PATHOBIOLOGY OF TEMPOROMANDIBULAR JOINT DISORDERS
RELEASE DATE: September 4, 2002
RFA: DE-03-005
National Institute of Dental and Craniofacial Research (NIDCR)
(http://www.nidr.nih.gov/)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
(http://www.niams.nih.gov/)
Office of Research on Women"s Health (ORWH)
(http://www4.od.nih.gov/orwh/)
LETTER OF INTENT RECEIPT DATE: October 20, 2002
APPLICATION RECEIPT DATE: November 20, 2002
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanisms 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 Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations:
PURPOSE OF THIS RFA
The purpose of this initiative is to stimulate cross-cutting,
integrative research aimed at delineating the mechanisms underlying the
etiology and pathogenesis of the orofacial structures associated with
Temporomandibular Joint Disorders (TMJDs). The ultimate goal of this
initiative is a systems approach, from the gene, molecule, cell to
tissue, and organ, that will provide the basis to better understand
TMJDs and lead to the development of new insights into treatment and
management of these disorders. In the context of this initiative,
integrative research is defined as the combined use of approaches from
several different scientific disciplines such as cell biology,
physiology, neurobiology, neuroendocrinology, genetics, molecular
biology and imaging technologies to probe developmental, neurological,
endocrine, immune and other relevant systems in order to define the
mechanisms underlying the etiology and pathogenesis of TMJDs.
RESEARCH OBJECTIVES
Background
TMJDs refer to a collection of medical and dental conditions affecting
the Temporomandibular Joint (TMJ) and the muscles of mastication, as
well as contiguous tissue structures. Pain in the masticatory muscles,
in the TMJ, and in the associated hard and soft tissues and limitation
in jaw function and sounds in the TMJ are common symptoms.
Epidemiological data suggest that approximately 10.8 million American
adults experience symptoms associated with TMJDs. It has been shown
that the disorder is 1.5-2 times more prevalent in women than in men
and that 80 present of the patients treated for TMJDs are women. Given
the variation among the problems labeled TMJDs, it is not surprising
that the etiology and pathogenesis of TMJDs are still unclear. This
initiative is structured to address the complexity of the underlying
genetic, cellular and molecular mechanisms of the different tissues
(mandibular condyles, the mandibular fossa and articular eminence of
the temporal bone, articular disc, ligaments, muscles of mastication
and vascular tissues) as well as peripheral and central neural
processes associated with TMJDs. Moreover, the use of contemporary
biomedical techniques such as biocomputing for modeling the different
components of the TMJ and advanced imaging techniques are encouraged.
The elucidation of the developmental events leading to the formation of
the TMJ can provide an understanding of the contribution(s) of each of
the TMJ components in the pathogenesis associated with TMJDs. In humans
the TMJ develops from the neural crest derived ectomesenchymal
blastemas. Differentiation of the embryonic mesenchyme to form the
primitive TMJ cavity occurs at about the twelfth week of embryonic
development. Interestingly, the mandibular condyles develop as
secondary cartilage from a proliferative layer of progenitor cells that
turn into extracellular matrix producing chondrocytes that are
eventually replaced by osteoblasts. This particular developmental
origin explains, in part, the lack of articular cartilage and the
presence of a fibrous articular tissue cap in its place. Although in
recent years there has been significant progress in understanding the
putative regions and the signaling networks controlling the outgrowth
and development of the mandible, the precise developmental mechanisms
by which the TMJ as a unit is formed are unclear. Obviously more
research is needed to decipher the molecular mechanisms regulating
development and morphogenesis of the TMJ. Such knowledge is fundamental
in understanding the contribution(s) of each of the TMJ components in
the pathogenesis of TMJDs as well as understanding the pathogenesis of
several abnormalities and congenital syndromes. For example,
abnormalities in the mandibles of various mouse mutants caused by
targeted inactivation of individual and multiple candidate molecules
provide powerful tools to examine not only the hierarchy of the
signaling mechanisms and molecules involved but also the specific
abnormalities that the inactivation of candidate genes may cause in the
formation of each TMJ component (i.e., condyle, coronoid, and angular
process of the mandible) and in the formation of the TMJ as a unit.
The structures of the TMJ that are mainly shown to be associated with
TMJDs are the temporomandibular joint disc, the ligaments and the
masticatory muscles. Although there have been tremendous advances
concerning the understanding of the cell biology, physiology and
molecular genetics of skeletal, and to some extent the orofacial
muscles, there is a paucity of information regarding the
pathophysiology of orofacial muscles (masticatory and facial muscle).
The lack of such information makes it difficult to delineate the
molecular basis for repair of the masticatory muscle systems as well as
elucidate the normal function of muscle cells when affected by
inflammatory processes (e.g., do they express surface molecules or
release soluble mediators or structural components that may activate an
immune or inflammatory response?).
To date it remains unclear what additional mediator mechanisms and
molecules are associated with orofacial muscle pathophysiology. The
only information to date derives from analysis of TMJ synovial fluid.
