and Human Services (HHS)
EXPIRED
Department of Health and Human Services
Participating Organizations
National
Institutes of Health (NIH), (http://www.nih.gov)
Components of Participating Organizations
National Institute of Dental and Craniofacial Research (NIDCR), (http://www.nidcr.nih.gov)
National
Institute on Deafness and other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.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://orwh.od.nih.gov/)
Title: Temporomandibular Joint and Muscle Disorders:
Pathophysiological Mechanisms Linking Comorbid Conditions (R01)
Announcement Type
New
Update: The following update relating to this announcement has been issued:
Looking ahead: As part of the Department of Health and Human Services' implementation of e-Government, during FY 2006 the NIH will gradually transition each research grant mechanism to electronic submission through Grants.gov and the use of the SF 424 Research and Related (R&R) forms. Therefore, once the transition is made for a specific grant mechanism, investigators and institutions will be required to submit applications electronically using Grants.gov.. For more information and an initial timeline, see http://era.nih.gov/ElectronicReceipt/. NIH will announce each grant mechanism change in the NIH Guide to Grants and Contracts (http://grants.nih.gov/grants/guide/index.html). Specific funding opportunity announcements will also clearly indicate if Grants.gov submission and the use of the SF424 (R&R) is required. Investigators should consult the NIH Forms and Applications Web site (http://grants.nih.gov/grants/forms.htm) for the most current information when preparing a grant application.
Program Announcement (PA) Number: PA-06-188
Catalog of Federal Domestic Assistance Number(s)
93.121
(NIDCR), 93.173 (NIDCD), 93.853 (NINDS), 93.846 (NIAMS)
Key Dates
Release Date: March 1, 2006
Application
Submission Dates(s):
Standard dates apply, please
see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details.
Peer
Review Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Council
Review Date(s): Standard
dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward for details.
Earliest
Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm for details.
Additional Information To Be Available Date (Url
Activation Date): Not
applicable
Expiration Date for R01 Non-AIDS Applications: November 2, 2006
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007
Due Dates for E.O. 12372
Not Applicable
Additional Overview
Content
Executive Summary
The purpose of this program announcement is to stimulate research on discovering etiological and pathophysiological mechanisms underlying a set of chronic, comorbid conditions associated with temporomandibular joint and muscle disorders (TMJMDs). TMJMDs are a complex collection of diseases involving one or more tissues of the TMJ and facial musculature. Primary symptoms include chronic pain in facial muscles and limited and painful movement of the jaw. In addition, these and other symptoms of TMJMD can occur together with other chronic illnesses such as fibromyalgia, atypical face pain, trigeminal neuralgia, chronic fatigue syndrome, multiple chemical sensitivity, irritable bowel syndrome, complex regional pain syndrome, migraine headache, speech hearing, swallowing, balance, smell, and taste disorders, and certain cardiovascular diseases. This program announcement seeks research applications that use state-of-the-art, multidisciplinary and interdisciplinary approaches to discover molecular, physiological, and behavioral mechanisms responsible for the overlapping symptoms manifested in the set of disorders that may co-exist with TMJMD. These applications may have as their research focus the chronic, comorbid conditions themselves or TMJMDs, provided that the aims and goals of the project are to discover biological mechanisms linking the comorbidities. While the overarching goal of this announcement is to arrive at a better understanding of potential mechanisms underlying TMJMDs as related to the variety of comorbidities associated with them, it is expected that no single research project will be able to accomplish this. Applicants are, therefore, encouraged to focus their attention on a particular pathway and a specific disease that is comorbid with TMJMD.
