RELEASE DATE:  June 25, 2004 

RFA Number:  RFA-ES-04-008 
EXPIRATION DATE:  September 15, 2004

Department of Health and Human Services (DHHS)

National Institutes of Health (NIH)

National Institute of Environmental Health Sciences (NIEHS) 
National Institute on Alcohol Abuse and Alcoholism (NIAAA) 

93.115 (NIEHS); 93.273 (NIAAA)  

APPLICATION RECEIPT DATE: September 14, 2004  


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 Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations


The National Institute of Environmental Health Sciences (NIEHS) and the 
National Institute of Alcohol Abuse and Alcoholism (NIAAA) invite 
research applications that use metabolomics technologies to study 
metabolic and regulatory pathways that are perturbed by environmental 
exposures and can lead to the development of toxicity and disease.  
The characterization of metabolic profiles in the context of molecular 
and biochemical changes resulting from environmental exposures provides 
an integrative approach to study more directly the relationships between 
exposure and disease. Ultimately, a metabolomic approach to studying 
biological systems should lead to (1) a better understanding of the 
mechanism(s) involved in the dysregulation of pathways by environmental 
agents, (2) the development of predictive biomarkers or surrogate 
endpoints of toxicity or clinical response and 3) a more rational 
approach for the development of disease intervention/prevention 
strategies. This initiative builds on and complements the 2003 NIH 
Roadmap Initiative in Metabolomics Technology Development which 
encourages the development of new technologies to identify and quantify 
cellular metabolites and their fluxes at high anatomical, spatial and 
temporal resolution. 



Metabolomics is an emerging field that involves the study of the 
metabolome, the complement of all metabolites expressed in a cell, 
tissue or organism during its lifetime. Metabolomics studies seek to 
define the levels, activities, regulation and interactions of all 
metabolites in a biological system and how these quantities or 
interactions change in response to external stimuli. Changes in the 
metabolome are directly influenced by environmental factors and genetic 
alterations. Consequently, metabolomics is an effective tool for 
studying the individual and combined effects of environmental and 
genetic factors on disease processes.

The advent of new metabolomics technologies has provided to the research 
community the ability to assess changes in metabolites and their levels 
on a broad scale, providing a global perspective about how an organism 
responds to a specific stressor. This information can be used to define 
cellular pathways and networks of response, identify target molecules of 
toxicity, provide biomarkers and surrogate endpoints of disease, and 
establish a functional basis for defining the contribution of genetic 
polymorphism to individual susceptibility to environmental exposures and 
disease. Thus, the application of metabolomics provides a new approach 
for defining gene-environment interactions in disease and for monitoring 
and modulating the disease process.

The importance of metabolomics research for environmental health 
sciences lies in linking metabolite changes with perturbations in the 
dynamic metabolic and regulatory processes that mediate cellular 
function, potentially leading to the development of new markers or 
surrogate endpoints of toxicity or clinical response. Understanding 
these changes could potentially lead to the development of new markers 
or surrogate endpoints of toxicity or clinical response. Because most 
environmentally related diseases are complex and multi-factorial, there 
are likely to be multiple markers or mechanistic endpoints that are 
intermediate between the exposure and the disease. Metabolomics offers a 
global approach to metabolite analysis that is appropriate for defining 
these markers for pathophysiological or clinical endpoints. 

Research Goals and Objectives

The primary goal of this solicitation is to encourage hypothesis-driven 
research that focus on the use of metabolomic technologies to study the 
dynamics of cellular pathways and their perturbation by environmental 
factors. The NIEHS is specifically interested in studies that address 
either exogenous factors such as chemical and physical stressors or 
endogenous (physiological) stressors. The NIAAA is interested in studies 
that focus on alcohol as the environmental stressor. This solicitation 
builds on and complements the NIH Roadmap initiative in Metabolomics 
Technology Development 
The Roadmap initiative encourages the development of highly innovative
and sensitive tools for characterizing cellular metabolites and their
fluxes at high anatomical, spatial, and temporal resolution. This RFA
should further advance the science of metabolomics by encouraging the
use of these tools to address research needs in environmental health science.