Molecules such as serotonin (5-HT), Prostaglandin E2, (PGE2) and
leukotriene B4 that are known to be associated with
hyperalgesia/allodynia of the masseter muscle in patients with
fibromyalgia have been detected in the synovial fluid of arthritic TMJ.
Cytokines such as interleukin-1 (IL-1), intrerleukin-6 (IL-6) ?and
tumor necrosis factor ???TNF?) have also been found in the synovial
fluid of arthritic TMJs as have neuropeptides such as substance P,
calcitonin gene-related peptide (CGRP) and neuropeptide Y (NPY).
Degradation markers of the articular disc such as keratan sulfate and
proteoglycans are also present in this arthritic joint. The
contribution of these molecules to pathogenesis and clinical expression
of TMJDs remains uncertain. New imaging methodologies as well as
improved animal models will help to elucidate the inflammatory
processes that are involved in response to injury, as well as the
contribution of the nervous system to inflammatory diseases of TMJ
structures.
As with other synovial joints, the TMJ is subject to external
loading and to constraints that are imposed on soft tissues such
as the ligaments, the articular disc, the fibrous capsule
(fibrocartilage) and the temporal bone. During joint motion the
ligaments, articular disc and the fibrous capsule are deformed
and are incapable of further movement. Both the ligaments and the
fibrous capsule of the joints are richly innervated by sensory
(afferent) neurons that are stimulated by motion. Other sensory
neurons found in the soft tissues of the TMJ are nociceptors,
neurons that mediate the sensation of pain. It is important to
expand the knowledge of the function of sensory neurons (sensory
afferent) that are stimulated by motion as well as those
nociceptors associated with TMJDs. To date, pharmacological and
physiological studies have shown that disordered sensory
processing arises from changes in sensory afferent function and
organization of sensory neurons. Agents such as growth factors
and cytokines induce pronounced changes in the expression of a
variety of functional proteins including receptors and ion
channels in the affected afferent axons and sensory neurons. The
lack of targeted effective pharmacological agents available for
the treatment of pain reflects our incomplete understanding of
the mechanisms associated with TMJDs and orofacial pain
processing. Therefore, the design of better preventive and
therapeutic interventions for TMJD neuropathic pain is dependent
on the expansion of our knowledge of the molecular mechanisms of
pain. The development of improved animal models can provide new
tools to elucidate TMJD associated pain and orofacial pain
processing. Sensitivity to pain and inhibition of pain are traits
subject to considerable variability, both clinically and
experimentally. As mentioned before, women make up the majority
of patients treated with TMJDs. Therefore, it is important to
examine the role of gender difference in the frequency and
severity of TMJD associated pain and the response to analgesics.
Scope
The objectives and scope of this initiative are the application of a
systematic multidisciplinary research approach to the elucidation the
pathobiology and pathophysiology of the TMJ diseases and disorders. It
is envisioned that the scientific knowledge gained though studies
supported by this initiative will lead to the development of
therapeutic strategies for these disorders.
The following are some examples of potential research areas:
o Utilization of laser capture and microarray technologies for
profiling/fingerprinting of TMJ structures including muscles, tendons
and nerves in experimental conditions of TMJDs.
o Identification of the cellular and molecular events leading to
remodeling of the components of the TMJ to adapt to biomechanical
changes.
o Elucidation of gender influences associated with TMJDs and orofacial
pain.
o Development of computer/mathematical modeling systems for the
evaluation of anatomy and physiology of facial and TMJ structures and
for the prediction of pathological changes.
o Generation of knockout and transgenic animals, subtraction cloning
and differential screening for the definition of developmental pathways
that may indicate differences in TMJ function and pain sensitivity.
o Development of animal models for the identification of pain
modulators, for the examination of pain modulation circuitry attributed
to inflammation and for the examination of possible overlap between
TMJD associated pain and pain associated with other painful pathologies
such as osteoarthritis, rheumatoid arthritis and fibromyalgia.
o Development of model systems to understand the inflammatory
mechanisms leading to extracellular matrix degeneration in TMJDs as
well as the role of sex-specific hormones (e.g., estrogens) in
cartilage and bone degeneration.
o Identification of cell (e.g., neutrophils, macrophages, Langerhans
cells), inflammatory mediators, (e.g., cytokines TNF?, IL-1, IL-6) and
signal transduction mechanisms leading to inflammatory neuropathies
associated with TMJDs (e.g., osteoporosis, osteoarthritis).
o Use of genomic and proteomic analytical approaches to define the
characteristics and molecular responses of normal versus diseased TMJ
tissues for the discovery of novel regulators required for normal
function.
o Identification of specific biomarkers that can be used to predict
risk, aid in earlydiagnosis, and assess progression and evaluation of
TMJDs.
o Utilization of innovative imaging technologies (e.g., high field/high
resolution methods) to define the processing of nociceptive (pain)
information from craniofacial musculoskeletal tissue.
o Development of molecular imaging probes and contrast agents based on
biological markers for in vivo imaging of biological processes, for
discovering, understanding, and diagnosing TMJDs as well as clarifying
molecular and cellular aspects of muscle degeneration in inflammation.