Table of Contents
Part
I Overview Information
Part
II Full Text of Announcement
Section
I. Funding Opportunity Description
1. Research Objectives
Section
II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section
III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
B. Eligible Individuals
2.Cost Sharing or Matching
3. Other - Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Address to Request Application
Information
2. Content and Form of Application
Submission
3. Submission Dates and Times
A. Submission, Review and
Anticipated Start Dates
1. Letter of
Intent
B. Sending an Application to
the NIH
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements
Section
V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research Resources
3. Anticipated Announcement and Award
Dates
Section
VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy
Requirements
3. Reporting
Section
VII. Agency Contact(s)
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/ Grants Management Contact(s)
Section
VIII. Other Information - Required Federal Citations
Part II
- Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Nature of the research opportunity - The purpose of this Program Announcement is to encourage research leading to the discovery of possible etiological and pathophysiological mechanisms underlying a set of chronic disorders that may overlap with temporomandibular joint and muscle disorder (TMJMD). Investigators with expertise in TMJMD and those with specific expertise in research areas related to the overlapping, comorbid conditions are encouraged to work together in carrying out cutting-edge research projects designed to uncover biological mechanisms responsible for comorbidities associated with TMJMD.
TMJMDs are a complex set of diseases involving one or more tissues of the face and TMJ. The primary symptoms of TMJMD may include chronic pain in facial muscles and limited and painful movement of the jaw. In addition, these and other symptoms of TMJMD may occur together with other chronic disorders such as fibromyalgia; atypical facial pain; trigeminal neuralgia; chronic fatigue syndrome; multiple chemical sensitivity; irritable bowel syndrome; sleep disorders; complex regional pain syndrome; migraine headache; speech, hearing (including tinnitus) swallowing, balance, smell, and taste disorders; affective disorders; and certain cardiovascular diseases. The possible overlap of these other conditions with TMJMD suggests several possibilities: TMJMD coexists with other chronic diseases; TMJMD is the somatization of one or more of these conditions; TMJMD results from effects of the other chronic disorders; and/or TMJMD contributes to these other conditions.
This initiative seeks research applications that will use multidisciplinary and interdisciplinary approaches to sort out these possibilities by discovering molecular, physiological, and behavioral mechanisms responsible for the overlapping symptoms and disorders that may coexist with TMJMD. These applications may have as their research focus the chronic, comorbid conditions themselves or TMJMDs, provided that the aims and goals of the project are to discover biological mechanisms linking the comorbidities. While the overarching goal of this announcement is to arrive at a full understanding of the mechanisms underlying TMJMDs and the variety of comorbidities associated with them, it is expected that no single research project will be able to accomplish this. Applicants, therefore, are encouraged to focus their attention on a particular pathway and a specific disease that is comorbid with TMJMD.
Background TMJMD is a complex heterogeneous disease. It likely represents a collection of disorders with varying etiologies, affecting the tissues of the masticatory muscles and the temporomandibular joint. Due to this complexity and our lack of a complete understanding of the underlying mechanisms of disease onset and progression, the treatment of some patients with TMJMD currently is less than satisfactory. The etiology of complex disorders like TMJMD may involve the interaction of genetic and environmental influences. In addition, it may be appropriate to view TMJMD as a biopsychosocial disorder, not only when considering diagnosis and treatment, but also in the context of pathological mechanisms associated with the disease and other diseases that may coexist with TMJMDs as comorbidities. Peripheral defects in muscle function, abnormal neurotransmission, central integration of sensory and motor inputs, and the societal and cognitive influences on these processes, may all interact and influence the disease process and expression of the associated comorbidities.
The major symptoms of TMJMD are chronic myofacial pain particularly in the muscles of mastication, restricted range of jaw motion, jaw locking, and abnormal popping and clicking noises in the TMJ, although this latter symptom is not, by itself, either predictive or diagnostic of TMJMD. In addition, other symptoms are known to occur in this disorder such as pain in the joint itself and in the area surrounding and radiating from the joint including the ear, neck, shoulder, and back; vertigo/balance problems; hearing loss, tinnitus; taste and smell problems; chronic headache; blurred or double vision; sleep disturbances; and difficulty in swallowing and/or speech. Besides these symptoms, certain psychiatric disturbances (psychopathologies) may be associated with TMJMD and may include depression, anxiety disorders, and substance abuse. While these other symptoms and conditions are clearly not diagnostic of TMJMD, they are associated with other chronic painful disorders and may have an important role in developing treatment approaches for TMJMD patients. For example, similar psychiatric disorders have been associated with TMJMD, fibromyalgia (FM), chronic fatigue syndrome (CFS), and irritable bowel syndrome (IBS). Interestingly, the psychiatric disorders are most often associated with the myogenous form of TMJMD (i.e. TMJMD characterized by chronic muscle pain) and may reflect the effects of prolonged chronic pain on the emotional status of the individual.
