MECHANISMS OF OROFACIAL PAIN: ANATOMY, GENOMICS AND PROTEOMICS
RELEASE DATE: November 19, 2003
RFA Number: RFA-DE-05-004
Department of Health and Human Services (DHHS)
PARTICIPATING ORGANIZATION:
National Institutes of Health (NIH)
(http://www.nih.gov)
COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute of Dental and Craniofacial Research (NIDCR)
(http://www.nidr.nih.gov)
National Institute of Neurological Disorders and Stroke (NINDS)
(http://www.ninds.nih.gov)
CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S) 93.121 (NIDCR) 93.853
(NINDS)
LETTER OF INTENT RECEIPT DATE: April 19, 2004
APPLICATION RECEIPT DATE: May 14, 2004
THIS RFA CONTAINS THE FOLLOWING INFORMATION
o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations
PURPOSE OF THIS RFA
The National Institute of Dental and Craniofacial Research (NIDCR),
along with the National Institute of Neurological Disorders and Stroke
(NINDS), invites applications to stimulate and support innovative,
interdisciplinary research studies to elucidate the molecular
mechanisms underlying orofacial pain, particularly the discovery of
proteins and protein networks critical to processing nociceptive
information.
The purpose of this RFA is to encourage the use of genomic and
proteomic approaches and imaging techniques to clarify the molecular
events involved in: 1) acute orofacial pain, 2) the transition from
unrelieved acute pain to chronic pain (i.e. neuroplasticity), 3)
neuronal hyperexcitability as manifested by hyperalgesia and allodynia,
and 4) chronic orofacial pain disorders of an inflammatory and
neuropathic origin. This improved understanding could lead to new
therapeutic interventions to effectively treat chronic pain conditions.
Collaborative projects involving interdisciplinary teams of
investigators are strongly encouraged. This Request for Applications
contributes to the goals of the NIH Pain Consortium, which is co-
chaired by NIDCR, NINDS, and the National Institute of Nursing Research
(NINR).
RESEARCH OBJECTIVES
Background
Chronic pain affects a large percentage of the population with an
annual cost of about $100 billion. Orofacial pain is reported by more
than 20% of the population and is one of the most common reasons for
visits to a physician. Inappropriate treatment of acute pain can lead
to chronic pain. Compounding the problem is the fact that chronic pain
is not well treated with current therapeutics. Opiates are the drugs of
choice for chronic pain but have negative aspects of tolerance and
other, potentially dangerous, side effects and are not always
completely successful in alleviating the pain. Thus, in order to
effectively treat chronic pain conditions a better understanding of the
underlying etiology and molecular pathogenesis of these conditions is
needed. Through this approach, key molecules will be identified that
could serve as new therapeutic targets.
A noxious stimulus causes acute pain and responses to this stimulus are
protective reactions. Normally, once the noxious stimulus is removed,
pain disappears. However, in some instances, for example if there is
tissue damage, the acute pain persists in the absence of noxious
stimuli. This chronic pain may be due to persistent tissue inflammatory
responses, damage to the nervous system (neuropathic pain), or
unrelieved acute pain. Neuropathic pain is associated with neuronal
hyperexcitability in damaged areas, spinal cord, and brain and leads to
heightened responses to stressful stimuli. It is clear that neuronal
plasticity plays a role in chronic pain, but the triggers that initiate
this process and the changes that occur in the peripheral and central
nervous systems have not been clearly identified. However, they may
include changes in gene expression, redistribution of key membrane
receptors or ion channels, changes in neuronal phenotype, alterations
in synaptic connectivity, recruitment of silent nociceptors, and loss
of fibers.