Examples of metabolomic research topics that may be proposed include, 
but are not limited to the following (not in order of priority):

o Studies that link quantitative global metabolic changes with 
cellular pathway perturbation and disease progression resulting from 
environmental stressors. 

o Studies that use metabolomic profiling to define genetic and 
metabolic factors that contribute to differential individual 
susceptibility to toxicity or disease resulting from exposure to 
environmental factors.

o Studies to assess changes in metabolite concentration, activity, or 
flux patterns in conjunction with biochemical functions at the tissue, 
organ or whole organism level that may be relevant to environmentally 
related disease or dysfunction (e.g., metabolic, neurological, renal, 
hepatic, cardiovascular, endocrine or reproductive function).

o Studies conducted in clinical populations or as adjunct to ongoing 
epidemiological studies to quantify global metabolic changes that can 
be plausibly correlated with biological mechanism and/or potentially 
serve as markers or surrogate endpoints for environmentally related 
disease or dysfunction. 

o Functional and comparative studies that use quantitative metabolomic 
approaches to examine perturbation of specific metabolic or regulatory 
pathways by environmental factors in more than one animal model. These 
comparisons will allow us to elucidate pathways, networks and molecular 
cascades that are conserved and are of critical importance in normal and 
compensatory biological responses to environmental stressors.

In vivo and in vitro experimental models are appropriate and include 
whole animal, organ or tissue culture systems. Animal models including 
naturally susceptible or genetically or pharmacologically manipulated 
models are acceptable. Human biological samples (e.g., blood or urine) 
that are derived from new or ongoing clinical investigations or 
epidemiological studies are specifically encouraged as a means of 
identifying metabolite changes that can be correlated with human 
disease progression and of establishing biomarkers and surrogate 
endpoints in translational and clinical settings.  

The proposed metabolomics approaches may be derived from existing 
technologies, such as NMR and mass spectroscopy, or involve new 
approaches for measuring cellular metabolomes or subsets (e.g., 
peptides, lipids). Applications that propose only to survey and 
catalog metabolite expression patterns in response to exposure to 
environmental agents will be considered non-responsive to this RFA. 
Rather, applications should focus on using metabolomics approaches to 
enhance our understanding of a particular environmentally responsive 
pathway by defining metabolite changes or markers that can be 
correlated with perturbation or disease progression.


This RFA will use the National Institutes of Health (NIH) research 
project grant (R01) award mechanism. The R01 grant mechanism supports a 
discrete, specified, circumscribed research project that is well-
grounded on current knowledge and is to be performed by the named 
investigator(s) in an area of research representing his/her/their 
specific interest and competencies. 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 be reviewed according to the 
customary peer review procedures. The anticipated award date is July 
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. It also uses the modular as well as 
the non-modular budgeting formats (see Specifically, if you 
are submitting an application with direct costs in each year of $250,000 
or less, use the modular budget format. Otherwise follow the 
instructions for non-modular research grant applications. This program 
does not require cost sharing as defined in the current NIH Grants 
Policy Statement at


The NIEHS intends to commit approximately $3.75 million in FY 2005 to 
fund six to ten new grants in response to this RFA. The NIAAA intends to 
commit up to $350,000 to fund one new grant specifically related to 
alcohol effects. An applicant may request a project period of up to five 
years and a budget for direct costs of up to $350,000 per year. Should 
an applicant plan to include subcontracts to other institutions or 
organizations, only the direct costs associated with the subcontracts 
will be used to tally the direct costs that apply toward the cap. 

Because the nature and scope of research proposed might vary, it is 
anticipated that the size of each award will also vary. Although the 
financial plans of the NIEHS and the NIAAA 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. At this time, it is not known if this RFA will 
be reissued.


You may submit (an) application(s) if your institution has any of the 
following characteristics:

o Domestic or foreign non-profit organizations. Applications will not be 
accepted from for-profit organizations; however, applicant organizations 
may establish subcontract arrangements with for-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 Faith-based or community-based organizations.


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.


Applicants should request funds for one trip/year for an annual meeting 
of grantees to be held at NIEHS in Research Triangle Park, North 
Carolina. The purpose for these meetings is to discuss scientific 
advances and to discuss the potential for collaborations, data sharing, 
data repositories and other research opportunities.