TMJMD patients often present with symptoms of other chronic painful conditions, such as FM, CFS, IBS, multiple chemical sensitivities, and cardiovascular abnormalities to name a few. As an example, both TMJMD and FM patients suffer from similar symptoms: muscle pain or tenderness, sleep disturbances, debilitating headaches, and difficulty in concentrating. The degree of overlapping symptoms and comorbid conditions is not trivial. Studies suggest that between 13 and 18% of TMJMD patients meet the diagnostic criteria for FM. Conversely, about 75% of FM patients meet the criteria for myofacial TMJMD. Patients with IBS have been diagnosed at similar rates with comorbid TMJD (16%), CFS (14%), and FM (28-65%). While some of the apparent comorbidity may be due to diagnostic ambiguity, it is clear that patients with these disorders have similar and multiple symptoms that characterize the various disorders.
It is important to understand the basis for the links between these comorbidities in order to develop more effective treatment and possible prevention strategies for TMJMD. However, the etiological and pathological mechanisms linking TMJMD and these comorbid conditions are unclear. In general they may involve abnormal responses of common homeostatic mechanisms, i.e. processes that help the body to return to original set points after a disruptive stimulus. Alternatively, or in addition, the mechanisms may relate to allostatic processes, i.e. the adaptation to new set points in the continued presence of a stimulus or an altered environment. In addition, failed or repeated allostatic processes, i.e. the allostatic load, may account for these comorbidities. Most of these regulatory systems control a systemic, physiological response and a central behavioral, response.
The concept of faulty adaptive processes is in agreement with a shift in thinking in recent years to a more central nervous system focus as the cause of TMJMD (excluding TMJMD associated with traumatic injury) rather than simply a peripheral one employing local homeostatic mechanisms. An additional consideration is that there is an increased prevalence of these comorbid disorders in women, indicating that sex steroids and gender may play an important, but complex role in the common pathophysiology. For example, there is an increased prevalence of TMJMD and FM in women, yet TMJMD patients are usually in their childbearing years while FM is usually diagnosed later in life. Regardless of the mechanisms responsible for the comorbidities associated with TMJMD, a more precise determination of the phenotypes of the diseases will be critical in order to clearly identify subsets of TMJMD patients and the specific comorbid conditions associated with TMJMD.
While several distinct pathological mechanisms may account for the comorbidities seen in association with TMJMD, many seem to ultimately involve abnormal functioning of feedback circuits (both positive and negative). These may include disturbances in the following: the hypothalamic-pituitary-adrenal (HPA) axis, the classical stress-response system; immune and neuroimmune function; centrally regulated biological clocks; autonomic nervous system function; and specific neurotransmitter system regulation. These and other mechanisms may work alone or in concert to cause the collection of comorbid conditions associated with TMJMD.
The cooperation of researchers with a common interest in TMJMD and those with specific expertise in research areas related to the overlapping comorbid conditions and symptoms found in TMJMD is needed in order to arrive at definitive answers to the underlying mechanisms involved in TMJMD and the variety of comorbidities noted. Information from the fields of neurology, psychiatry, cardiology, genomics, endocrinology, epidemiology, rheumatology, and communicative disorders, to name a few, will be required to develop and test hypotheses relating to the mechanisms that can account for the cluster of comorbidities. Technical expertise in behavioral science, genomic and proteomic approaches, biomedical imaging, electrophysiology, and molecular biology will be necessary to carry out cutting-edge experiments designed to uncover biological mechanisms responsible for overlapping symptoms and comorbid conditions associated with TMJMD. While the overarching goal of this announcement is to arrive at a clearer understanding of the mechanism underlying TMJMD and the variety of comorbidities associated with it, it is expected that no single research project will be able to accomplish this. Applicants are, therefore, encouraged to focus their attention on a particular pathway and a specific disease that is comorbid with TMJMD.