The National Institute of Arthritis and Musculoskeletal and Skin
Diseases (NIAMS) invites investigator-initiated research applications
for ancillary studies to existing clinical studies of patients with
rheumatoid arthritis and juvenile rheumatoid arthritis to investigate
temporomandibular involvement in these diseases. Specifically, the
applications should focus on the utilization of patients and patient
materials from such studies for: i) the evaluation of prevalence and
clinical presentation of temporomandibular involvement in these
diseases, ii) surrogate markers of disease activity, iii) genetic
markers, iv) and therapeutic effects. The parent or core clinical
study must have independent financial support and will NOT receive
support under this RFA.
MECHANISM OF SUPPORT
This RFA will use the NIH Research Project Grant (R01). 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 July 30, 2003.
This RFA uses just-in-time concepts. Applications for the R01
mechanism use the modular budgeting formats (see
https://grants.nih.gov/grants/funding/modular/modular.htm). An R01
applicant may request a project period of up to 4 years and a budget
for direct costs of up to $250,000 per year.
FUNDS AVAILABLE
The NIDCR intends to commit approximately $3,000,000 in FY 2003 to fund
10-12 new grants in response to this RFA. The NIAMS intends to commit
approximately $300,000 in FY 2003 to fund one new grant in response to
this RFA.
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 FY 2003 financial
plans of the NIDCR and NIAMS provide support for this program, awards
pursuant to the 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 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 National laboratories
o Units of state and local governments
o Eligible agencies of the Federal government
o Domestic or foreign
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 questions about scientific/research issues to:
Eleni Kousvelari, DDS, D.Sc.,
Chief, Cellular & Molecular Biology, Physiology
& Biotechnology Branch
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45 Room 4AN-18A
Bethesda, MD 20892
Telephone: (301) 594-2427
FAX: (301) 480-8318
Email: Kousvelari@de45.nidr.nih.gov
Bernadette Tyree, Ph.D.
Director, Cartilage and Connective Tissue Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health
6701 Democracy Blvd., Rm. 884
Bethesda, MD 20892
Telephone: (301) 594-5032
FAX: (301) 480-4543
Email: bt16w@nih.gov
o Direct your questions about peer review issues 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: George.Hausch@nih.gov
Direct your questions about financial or grants management matters to:
Robert L. Tarwater,
Grants Management Specialist
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
Building 45, Room 4AN32A
45 Center Drive
Bethesda, Maryland 20892-6402
Telephone: (301) 594-4836
FAX: (301) 480-8301
Email: tarwater@nih.gov
Melinda Nelson
Grants Management Officer
Grants Management Branch
National Institute of Arthritis and Musculoskeletal and Skin Diseases
National Institutes of Health
6701 Democracy Blvd., Rm. 884
Bethesda, MD 20892
Telephone: (301) 594-3535
FAX: (301) 480-4543
EMAIL nelsonm@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 NIDCR 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. It is preferred that the letter of intent be sent
electronically to Kousvelari@de45.nidr.nih.gov If necessary, the letter
of intent can be sent by regular mail to Dr. Eleni Kousvelari, listed
in the WHERE TO SEND INQUIRIES section of this announcement.
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). The PHS 398 is
available at https://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267,
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
https://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
https://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:
https://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:
Dr. H. George Hausch
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
APPLICATION PROCESSING: Applications must be received by 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.
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.
PEER 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. And, if the
application is not responsive to the RFA, CSR 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 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 the appropriate Institute
Advisory Council.
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
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 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 you appropriately trained and well suited to
carry out this work? Is the work proposed appropriate to your
experience level as the principal investigator and to that of other
researchers (if any)?
(5) ENVIRONMENT: Does the scientific environment in which your 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?
ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your
application will also be reviewed with respect to the following:
o PROTECTIONS: 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.
o INCLUSION: 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 included in the section on Federal Citations,
below).
o 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: October 20, 2002
Application Receipt Date: November 20, 2002
Peer Review Date: February/March 2003
Council Review: May/June 2003
Earliest Anticipated Start Date: July 30, 2003
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
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 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
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html),
a complete copy of the updated Guidelines are available at
https://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
https://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
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of
research on hESCs can be found at
https://grants.nih.gov/grants/stem_cells.htm and at
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.
Only research using hESC lines that are registered in the NIH Human
Embryonic Stem Cell Registry will be eligible for Federal funding (see
http://escr.nih.gov). It is the responsibility of the applicant to
provide the official NIH identifier(s)for the hESC line(s)to be used in
the proposed research. Applications that do not provide this
information will be returned without review.
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
https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.
Applicants may wish to place data collected under this initiative 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.
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.health.gov/healthypeople.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance No. 93.121 (NIDCR) 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
https://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.