology,
instrumentation, engineering and clinical sciences participated. Their
charge was to develop a set of recommendations to help the NIDCR create
a research program in the area of oral fluid based diagnostics.
Briefly, these experts recommended a need to:
1. Establish new interdisciplinary/collaborative programs combining
dental, medical, biological, chemical and engineering sciences to
create innovative technologies such as microfluidics, recognition
chemistry, and computer engineering for oral fluid based
diagnostics,
2. Foster academic-industry partnerships and broaden interactions with
government laboratories,
3. Increase emphasis on training of a new cadre of individuals with
expertise that can facilitate collaborations among disciplines
(single or multi-institution based) to train graduate students,
postdoctoral fellows, and clinical fellows.
The summary of the recommendations of the workshop participants has
been published on the NIDCR"s home page
http://www.nidr.nih.gov/about/strat-plan/Biomat_Biomet_Tiss_Eng.PDF.
SCOPE
To be eligible for support under this program, a technology must have
been developed to the stage that proof-of-principle has been
demonstrated. To warrant the investment that will be needed to
accomplish the requested goals, the technologies involved must be able
to contribute to automated, low cost, more efficient, and rapid
analyses for simultaneous multi-analyte detection. This program will
support the range of activities required to drive the development and
transition of current diagnostic technologies (e.g., miniaturized
analytical systems, microfluidics, microsensors) for the detection of
saliva/oral fluid derived markers. Included are the development of
technologies and fabrication of devices for simultaneous multi-analyte
detection in saliva or other oral fluids that will allow assessment of
multiple conditions regarding diagnosis, prognosis, pharmacokinetics,
prediction of adverse pharmacological interactions and identification
of potentially lethal agents dispersed by bioterrorists. This may
involve:
1. Design and fabrication of high density sensor technology for
the collection, detection, and discrimination of closely
related molecules or conditions,
2. Studies on the improvement of detection systems, ( e.g.,
development of more sensitive assays and rare event
monitoring techniques),
3. Development of laboratory or home based diagnostic systems to
evaluate individual patients or populations at risk,
4. Use of new, highly sensitive technologies to improve the
sensitivity to proteomic and genomic material in saliva, and
5. development of computer programs and algorithms for
acquisition and input of dissimilar sets of data, and for data
entry, storage and analysis.
Accomplishing these activities will require the participation of
multidisciplinary teams that will include investigators such as
biologists, chemists, technology developers, engineers, computer
scientists and clinicians.
The NIDCR anticipates that projects supported by this RFA may not
result directly in a commercial-grade product. However, a plan for
technology dissemination would strengthen the application. NIDCR will
not provide the substantial amount of funding that will likely be
required to support the commercialization. Since such additional
investment is likely to come from the private sector and because of the
important expertise available in the private sector to accomplish the
tasks required of such projects, its participation in projects is
encouraged, although not required.
SPECIAL REQUIREMENTS
In order to ensure maximum progress in the projects funded by this
initiative and to realize the maximum potential of saliva as a
diagnostic and monitoring fluid, several special activities will be
required of the funded investigators. The Principal Investigators are
expected to present a cost-effective plan to recruit and apply the
appropriate expertise needed to meet project goals and to shift
resources as requirements change. For example, substantial engineering
capacity may be required early in the project, but not later, while
device testing may be modest initially, but escalate later. The
research plan must describe how effective communication between the
various components will be established and maintained, the information
flow by which input from various perspectives will be gathered and used
to implement the research plan, and how decisions will be made on
resource deployment. Principal Investigators will be expected to attend
Steering Committee meetings (see below) and participate in conference
calls on a regular basis. Budget requests should include funds to
support travel of the PI and one other investigator to attend the
scheduled Steering Committee meetings. Restricted availability of
unique research resources, upon which further studies are dependent,
can impede the advancement of research and delivery of health care.
Thus, the NIH is interested in ensuring that the information about new
methods, technologies, and computer software that is developed through
this program becomes readily available to the research community for
further research and development, with the expectation that this will
eventually lead to information and products that improve the health of
the public. For this reason, applicants should develop and propose
specific plans for sharing the data, materials, and software generated
through the grant. These plans should be consistent with the policies
of their institutional offices of technology transfer. NIH has
developed guidance on developing such policies, information is
available at: (http://www.ott.nih.gov/policy/rt_guide_final.html).