Scientific knowledge to be achieved - This Program Announcement will stimulate research that will increase our knowledge of the etiological and pathological mechanisms underlying comorbidity in somatic syndromes like TMJMD. It will be important to identify the regulatory systems and the altered functions of these systems that are important in the expression of comorbidity. Knowledge of both physiological and behavioral responses that are central in eliciting comorbidity will be gained; the molecules and cellular pathways underlying these responses will be identified as well.
Objectives of this research program - The objectives of this Program Announcement are to stimulate research that will: 1) identify molecules, cellular pathways, physiologies, and behaviors that are responsible for comorbid conditions that may be associated with TMJMD; 2) determine the pathogenic mechanisms by which these factors lead to the comorbidities; 3) determine molecules and pathways that may serve as novel therapeutic targets aimed at treating these comorbid conditions and/or preventing them; 4) identify biomarkers or diagnostics that will differentiate refractory TMJMD and comorbid conditions from those disorders which spontaneously remit or are successfully treated by conventional means.
Identify types of research and experimental approaches that are being sought - This Program Announcement seeks applications that will use basic, behavioral, epidemiological, and clinical research approaches in order to define causative factors and characterize pathogenic mechanisms that may be shared between comorbid conditions and TMJMD. This Announcement seeks a broad range of experimental approaches to this problem and may include clinical, molecular, cellular, and animal studies. The use of global approaches such as a systems biology approach and the utilization of genomic and proteomic techniques also are encouraged. Investigators with expertise in the fields of neurobiology, immunology, neurochemistry, endocrinology, rheumatology, cognitive and behavioral neuroscience, sensory and motor systems, neurology, and bioinformatics will be needed to discover biological mechanisms underlying comorbidity.
Examples of research topics Examples of research topics may include, but are not limited to the following, as they relate to TMJMD and comorbidities:
See Section
VIII, Other Information - Required Federal Citations, for policies related
to this announcement.
Section
II. Award Information
1. Mechanism(s) of Support
This funding
opportunity will use the R01 award mechanism.
As an applicant, you
will be solely responsible for planning, directing, and executing the proposed
project.
This funding opportunity
uses just-in-time concepts. It also uses the modular as well as the non-modular
budget 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 described in the PHS
398 application instructions. Otherwise follow the instructions for non-modular
research grant applications.
2. Funds Available
Because the nature and
scope of the proposed research will vary from application to application, it is
anticipated that the size and duration of each award will also vary. Although
the financial plans of the Institutes and Centers (ICs) provide support for
this program, awards pursuant to this funding opportunity are contingent upon
the availability of funds and the receipt of a sufficient number of meritorious
applications.
Facilities and
administrative costs requested by consortium participants are not included in
the direct cost limitation, see NOT-OD-05-004.
Section
III. Eligibility Information
1. Eligible Applicants
1.A. Eligible Institutions
You may submit (an)
application(s) if your organization has any of the following characteristics:
1.B. Eligible Individuals
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.
2. Cost Sharing or Matching
Cost sharing is not
required.
The most current Grants
Policy Statement can be found at: http://grants.nih.gov/grants/policy/nihgps_2003/nihgps_Part2.htm#matching_or_cost_sharing
3. Other-Special Eligibility Criteria
Section
IV. Application and Submission Information
1. Address to Request Application Information
The PHS 398 application
instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html
in an interactive format. Applicants must use the currently approved version of
the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
Telecommunications for
the hearing impaired: TTY 301-451-5936.
2. Content and Form of Application Submission
Applications must be
prepared using the most current PHS 398 research grant application instructions
and forms. Applications must have a D&B Data Universal Numbering System
(DUNS) number as the universal identifier when applying for Federal grants or
cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/.
The D&B number should be entered on line 11 of the face page of the PHS 398
form.
The title and number of this funding opportunity must
be typed on line 2 of the face page of the application form and the YES box
must be checked.
Foreign Organizations
Several special provisions apply to applications
submitted by foreign organizations:
Proposed
research should provide a unique research opportunity not available in the U.S.
3. Submission Dates and Times
See Section IV.3.A for details.
3.A.
Submission, Review and Anticipated Start Dates
Application Submission
Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm
Peer Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council
Review Date(s): http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s):http://grants1.nih.gov/grants/funding/submissionschedule.htm
3.A.1. Letter of Intent
A letter of intent is
not required for the funding opportunity.