A number of orofacial disorders such as temporomandibular joint
disorders (TMJD), dental pain and trigeminal neuralgia are associated
with chronic pain. The pathophysiology of these disorders is poorly
understood. Thus, there is a need to examine the pain experience at
all levels of basic and clinical research. This will entail delineation
of peripheral nervous system and central nervous system circuitry
involved in the detection of noxious stimuli and the modulation of pain
signals, identification of the brain areas responsible for processing
and integrating this information, discovery of key proteins involved in
transmission of nociceptive stimuli from the periphery to the brain,
and assembly of an integrated picture of pain processes. Ion channels,
ligand-gated ion channels, neurotrophic factors and their receptors,
transcription factors, serine/threonine and tyrosine kinases, and cell
adhesion molecules are examples of gene families thought to play
important roles in responses to noxious stimuli. Peripheral nociceptor
fields, spinal and brainstem relay points, and cerebral cortex are
anatomical areas of major interest in pain pathways and are locations
where modulation of synaptic activity may alter the pain response.
Identifying proteins whose levels of expression, post-translational
modification, and subcellular distribution are altered in chronic pain
disorders will be important in elucidating nervous system plasticity in
response to noxious stimuli.
Neuroimaging approaches are important in delineating specific brain
regions that process pain signals. Examination of these active areas
with genomic and proteomic approaches will help to identify changes in
protein expression that may be important in pain sensation. Functional
imaging may identify changes in neurotransmitter receptor activity,
which, in turn, can elucidate signaling pathways active in processing
pain signals.
Computer analyses can be performed to establish the existence of
integrated genetic networks of expressed genes related to pain and
inflammatory processes. By comparing molecular profiles in chronic
orofacial pain and in control samples, additional targets for potential
therapeutic intervention may be identified.
Research Objectives and Scope
The objective of this RFA is to encourage the use of genomic and
proteomic approaches for the identification of molecular mechanisms
involved in orofacial pain disorders in order to gain a better
understanding of the pathophysiology of these disorders. Such
experimental approaches will reveal the molecular networks that
regulate orofacial pain and clarify the pathogenic mechanisms leading
to orofacial pain disorders. In addition, these investigations coupled
with molecular imaging and biocomputational technologies will provide a
basis for gene-based diagnostic criteria and insights for developing
novel prevention and therapeutic strategies that are case and patient
specific. To accomplish the goals of this solicitation, the
establishment of interdisciplinary teams of investigators with
expertise in biology, genomics, proteomics, and imaging as well as in
clinical and computational sciences is encouraged.
The following are some examples of research topics relevant to this RFA
but not limited to .
o Elucidation of genes, proteins, and protein modifications involved in
the transition from acute to chronic pain using genomic and proteomic
approaches;
o Examination of the changes in gene and protein expression in
trigeminal ganglion, spinal cord, brain stem, and cortex in chronic
pain states;
o Characterization of changes in protein expression in the neuronal
hyperexcitatory state found in chronic pain and the process involved in
the induction of hyperexcitability at peripheral nociceptors, spinal
cord, ascending pain tracts and in the brain;
o Identification of functional protein networks involved in transducing
noxious stimuli into pain signals both peripherally and centrally;
o Elucidation of the roles of central (including descending modulation)
and peripheral (including effector function of afferent fibers)
neuronal plasticity in mediating the onset of chronic pain in
craniofacial regions;
o Determination of the differences in the molecular mechanisms leading
to chronic pain caused by inflammatory or neuropathic injury;
o Establishment of new model systems that better mimic clinical
features of orofacial pain disorders, including those in which deep
tissue pain is involved;
o Identification of cortical brain areas important in orofacial pain
processing through the use of neuroimaging;
o Elucidation of the role of estrogen (genomic and non-genomic effects)
in the pathophysiology of pain including the influence of estrogen on
neurotrophic growth factor expression;
o Investigations of orofacial pain using patient material (cell lines,
DNA from patient cohorts, etc.) for gene discovery, linkage and
candidate gene analyses, and SNP analysis.
Applicants are encouraged to obtain biological samples from the NIDCR
TMJ Implant Registry and Repository (http://Tmjregistry.org). Prior to
requesting samples, applicants should contact Dr. James Fricton
[frict001@umn.edu] at the University of Minnesota School of Dentistry,
Minneapolis, Minnesota.