The scientific review group will evaluate the adequacy of the proposed
plans for sharing data. Comments on the plan and any concerns will be
presented in an administrative note in the Summary Statement. The
adequacy of the plan will be considered by NIDCR program staff and will
be important in determining whether the grant shall be awarded. The
sharing plan as approved, after negotiation with the applicant when
necessary, will be a condition of the award. Evaluation of non-
competing continuation applications will include assessment of the
effectiveness and timeliness of research resource release.
Applicants are reminded that the grantee institution is required to
disclose each invention to NIH within two months after the inventor
discloses it in writing to grantee institutional personnel responsible
for patent matters.
TERMS AND CONDITIONS OF AWARD
These special Terms of Award are in addition to and not in lieu of
otherwise applicable OMB administrative guidelines, PHS regulations at
42 CFR Part 52 and DHHS grant administration regulations at 45 CFR
Parts 74 and 92, as applicable, and other DHHHS, PHS, and NIH Grant
Administration policy statements.
As stated above, the administrative and funding instrument used for
this program is a cooperative agreement (U01), an "assistance"
mechanism (rather than an "acquisition" mechanism) in which substantial
NIH scientific and/or programmatic involvement with the awardee is
anticipated during performance of the activity. Under the cooperative
agreement, NIDCR"s purpose is to work with the PI as a partner to
assist and stimulate planning and implementation. NIDCR will not
assume primary direction, responsibility, or a dominant operating role
in the research. The primary role and total responsibility for this
program resides with each Principal Investigator. The NIDCR, as noted
below, will share specific tasks and activities in completing the
agreement.
1. Awardee Rights and Responsibilities
o The PI will have primary authority and responsibility to define
objectives and approaches and to plan, conduct, analyze, and publish
results, interpretations, and conclusions of studies conducted under
the terms and conditions of the cooperative agreement award. In
addition, the PI agrees to follow the common protocols developed by the
Steering Committee.
o The PI will assume responsibility and accountability to the awardee
organization officials and to the NIDCR for the performance and proper
conduct of the research supported by the project in accordance with the
terms and conditions of the award.
o The PI will serve as a voting member of the Steering Committee, will
attend the Planning Meeting and two Steering Committee meetings in the
first year, and two Steering Committee meetings a year in subsequent
years.
o The PI will be responsible for sharing with the investigators funded
through this initiative and with the NIDCR staff: i) standardized
saliva and/or oral fluid samples and specific markers, ii) information
on new developments and/or methods for solving obstacles in
instrumentation design and development, and iii) knowledge on
regulatory issues related to the development and review by the Food and
Drug Administration (FDA) of the new diagnostic technologies.
o The PI will establish an Internal Advisory Committee to provide
scientific and administrative oversight. The Internal Advisory
Committee will be composed of the lead institute personnel, and other
technical or research personnel. The committee is expected to meet at
least monthly. Minutes of these meetings will be made available to
NIDCR staff upon request. The Internal Advisory Committee is charged
with both prioritizing projects and periodically reviewing the
different activities to ensure that the objectives outlined in the
application are being met.
o Awardees will retain custody of, and have primary rights to, the data
developed under these awards, subject to Government rights of access
consistent with current HHS and NIH policies.
o Upon completion of the project, the PI is expected to put all study
design materials and procedure manuals into the public domain and/or
make them available to other investigators, according to the approved
plan for making data and materials available to the scientific
community and the NIDCR, for the conduct of research at no charge other
than the costs of reproduction and distribution.
2. NIDCR Staff Responsibilities
The dominant role and prime responsibility for the project as a whole
resides with the awardees although specific tasks and activities in
carrying out the studies will be shared by awardees and the NIDCR. The
Institute will designate a Program Scientist who will have substantial
scientific-programmatic involvement during conduct of this activity.
Alternatively, the Program Director responsible for normal stewardship
may function as a Program Scientist.