3.B. Sending an
Application to the NIH
Applications must be
prepared using the research grant application forms found in the PHS 398
instructions for preparing a research grant application. Submit a signed,
typewritten original of the application, including the checklist, and five
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 (U.S. Postal Service Express
or regular mail)
Bethesda, MD 20817 (for express/courier service;
non-USPS service)
Personal deliveries of
applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).
3.C.
Application Processing
Applications must be submitted on or before the application
receipt/submission dates described above (Section
IV.3.A.) and at http://grants.nih.gov/grants/dates.htm.
Upon receipt
applications will be evaluated for completeness by CSR. Incomplete applications
will not be reviewed.
The NIH will not accept
any application in response to this funding opportunity that is essentially the
same as one currently pending initial merit review unless the applicant
withdraws the pending application. The NIH will not accept any application that
is essentially the same as one already reviewed. This does not preclude the
submission of a substantial revision of an application already reviewed, but
such application must include an Introduction addressing the previous critique.
Although there is no
immediate acknowledgement of the receipt of an application, applicants are
generally notified of the review and funding assignment within eight (8) weeks.
4. Intergovernmental Review
This initiative is not
subject to intergovernmental
review.
5. Funding Restrictions
All NIH awards are
subject to the terms and conditions, cost principles, and other considerations
described in the NIH Grants Policy Statement. The Grants Policy Statement can
be found at http://grants.nih.gov/grants/policy/policy.htm.
Pre-Award Costs are
allowable. A grantee may, at its own risk and without NIH prior approval, incur
obligations and expenditures to cover costs up to 90 days before the beginning
date of the initial budget period of a new or competing continuation award if
such costs: are necessary to conduct the project, and would be allowable under
the grant, if awarded, without NIH prior approval. If specific expenditures
would otherwise require prior approval, the grantee must obtain NIH approval
before incurring the cost. NIH prior approval is required for any costs to be
incurred more than 90 days before the beginning date of the initial budget
period of a new or competing continuation award.
The incurrence of pre-award costs in anticipation of a
competing or non-competing award imposes no obligation on NIH either to make
the award or to increase the amount of the approved budget if an award is made
for less than the amount anticipated and is inadequate to cover the pre-award
costs incurred. NIH expects the grantee to be fully aware that pre-award costs
result in borrowing against future support and that such borrowing must not
impair the grantee's ability to accomplish the project objectives in the
approved time frame or in any way adversely affect the conduct of the project.
See NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.
6. Other Submission Requirements
Specific
Instructions for Modular Grant applications.
Applications requesting
up to $250,000 per year in direct costs must be submitted in a modular budget
format. The modular budget 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 at http://grants.nih.gov/grants/funding/phs398/phs398.html
includes step-by-step guidance for preparing modular budgets. Applicants must
use the currently approved version of the PHS 398. Additional information on
modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm.
Specific Instructions for Applications Requesting $500,000 (direct costs) or More per Year.
Applicants requesting
$500,000 or more in direct costs for any year must carry out the following
steps:
1) Contact the IC
program staff at least 6 weeks before submitting the application, i.e., as you
are developing plans for the study;
2) Obtain agreement
from the IC staff that the IC will accept your application for consideration
for award; and,
3) Include a cover letter with the application that
identifies the staff member and IC who agreed to accept assignment of the
application.
This policy
applies to all investigator-initiated new (type 1), competing continuation
(type 2), competing supplement, or any amended or revised version of these
grant application types. Additional information on this policy is available in
the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html.
Plan for Sharing Research
Data
The precise content of
the data-sharing plan will vary, depending on the data being collected and how
the investigator is planning to share the data. Applicants who are planning to
share data may wish to describe briefly the expected schedule for data sharing,
the format of the final dataset, the documentation to be provided, whether or
not any analytic tools also will be provided, whether or not a data-sharing
agreement will be required and, if so, a brief description of such an agreement
(including the criteria for deciding who can receive the data and whether or
not any conditions will be placed on their use), and the mode of data sharing
(e.g., under their own auspices by mailing a disk or posting data on their
institutional or personal website, through a data archive or enclave).