MECHANISM OF SUPPORT
This RFA will use the NIH R01 award mechanism(s). As an applicant you
will be solely responsible for planning, directing, and executing the
proposed project. This RFA is a one-time solicitation. Future
unsolicited, competing-continuation applications based on this project
will compete with all investigator-initiated applications and will be
reviewed according to the customary peer review procedures. The
anticipated award date is April 2005. Applications that are not funded
in the competition described in this RFA may be resubmitted as NEW
investigator-initiated applications using the standard receipt dates
for NEW applications described in the instructions to the PHS 398
application.
This RFA uses just-in-time concepts and the modular budgeting formats
(see http://grants.nih.gov/grants/funding/modular/modular.htm). This
program does not require cost sharing as defined in the current NIH
Grants Policy Statement at
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.
FUNDS AVAILABLE
The NIDCR intends to commit approximately $3.0 million in FY 05 or FY
06 to fund 8 to 10 new grants in response to this RFA. The NINDS
intends to commit $700,000 in FY 05 to fund approximately 2 new grants
in response to this RFA. The NINDS is especially interested in
meritorious applications that are relevant to its mission, including
those that relate to neuropathic pain and neurogenic inflammatory pain
of craniofacial structures. An applicant may request a project period
of up to 5 years and a budget for direct costs of up to $250,000 per
year. Because the nature and scope of the proposed research will vary
from application to application, it is anticipated that the size and
duration of each award will also vary. Although the financial plans of
the ICs provide support for this program, awards pursuant to this RFA
are contingent upon the availability of funds and the receipt of a
sufficient number of meritorious applications.
ELIGIBLE INSTITUTIONS
You may submit (an) application(s) if your institution has any of the
following characteristics:
o For-profit or non-profit organizations
o Public or private institutions, such as universities, colleges,
hospitals, and laboratories
o Units of State and local governments
o Eligible agencies of the Federal government
o Domestic or foreign institutions/organizations
o Faith-based or community-based organizations
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
Any individual with the skills, knowledge, and resources necessary to
carry out the proposed research is invited to work with their
institution to develop an application for support. Individuals from
underrepresented racial and ethnic groups as well as individuals with
disabilities are always encouraged to apply for NIH programs.
SPECIAL REQUIREMENTS
To the extent possible, applicants should make data from these studies
(including gene sets, protein sets, brain images, etc.) available in a
form and in a manner that expedites their usefulness to a wide range of
researchers. NIH believes that data sharing is essential for expedited
translation of research results into knowledge, products, and
procedures to improve human health. The NIH endorses the sharing of
final research data to serve these and other important scientific
goals. The NIH expects and supports the timely release and sharing of
final research data from NIH-supported studies for use by other
researchers. NIH recognizes that data sharing may be complicated or
limited, in some cases, by institutional policies, local IRB rules, as
well as local, state and Federal laws and regulations, including the
Privacy Rule (available at http://www.hhs.gov/ocr/). The Privacy Rule
is a federal regulation that governs how certain health care providers,
health care clearinghouses, and health plans, known as "covered
entities," use and disclose identifiable health information. As NIH
stated in the March 1, 2002 draft data sharing statement
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-035.html),
the rights and privacy of people who participate in NIH-sponsored
research must be protected at all times. Thus, data intended for
broader use should be free of identifiers that would permit linkages to
individual research participants and variables that could lead to
deductive disclosure of the identity of individual subjects.
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:
John W. Kusiak, Ph.D.
Director
Molecular and Cellular Neurobiology Program
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
National Institutes of Health
45 Center Drive, Building 45, Room 4AN-18A
Bethesda, MD 20892-6402
Telephone: 301-594-7984
FAX: 301-480-8319
Email: kusiakj@mail.nih.gov
Linda L. Porter, Ph.D.