The NIDCR Program Scientist will be a voting member of the Steering
Committee and its subcommittees.
o The NIDCR Program Scientist will be responsible for making additional
links among the engineering and instrumentation developers and the oral
biology scientist, use the information of the Steering committee to
coordinate and facilitate the research activities for the saliva/oral
fluid based diagnostic technologies, and attend and participate in all
meetings of the Steering Committee.
o NIDCR Program Scientist will help the Steering Committee to develop
and draft operating policies and policies addressing recurring
situations that require coordinated action.
o NIDCR will designate a Program Director and a Grants Management
Specialist to provide administrative oversight of the cooperative
agreement.
o The NIDCR Program Director will review the scientific progress of the
individual grants for compliance with operating policies developed by
the Steering Committee, and may recommend to the NIDCR to withhold
support, suspend, or terminate an award for lack of scientific progress
or failure to adhere to policies established by the Steering Committee.
o NIDCR reserves the right to require the transfer of appropriate
reagents, tools and pertinent data that are generated as the result of
participation in research supported under these awards to an eligible
third party, in order to advance the research. Collaborators supported
under these awards must be informed of this right.
o Support or other involvement of industry or any other collaborators
in any study performed by the awardees may be advantageous and
appropriate. However, except for licensing of patents or copyrights,
support or involvement of any third party will occur only following
notification to, and concurrence by the NIDCR.
3. Collaborative Responsibilities (Steering Committee)
o The NIDCR Program Scientist and PIs of the projects funded under this
RFA will be responsible for forming a Steering Committee as defined
below. The Steering Committee will act as the main governing board
that will review the progress of the research activities, develop
collaborative protocols, identify technological impediments to the
progress of prototype detection systems to "real-time" diagnostic
systems using saliva as a diagnostic medium, select strategies to
surmount them, and identify opportunities for sharing techniques and
tools developed within each individual project. The Steering Committee
will advise NIDCR Program Staff of scientific developments and
opportunities that may enhance the achievement of the program.
o The Steering Committee will be composed of the PI from each project
funded through RFA DE-02-002, and the NIDCR Program Scientist .The PI
from each project will have one vote and the NIDCR Program Scientist
will have one vote.
o The Steering Committee may, as it deems necessary, invite additional,
non-voting scientific advisors to meetings at which research priorities
and opportunities are discussed.
o There will be two meetings of the Steering Committee annually, both
in the Bethesda, MD area, at times agreed upon by the Steering
Committee and the NIDCR.
The first meeting of the PIs funded under this RFA will be a Planning
Meeting in the Bethesda, MD area soon after grants are awarded. At the
Planning Meeting the Steering Committee will be formed and select a
chairperson from among the members who represent the awardees. At the
Planning Meeting the Steering Committee may: (a) draft a charter to
detail policies and procedures and develop a process for monitoring
compliance with the policies and procedures and for recommending that
the NIDCR Program Director act on evidence of non-compliance with
Steering Committee policies, (b) agree upon the terms of the charter,
and (c) discuss the approaches that were proposed in the project
applications and any relevant new information, and set initial
priorities for the projects to be pursued.
4. Arbitration
Any disagreement that may arise on scientific and programmatic matters
within the scope of the cooperative agreement and between award
recipients and NIDCR may be brought to arbitration. An arbitration
panel will be composed of three members: one selected by the Principal
Investigator, a second member selected by NIDCR, and, the third member
selected by the two prior selected members. This special arbitration
procedure in no way affects the awardee"s right to appeal an adverse
action that is subject to appeal in accordance with PHS regulations at
42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16.
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 sub-populations must be included in all NIH-supported
clinical research projects unless a clear and compelling justification
is provided indicating that inclusion is inappropriate with respect to
the health of the subjects or the purpose of the research. This policy
results from the NIH Revitalization Act of 1993 (Section 492B of Public
Law 103-43).
All investigators proposing clinical research should read the AMENDMENT
"NIH Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html),
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH
definition of clinical research, updated racial and ethnic categories
in compliance with the new OMB standards, clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398, and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable, and b)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic
group differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS
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.