Investigators choosing to share under their own auspices may wish to enter into
a data-sharing agreement. References to data sharing may also be appropriate in
other sections of the application.
Applicants requesting
more than $500,000 in direct costs in any year of the proposed research must
include a plan for sharing research data in their application. The funding
organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).
The reasonableness of the data sharing plan or the
rationale for not sharing research data may be assessed by the reviewers.
However, reviewers will not factor the proposed data sharing plan into the
determination of scientific merit or the priority score.
Sharing Research Resources
NIH policy requires that
grant awardee recipients make unique research resources readily available for
research purposes to qualified individuals within the scientific community
after publication (NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm
and http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131).
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of the resources sharing plan and any
related data sharing plans will be considered by Program staff of the funding
organization when making recommendations about funding applications. The
effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section
VI.3. Reporting.
Section
V. Application Review Information
1. Criteria
Only the review
criteria described below will be considered in the review process.
2. Review and Selection Process
Applications submitted
for this funding opportunity will be assigned to the ICs on the basis of
established PHS referral guidelines.
Appropriate scientific review groups convened in
accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm)
will evaluate applications for scientific and technical merit.
As part of the initial
merit review, all applications will:
Environment: Does the scientific
environment in which the work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative arrangements?
Is there evidence of institutional support?
2.A. Additional Review
Criteria:
In addition to the above
criteria, the following items will continue to 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 the Research Plan, Section E on Human Subjects in the PHS Form
398).
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 will be assessed. Plans for the recruitment and retention of subjects
will also be evaluated (see the Research Plan, Section E on Human Subjects in
the PHS Form 398).
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
Form 398 research grant application instructions will be assessed.
Biohazards: If materials or procedures
are proposed that are potentially hazardous to research personnel and/or the
environment, determine if the proposed protection is adequate.
2.B. Additional Review
Considerations
Budget: The reasonableness of the
proposed budget and the requested period of support in relation to the proposed
research. The priority score should not be affected by the evaluation of the
budget.
2.C. Sharing Research Data
Data Sharing Plan: The reasonableness of the
data sharing plan or the rationale for not sharing research data may be
assessed by the reviewers. However, reviewers will not factor the proposed data
sharing plan into the determination of scientific merit or the priority score.
The funding organization will be responsible for monitoring the data sharing
policy. http://grants.nih.gov/grants/policy/data_sharing.
2.D. Sharing Research
Resources
NIH
policy requires that grant awardee recipients make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication (See the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps/part_ii_5.htm#availofrr
and http://www.ott.nih.gov/policy/rt_guide_final.html).
Investigators responding to this funding opportunity should include a sharing
research resources plan addressing how unique research resources will be shared
or explain why sharing is not possible.
Program staff will be
responsible for the administrative review of the plan for sharing research
resources.
The adequacy of the
resources sharing plan will be considered by Program staff of the funding
organization when making recommendations about funding applications. Program
staff may negotiate modifications of the data and resource sharing plans with
the awardee before recommending funding of an application. The final version of
the data and resource sharing plans negotiated by both will become a condition
of the award of the grant. The effectiveness of the resource sharing will be
evaluated as part of the administrative review of each non-competing Grant
Progress Report (PHS 2590). See Section
VI.3. Reporting.
3. Anticipated Announcement and Award Dates
N/A
Section VI. Award Administration Information
1. Award Notices
After the
peer review of the application is completed, the PI will be able to access his
or her Summary Statement (written critique) via the NIH eRA Commons.
If the application is under consideration for funding,
NIH will request "just-in-time" information from the applicant. For
details, applicants may refer to the NIH Grants Policy Statement Part II: Terms
and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm).
A formal notification in the form of a Notice
of Award (NoA) will be provided to the applicant organization. The NoA
signed by the grants management officer is the authorizing document. Once all
administrative and programmatic issues have been resolved, the NoA will be
generated via email notification from the awarding component to the grantee
business official (designated in item 12 on the Application Face Page). If a
grantee is not email enabled, a hard copy of the NoA will be mailed to the
business official.
Selection of an application for award is not an
authorization to begin performance. Any costs incurred before receipt of the NoA
are at the recipient's risk. These costs may be reimbursed only to the extent
considered allowable pre-award costs. See Also Section
IV.5. Funding Restrictions.