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
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, Building 45, Room 4AN-44F
Bethesda, MD 20892-6402
Telephone: 301-594-2904
FAX: 301-480-8303
Email: hauschg@mail.nih.gov
o Direct your questions about financial or grants management matters
to:
Mary Daley
Chief Grants Management Officer
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
45 Center Drive, Building 45, Room 4AN-44B
Bethesda, MD 20892-6402
Telephone: 301-594-4808
FAX: 301-480-3562
Email: daleym@mail.nih.gov
LETTER OF INTENT
Prospective applicants are asked to submit a letter of intent that
includes the following information:
o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA
Although a letter of intent is not required, is not binding, and does
not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review
workload and plan the review.
The letter of intent is to be sent by the date listed at the beginning
of this document. The letter of intent should be sent to:
John W. Kusiak, Ph.D.
Director
Molecular and Cellular Neurobiology Program
Division of Basic and Translational Sciences
National Institute of Dental and Craniofacial Research
National Institutes of Health
45 Center Drive, Building 45, Room 4AN-18A
Bethesda, MD 20892-6402
Telephone: 301-594-7984
FAX: 301-480-8319
Email: kusiakj@mail.nih.gov
SUBMITTING AN APPLICATION
Applications must be prepared using the PHS 398 research grant
application instructions and forms (rev. 5/2001). Applications must
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS)
number as the Universal Identifier when applying for Federal grants or
cooperative agreements. The DUNS number can be obtained by calling
(866) 705-5711 or through the web site at
http://www.dunandbradstreet.com/. The DUNS number should be entered on
line 11 of the face page of the PHS 398 form. The PHS 398 document is
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in
an interactive format. For further assistance contact GrantsInfo,
Telephone (301) 710-0267, Email: GrantsInfo@nih.gov.
SUPPLEMENTARY INSTRUCTIONS
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications
requesting up to $250,000 per year in direct costs must be submitted in
a modular grant format. The modular grant format simplifies the
preparation of the budget in these applications by limiting the level
of budgetary detail. Applicants request direct costs in $25,000
modules. Section C of the research grant application instructions for
the PHS 398 (rev. 5/2001) at
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants. Additional information
on modular grants is available at
http://grants.nih.gov/grants/funding/modular/modular.htm.
USING THE RFA LABEL: The RFA label available in the PHS 398 (rev.
5/2001) application form must be affixed to the bottom of the face page
of the application. Type the RFA number on the label. Failure to use
this label could result in delayed processing of the application such
that it may not reach the review committee in time for review. In
addition, the RFA title and number must be typed on line 2 of the face
page of the application form and the YES box must be marked. The RFA
label is also available at:
http://grants.nih.gov/grants/funding/phs398/labels.pdf.
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten
original of the application, including the Checklist, and three signed,
photocopies, in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710
Bethesda, MD 20817 (for express/courier service)
At the time of submission, two additional copies of the application and
all copies of the appendix material must be sent to:
H. George Hausch, Ph.D
Acting Director
Division of Extramural Activities
National Institute of Dental and Craniofacial Research
National Institutes of Health
45 Center Drive, Building 45, Room 4AN-44F
Bethesda, MD 20892-6402
APPLICATION PROCESSING: Applications must be received on or before the
application receipt date listed in the heading of this RFA. If an
application is received after that date, it will be returned to the
applicant without review.
Although there is no immediate acknowledgement of the receipt of an
application, applicants are generally notified of the review and
funding assignment within 8 weeks.
The Center for Scientific Review (CSR) will not accept any application
in response to this RFA that is essentially the same as one currently
pending initial review, unless the applicant withdraws the pending
application. However, when a previously unfunded application,
originally submitted as an investigator-initiated application, is to be
submitted in response to an RFA, it is to be prepared as a NEW
application. That is, the application for the RFA must not include an
Introduction describing the changes and improvements made, and the text
must not be marked to indicate the changes from the previous unfunded
version of the application.