Investigators also may obtain copies of these policies from the program
staff listed under INQUIRIES. Program staff may also provide
additional relevant information concerning the policy.
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. This policy announcement is found
in the NIH Guide for Grants and Contracts Announcement dated June 5,
2000, at the following website:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.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. Reviewers are cautioned that
their anonymity may be compromised when they directly access an
Internet site.
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.
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, names of
other key personnel and, if applicable, participating institutions, as
well as the 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
subsequent applications, the information that it contains allows NIDCR
staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent to:
Eleni Kousvelari, DDS, D.Sc.
Chief, Cellular & Molecular Biology, Physiology
& Biotechnology Branch
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
Natcher Building, Room 4AN 18A
Bethesda, MD 20892-6402
Telephone: (301) 594-2427
FAX: (301) 480-8318
Email: [email protected]
APPLICATION PROCEDURES/SPECIAL INSTRUCTIONS
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: [email protected].
However, the form PHS 398 should be modified as follows. Biosketches
and "Other Support" pages should be included for all personnel. Page
limitations have been increased to a maximum of 40 pages from the usual
25 page limit for the "Research Plan" of an application. This 40 page
limit is an absolute maximum. However, applicants are encouraged to be
concise and use fewer pages. Budget pages, budget justifications,
material transfer agreements, and letters from collaborators and
consultants and their biosketches are not included in this page limit.
Applicants should divide the "Research Plan" into the following
sections:
o Description of the diagnostic area (autoimmune disease, periodontal
disease, identification of lethal agents, oral cancers etc.), for which
such a prototype will be developed,
o Description of the existing technology of which proof-of-principle
exists (status of the device/method prior to funding),
o Description of the design aspects/plans that will be completed during
the period of the award,
o Description of how the technologies to be developed will contribute
to automated, low cost, more efficient, and rapid simultaneous
biochemical analysis for multi-analyte detection.
In the last three sections listed above, the roles and expertise of all
key personnel, collaborators, and consultants who are associated with
this part of the application should be well documented. Applicants must
provide methods to maintain records, establish, standardize, and
distribute protocols and provide for quality control and budgetary
oversight. Applicants also should include the description of the
internal advisory board consisting of the Principal Investigator and
other key personnel that will oversee the daily operation of the
activities. Applicants should state their willingness to collaborate
and share data freely with the other investigators supported by this
RFA and the wider research community. Applicants should discuss their
willingness to serve on the Steering Committee and should state their
willingness to follow the common protocols that will be developed by
the Committee. Applicants should also describe how they would comply
with the involvement of NIDCR Program Scientists to work together
cooperatively.
BUDGET INSTRUCTIONS
Applicants who have additional funds to support ("leverage") the
proposed project should indicate the source of funds (institutional,
NIH grant number etc.) that permit them to accomplish the project
goals. Subcontract budgets should be a separate page, and the
subcontract indirect costs should be calculated and listed in the usual
place as part of the total costs of the budget.
Applicants must budget for travel and per diem expenses for
participation in the Steering Committee, subcommittees, workshops, and
symposia. Applicants should budget for at least two meetings in the
Bethesda, MD area each year.
The RFA label should be affixed to the bottom of the face page of the
application with the RFA number typed on the label. The RFA label is
available in the PHS 398 (rev. 5/2001) application form. 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.
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 to CSR, two additional copies of the
application must be sent to:
H. George Hausch, Ph.D.
Acting Director,
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
45 Center Drive, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone: (301) 594-2904
FAX: (301) 480-8303
Email: [email protected]
Applications must be received no later than April 11, 2002. 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
General Considerations
Applicants are encouraged to submit and describe their specific
concepts concerning the most appropriate means of accomplishing the
goals of the cooperative study. Applications are expected to address
issues identified under "SPECIAL REQUIREMENTS", "TERMS AND CONDITIONS
OF AWARD" and "SPECIAL INSTRUCTIONS". All applications will be judged
on the basis of the scientific merit of the proposed project and the
documented ability of the investigators to meet the RESEARCH OBJECTIVES
of the RFA. Although the technical merit of the proposed protocol is
important, it will not be the sole criterion for evaluation of a study.