2. Administrative and National
Policy Requirements
All NIH grant and
cooperative agreement awards include the NIH Grants Policy Statement as part of
the NoA. For these terms of award, see the NIH Grants Policy Statement Part II:
Terms and Conditions of NIH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part4.htm)
and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and
Conditions for Specific Types of Grants, Grantees, and Activities (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part9.htm).
3. Reporting
Awardees will be
required to submit the PHS Non-Competing Grant Progress Report, Form 2590
annually (http://grants.nih.gov/grants/funding/2590/2590.htm)
and financial statements as required in the NIH Grants Policy Statement.
We
encourage your inquiries concerning this funding opportunity 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:
1. Scientific/Research Contacts:
Dr. John W. Kusiak
Center for Integrative Biology and Infectious Diseases
National Institute of Dental and Craniofacial Research
National
Institutes of Health
Building # 45, Room 4AN-18A
45 Center Drive
Bethesda, MD 20892-6402
Telephone: (301) 594-7984
FAX: 301-480-8319
Email: kusiakj@mail.nih.gov
Dr. Lynn E. Luethke
Division
of Scientific Programs
National
Institute on Deafness and Other Communication Disorders
National
Institutes of Health
6120
Executive Blvd,
400-C
Bethesda, MD 20892-7180
Telephone:
(301) 402-3458
FAX: (301) 402-6251
Email: luethkel@nidcd.nih.gov
Dr. Linda L. Porter
Systems
and Cognitive Neuroscience
National
Institute of Neurological Disorders and Stroke
6001
Executive Blvd. Room 2113
Bethesda, MD 20892-9521
Telephone:
(301) 496-9964
FAX: (301) 402-2060
Email: lp216a@nih.gov
Dr. Bernadette Tyree
Cartilage
and Connective Tissue Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
6701
Democracy Blvd., Suite 800
Bethesda, MD 20892
Telephone:
(301) 594-5032
FAX: (301) 480-4543
Email: tyreeb@mail.nih.gov
Dr. Eleanor Hanna
Associate
Director for Special Projects and Centers
Office of
Research on Women’s Health
Office of
the Director
National
Institutes of Health
Building
1, Room 201
Bethesda, MD 20892
Telephone:
(301) 435-1753
FAX: (310) 402-0005
Email: hannae@od.nih.gov
2. Peer Review Contacts:
N/A
3. Financial or Grants Management Contacts:
National Institute of Dental
and Craniofacial Research
Mary Daley, Chief Grants Management Officer
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National
Institutes of Health
Building # 45, Room 4AN-44B
45 Center Drive
Bethesda, MD 20892-6402
Telephone: (301) 594-4808
FAX: 301- 480-3562
Email: daleym@mail.nih.gov
National
Institute on Deafness and Other Communication Disorders
Christopher Myers
Grants
Management Branch
Division
of Extramural Activities
NIDCD,
NIH
Executive Plaza South, Room 400B
6120
Executive Blvd., MSC 7180
Bethesda, MD 20892-7180
(20852
for express mail)
Telephone:
(301) 435-0713
FAX: (301) 402-1758
Email: myersc@mail.nih.gov
National
Institute of Neurological Disorders and Stroke
(Ken) King P. Bond, Jr.
Section
Chief/Grants Management Officer
Grants
Management Branch
National
Institute of Neurological Disorders and Stroke
Division
of Extramural Research
6001
Executive Blvd., Room 3256
Bethesda, MD 20892-9537
Tel: 301-496-3813
Fax: 301 451-5635
Email: kb33s@nih.gov
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Melinda Nelson
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Extramural
Program
Grants
Management Officer
6701
Democracy Blvd., Suite 800, MSC 4872
Bethesda, MD 20892-4872
Telephone:
(301) 594-3535
FAX: (301) 480-5450
Email: nelson1@mail.nih.gov
Section VIII. Other Information
Required Federal Citations
Use of Animals in
Research:
Recipients of PHS
support for activities involving live, vertebrate animals must comply with PHS
Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable.
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).