The policy of the PHS is to make available to the public results and 
accomplishments of activities that it funds. All awardees must adhere to 
PHS policy for distribution of unique research resources produced with 
PHS funding, which was published at
Public databases are being developed at NIEHS for the submission of 
genomics, proteomics and metabolomics data. Applicants may be requested 
to submit findings to these databases.


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:

Brenda K. Weis, Ph.D.
Scientific Program Administrator
Center for Risk and Integrated Sciences
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-23
79 T.W. Alexander Drive, Building 4401
Research Triangle Park, NC  27709
Telephone: (919) 541-4964
FAX: (919) 316-4937

Lorraine Gunzerath, Ph.D., MBA
Health Scientist Administrator 
Office of Scientific Affairs 
National Institute on Alcohol Abuse and Alcoholism 
Willco Building, Suite 409 
6000 Executive Boulevard 
Bethesda, MD 20892-7003 
Telephone: (301) 443-2369  
Fax: (301) 443-6077  

o Direct your questions about peer review issues to:

Teresa Nesbitt, D.V.M., Ph.D.
Chief, Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-20
Research Triangle Park, NC 27709
Telephone: (919) 541-7571 
Fax: (919) 541-2503 

o Direct your questions about financial or grants management matters to:

Ms. Lisa Archer
Grants Management Specialist
Grants Management Branch
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-22
79 T.W. Alexander Drive, Building 4401
Research Triangle Park, NC  27709
Telephone: (919) 541-0751
FAX: (919) 541-2860


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 staff at NIEHS and NIAAA 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:

Teresa Nesbitt, D.V.M., Ph.D.
Chief, Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-20
Research Triangle Park, NC 27709
Telephone: (919) 541-7571
Fax: (919) 541-2503 


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 
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 in an 
interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 710-0267, Email:

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
includes step-by-step guidance for preparing modular grants. Additional 
information on modular grants is available at

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:

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:

Teresa Nesbitt, D.V.M., Ph.D.
Chief, Scientific Review Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233, MD EC-20
Research Triangle Park, NC 27709
Telephone: (919) 541-7571 
Fax: (919) 541-2503 

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 previous 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 


Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by the NIEHS and NIAAA. 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 NIEHS 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 respective NIEHS and NIAAA 
advisory councils. 


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 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 have to be strong in all categories to be 
judged likely to have a 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 
method? 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 

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:

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).

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).

are to be used in the project, the five items described under Section f 
of the PHH research grant application instructions (rev. 5/2001) will be 


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

Letter of Intent Receipt Date: August 13, 2004
Application Receipt Date: September 14, 2004
Peer Review Date: February 2005
Council Review: May 2005
Earliest Anticipated Start Date: July 2005


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


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 

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). The establishment of 
data and safety monitoring boards (DSMBs) is required for multi-site 
clinical trials involving interventions that entail potential risk to 
the participants. (NIH Policy for Data and Safety Monitoring, NIH 
Guide for Grants and Contracts, June 12, 1998:

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 
a complete copy of the updated Guidelines are available at
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.

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. 

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

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

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on hESCs can be found at
and at
Only research using hESC lines that are registered in the NIH 
Human Embryonic Stem Cell Registry will be eligible for Federal funding 
(see 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. 

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:

Applicants may wish to place data collected under this RFA in a public 
archive, which can provide protections for the data and manage the 
distribution for an indefinite period of time. If so, the application 
should include a description of the archiving plan in the study design 
and include information about this in the budget justification section 
of the application. In addition, applicants should think about how to 
structure informed consent statements and other human subjects 
procedures given the potential for wider use of data collected under 
this award.

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 (HIPPA) 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 
( 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 HIPPA Privacy Rule 
on NIH processes involving the review, funding, and progress monitoring 
of grants, cooperative agreements, and research contracts can be found 

proposals for NIH funding must be self-contained within specified page 
limitations. Unless otherwise specified in an NIH solicitation, Internet 
addresses (URLs) should not be used to provide information necessary to 
the review because reviewers are under no obligation to view the 
Internet sites. Reviewers are cautioned that their anonymity may be 
compromised when they directly access an Internet site.

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

AUTHORITY AND REGULATIONS: This program is described in the Catalog of 
Federal Domestic Assistance at 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 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

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

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NIH Funding Opportunities and Notices

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