PEER REVIEW PROCESS
Upon receipt, applications will be reviewed for completeness by the CSR
and responsiveness by the NIDCR. Incomplete and/or nonresponsive
applications will not be reviewed.
Applications that are complete and responsive to the RFA will be
evaluated for scientific and technical merit by an appropriate peer
review group convened by the NIDCR in accordance with the review
criteria stated below. As part of the initial merit review, all
applications will:
o Undergo a process in which only those applications deemed to have the
highest scientific merit, generally the top half of the applications
under review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by the NIDCR National Advisory Council
or Board.
REVIEW CRITERIA
The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.
In the written comments, reviewers will be asked to evaluate the
application in order to judge the likelihood that the proposed research
will have a substantial impact on the pursuit of these goals. The
scientific review group will address and consider each of the following
criteria in assigning the application’s overall score, weighting them
as appropriate for each application.
o Significance
o Approach
o Innovation
o Investigator
o Environment
The application does not need to be strong in all categories to be
judged likely to have major scientific impact and thus deserve a high
priority score. For example, an investigator may propose to carry out
important work that by its nature is not innovative but is essential to
move a field forward.
SIGNIFICANCE: Does this study address an important problem? If the aims
of the application are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts or
methods that drive this field?
APPROACH: Are the conceptual framework, design, methods, and analyses
adequately developed, well-integrated, and appropriate to the aims of
the project? Does the applicant acknowledge potential problem areas and
consider alternative tactics?
INNOVATION: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
INVESTIGATOR: Is the investigator appropriately trained and well suited
to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)?
ENVIRONMENT: Does the scientific environment in which the 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, the
following items will be considered in the determination of scientific
merit and the priority score:
PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of
human subjects and protections from research risk relating to their
participation in the proposed research will be assessed. (See criteria
included in the section on Federal Citations, below).
INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: The adequacy
of plans to include subjects from both genders, all racial and ethnic
groups (and subgroups), and children as appropriate for the scientific
goals of the research. Plans for the recruitment and retention of
subjects will also be evaluated. (See Inclusion Criteria in the
sections on Federal Citations, below).
CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals
are to be used in the project, the five items described under Section f
of the PHS 398 research grant application instructions (rev. 5/2001)
will be assessed.
ADDITIONAL REVIEW CONSIDERATIONS
SHARING RESEARCH DATA: Applicants requesting more than $500,000 in
direct costs in any year of the proposed research must include a data
sharing plan in their application. The reasonableness of the data
sharing plan or the rationale for not sharing research data will be
assessed by the reviewers. However, reviewers will not factor the
proposed data sharing plan into the determination of scientific merit
or priority score.
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: April 19, 2004
Application Receipt Date: May 14, 2004
Peer Review Date: October 2004
Council Review: January 2005
Earliest Anticipated Start Date: April 2005
AWARD CRITERIA
Award criteria that will be used to make award decisions include:
o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities.
REQUIRED FEDERAL CITATIONS
HUMAN SUBJECTS PROTECTION: Federal regulations (45CFR46) require that
applications and proposals involving human subjects must be evaluated
with reference to the risks to the subjects, the adequacy of protection
against these risks, the potential benefits of the research to the
subjects and others, and the importance of the knowledge gained or to
be gained.
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date,
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, 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.
INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH: It is the policy
of the NIH that women and members of minority groups and their sub-
populations must be included in all NIH-supported clinical research
projects unless a clear and compelling justification is provided
indicating that inclusion is inappropriate with respect to the health of
the subjects or the purpose of the research. This policy results from
the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43).