Data and Safety
Monitoring Plan:
Data and safety
monitoring is required for all types of clinical trials, including physiologic
toxicity and dose-finding studies (phase I); efficacy studies (Phase II);
efficacy, effectiveness and comparative trials (Phase III). Monitoring should
be commensurate with risk. The establishment of data and safety monitoring
boards (DSMBs) is required for multi-site clinical trials involving
interventions that entail potential risks to the participants (NIH Policy for
Data and Safety Monitoring, NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).
Sharing Research
Data:
Investigators submitting
an NIH application seeking $500,000 or more in direct costs in any single year
are expected to include a plan for data sharing or state why this is not possible
(http://grants.nih.gov/grants/policy/data_sharing).
Investigators should seek guidance from their
institutions, on issues related to institutional policies and local IRB rules,
as well as local, State and Federal laws and regulations, including the Privacy
Rule. Reviewers will consider the data sharing plan but will not factor the
plan into the determination of the scientific merit or the priority score.
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 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 funding opportunity 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.
Sharing of Model
Organisms:
NIH is committed to
support efforts that encourage sharing of important research resources
including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm).
At the same time the NIH recognizes the rights of grantees and contractors to
elect and retain title to subject inventions developed with Federal funding
pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/index.htm).
All investigators submitting an NIH application or contract proposal, beginning
with the October 1, 2004 receipt date, are expected to include in the
application/proposal a description of a specific plan for sharing and
distributing unique model organism research resources generated using NIH
funding or state why such sharing is restricted or not possible. This will
permit other researchers to benefit from the resources developed with public
funding. The inclusion of a model organism sharing plan is not subject to a
cost threshold in any year and is expected to be included in all applications
where the development of model organisms is anticipated.
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 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines is 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 Clinical Research:
The NIH maintains a
policy that children (i.e., individuals under the age of 21) must be included
in all clinical research, conducted or supported by the NIH, unless there are
scientific and ethical reasons not to include them.
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 (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 applications for research involving human subjects and individuals
designated as key personnel. The policy is available at http://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 http://stemcells.nih.gov/index.asp
and at http://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 (http://escr.nih.gov/). It is the responsibility
of the applicant to provide in the project description and elsewhere in the
application as appropriate, 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.
NIH Public Access
Policy:
NIH-funded investigators
are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed
Central (PMC) an electronic version of the author's final manuscript upon
acceptance for publication, resulting from research supported in whole or in
part with direct costs from NIH. The author's final manuscript is defined as
the final version accepted for journal publication, and includes all
modifications from the publishing peer review process.
NIH is requesting that
authors submit manuscripts resulting from 1) currently funded NIH research
projects or 2) previously supported NIH research projects if they are accepted
for publication on or after May 2, 2005. The NIH Public Access Policy applies
to all research grant and career development award mechanisms, cooperative
agreements, contracts, Institutional and Individual Ruth L. Kirschstein
National Research Service Awards, as well as NIH intramural research studies.
The Policy applies to peer-reviewed, original research publications that have
been supported in whole or in part with direct costs from NIH, but it does not
apply to book chapters, editorials, reviews, or conference proceedings.
Publications resulting from non-NIH-supported research projects should not be
submitted.
For more information
about the Policy or the submission process please visit the NIH Public Access
Policy Web site at http://publicaccess.nih.gov/ and
view the Policy or other Resources and Tools including the Authors' Manual (http://publicaccess.nih.gov/publicaccess_Manual.htm).
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).
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 PA 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 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.
Loan Repayment
Programs:
NIH encourages
applications for educational loan repayment from qualified health professionals
who have made a commitment to pursue a research career involving clinical,
pediatric, contraception, infertility, and health disparities related areas.
The LRP is an important component of NIH's efforts to recruit and retain the
next generation of researchers by providing the means for developing a research
career unfettered by the burden of student loan debt. Note that an NIH grant is
not required for eligibility and concurrent career award and LRP applications are
encouraged. The periods of career award and LRP award may overlap providing the
LRP recipient with the required commitment of time and effort, as LRP awardees
must commit at least 50% of their time (at least 20 hours per week based on a
40 hour week) for two years to the research. For further information, please
see: http://www.lrp.nih.gov/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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