Other factors considered to be important for review include
demonstrated expertise in technology development, a multi-disciplinary
team of collaborators, substantial interactions among collaborating
researchers, demonstration of appropriate facilities and resources,
willingness to share data and reagents freely.
Review Process
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NIDCR. Incomplete 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
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
Dental and Craniofacial Research Advisory Council.
Review Criteria
To ensure that the applications for this Program are evaluated
appropriately, the standard NIH review criteria have been adapted to be
more appropriate for proposals that are design- rather than hypothesis-
driven. The score should reflect the overall impact that the award
would have on the accomplishment of NIDCR"s goals, based on
consideration of the following five criteria. Each of these criteria
will be addressed and considered in assigning the overall score,
weighting them as appropriate for each application. 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 the goals of
this research program.
(1) Significance: Does this proposal address an important problem?
If the aims of the application are achieved, will the new technology
result in efficient and cost-effective accomplishment of diagnostic
technologies based on saliva and/or other oral fluids?
(2) Approach: Is the proposed approach likely to yield the desired
results? Has proof-of-principle of the underlying technology been
achieved? Are the advantages of the proposed technology over competing
technologies clearly articulated? Are the design principles clearly
articulated and likely to be achieved? Does the applicant acknowledge
potential problem areas and consider alternative tactics? Are plans in
place to monitor and document the quality of the products? Are plans
clearly in evidence and appropriate for establishing and maintaining
effective partnership between technology developers and experienced
users? Is the project timely and likely to remain at the state-of-the-
art level throughout the period of requested support? Are plans for
information dissemination and technology transfer adequate?
(3) Innovation: Does your project employ novel concepts, approaches
or methods? Are the aims original and innovative? Does your project
challenge existing paradigms or develop new methodologies or
technologies?
(4) Investigator: Are the experiences of the PI and team members
appropriate to the tasks and well balanced, and is there evidence of
firm commitment to the project from each of the key parties of the
collaboration? Is the PI capable of coordinating and managing the
proposed project? Is there evidence of interdisciplinary/
multidisciplinary collaborations? Is there evidence that the team
members can work together effectively? Do the PI and team members have
a track record of developing useful technology?
(5) Environment: Does the scientific and technological 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?
In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following, to
the extent that these issues pertain to a particular application:
o The adequacy of plans to include genders, minorities and their
subgroups, and children for the scientific goals of the research.
Plans for the recruitment and retention of subjects will also be
evaluated,
o The reasonableness of the proposed budget and duration in relation to
the proposed research,
o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the
project proposed in the application, and
o Provisions for the safety of the research environment.
Schedule
Letter of Intent Receipt Date: March 11, 2002
Application Receipt Date: April 11, 2002
Peer Review Date: May 2002
Council Review: August 2002
Earliest Anticipated Start Date: September 2002
AWARD CRITERIA
The following award criteria will be considered in making award
decisions:
o Quality of the proposed project as determined by peer review,
o Availability of funds, and
o Contribution to program goals.
INQUIRIES
Inquiries are encouraged. The opportunity to clarify any issues or
questions from potential applicants is welcome.
Direct inquiries regarding programmatic issues to:
Eleni Kousvelari, DDS, D.Sc.
Chief, Cellular & Molecular Biology, Physiology
& Biotechnology Branch
Division of Basic & Translational Sciences
National Institute of Dental & Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-18A
Bethesda, MD 20892-6402
Telephone: 301-594-2427
Fax: 301-480- 8318
Email: [email protected]
Direct inquiries regarding fiscal matters to:
Martin R. Rubinstein
Grants Management Officer
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN-38
Bethesda, MD 20892-6402
Telephone: (301) 594-4800
Fax: (301) 480-8301
email: Martin.Rubinstein@ nih.gov
AUTHORITY AND REGULATIONS
This program is described in the Catalog of Federal Domestic Assistance
No. 93.121, Oral Diseases and Disorders Research Awards. 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 and Federal Regulations 42 CFR 52 and 45 CFR Parts 74
and 92. This program is not subject to the intergovernmental review
requirements of Executive Order 12372 or Health Systems Agency review.
The PHS strongly encourages all grant 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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