All investigators proposing clinical research should read the "NIH
Guidelines for Inclusion of Women and Minorities as Subjects in
Clinical Research - Amended, October, 2001," published in the NIH Guide
for Grants and Contracts on October 9, 2001
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html);
a complete copy of the updated Guidelines are available at
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates: the use of an NIH definition
of clinical research; updated racial and ethnic categories in
compliance with the new OMB standards; clarification of language
governing NIH-defined Phase III clinical trials consistent with the new
PHS Form 398; and updated roles and responsibilities of NIH staff and
the extramural community. The policy continues to require for all NIH-
defined Phase III clinical trials that: a) all applications or
proposals and/or protocols must provide a description of plans to
conduct analyses, as appropriate, to address differences by sex/gender
and/or racial/ethnic groups, including subgroups if applicable; and b)
investigators must report annual accrual and progress in conducting
analyses, as appropriate, by sex/gender and/or racial/ethnic group
differences.
INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN
SUBJECTS: The NIH maintains a policy that children (i.e., individuals
under the age of 21) must be included in all human subjects research,
conducted or supported by the NIH, unless there are scientific and
ethical reasons not to include them. This policy applies to all initial
(Type 1) applications submitted for receipt dates after October 1,
1998.
All investigators proposing research involving human subjects should
read the "NIH Policy and Guidelines" on the inclusion of children as
participants in research involving human subjects that is available at
http://grants.nih.gov/grants/funding/children/children.htm
REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH
policy requires education on the protection of human subject
participants for all investigators submitting NIH proposals for
research involving human subjects. You will find this policy
announcement in the NIH Guide for Grants and Contracts Announcement,
dated June 5, 2000, at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.
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 (see
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.
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 PA in a public
archive, which can provide protections for the data and manage the
distribution for an indefinite period of time. If so, the application
should include a description of the archiving plan in the study design
and include information about this in the budget justification section
of the application. In addition, applicants should think about how to
structure informed consent statements and other human subjects
procedures given the potential for wider use of data collected under
this award.
STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:
The Department of Health and Human Services (DHHS) issued final
modification to the Standards for Privacy of Individually Identifiable
Health Information , the Privacy Rule, on August 14, 2002. The
Privacy Rule is a federal regulation under the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 that governs the
protection of individually identifiable health information, and is
administered and enforced by the DHHS Office for Civil Rights (OCR).
Those who must comply with the Privacy Rule (classified under the Rule
as covered entities ) must do so by April 14, 2003 (with the exception
of small health plans which have an extra year to comply).
Decisions about applicability and implementation of the Privacy Rule
reside with the researcher and his/her institution. The OCR website
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule,
including a complete Regulation Text and a set of decision tools on Am
I a covered entity? Information on the impact of the HIPAA Privacy
Rule on NIH processes involving the review, funding, and progress
monitoring of grants, cooperative agreements, and research contracts
can be found at
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.
URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and
proposals for NIH funding must be self-contained within specified page
limitations. Unless otherwise specified in an NIH solicitation, Internet
addresses (URLs) should not be used to provide information necessary to
the review because reviewers are under no obligation to view the
Internet sites. Furthermore, we caution reviewers that their anonymity
may be compromised when they directly access an Internet site.
HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting priority
areas. This RFA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at
http://www.healthypeople.gov/.
AUTHORITY AND REGULATIONS: This program is described in the Catalog of
Federal Domestic Assistance at http://www.cfda.gov/ and is not subject
to the intergovernmental review requirements of Executive Order 12372
or Health Systems Agency review. Awards are made under the
authorization of Sections 301 and 405 of the Public Health Service Act
as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52
and 45 CFR Parts 74 and 92. All awards are subject to the terms and
conditions, cost principles, and other considerations described in the
NIH Grants Policy Statement. The NIH Grants Policy Statement can be
found at http://grants.nih.gov/grants/policy/policy.htm
The PHS strongly encourages all grant recipients to provide a smoke-
free workplace and discourage the use of all tobacco products. In
addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits
smoking in certain facilities (or in some cases, any portion of a
facility) in which regular or routine education, library, day care,
health care, or early childhood development services are provided to
children. This is consistent with the PHS mission to protect and
advance the physical and mental health of the American people.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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Department of Health and Human Services (HHS)
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NIH... Turning Discovery Into Health®
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