Release Date:  May 25, 1999

RFA: HD-99-002

National Institute of Child Health and Human Development
National Institute of Dental and Craniofacial Research
National Institute of Environmental Health Sciences
Environmental Protection Agency

Letter of Intent Receipt Date:  July 1, 1999
Application Receipt Date:  August 20, 1999


The National Institute of Child Health and Human Development (NICHD), the
National Institute of Dental and Craniofacial Research (NIDCR) and the
National Institute of Environmental Health Sciences (NIEHS) of the National
Institutes of Health (NIH) and the Environmental Protection Agency (EPA)
invite research grant applications to study the genetic susceptibility and
mechanisms of human congenital malformations including research on the
contribution of potential genetic and environmental factors, identified at the
molecular level, to the etiology, distribution and prevention of disease
within families and across populations.  The research conducted as a result of
this RFA will provide the direction and focus for future initiatives to
dissect the molecular and genetic mechanisms underlying specific human
malformations.  The current initiative is designed to encourage collaborative,
interdisciplinary, and innovative studies that integrate the latest advances
in developmental genetics, functional genomics, epidemiology and high
throughput biotechnology with the new mathematical, methodological, and
statistical tools for analyzing and evaluating data related to the etiology
and distribution of birth defects in populations.  Applications limited to
descriptive or traditional epidemiological approaches will be considered non-
responsive.  The primary objective of this initiative is to develop and use
integrated multidisciplinary approaches to obtain information that will
enhance our knowledge of and provide a basis for future initiatives focusing
on the basic mechanisms and etiologies of human malformations.  This RFA is
part of a larger birth defects program which will include an upcoming
initiative related to fundamental developmental mechanisms underlying the
formation of structural anomalies.


The Public Health Service (PHS) is committed to achieving the health promotion
and disease prevention objectives of "Healthy People 2000," a PHS-led national
activity for setting priority areas.  This Request for Applications (RFA),
Genetic Susceptibility and Variability of Human Congenital Malformations, is
related to many priority areas.  Potential applicants may obtain a copy of
"Healthy People 2000" at


Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges,
hospitals, laboratories, units of State and local governments, and eligible
agencies of the Federal government. (Note: The EPA will not be able to
consider applications from for-profit organizations or Federal agencies.) 
Racial/ethnic minority individuals, women, and persons with disabilities are
encouraged to apply as Principal Investigators.


This RFA will use the National Institutes of Health (NIH) individual research
project grant (R01) award mechanism or the comparable EPA mechanism. 
Following peer review, applications selected for funding by the EPA will
require additional certifications and responses to comments or suggestions
offered by the peer reviewers.  The EPA will contact Principal Investigators
to obtain these materials.

Responsibility for the planning, direction, and execution of the proposed
project will be solely that of the applicant.  The total project period for
applications submitted in response to the present RFA may not exceed five
years.  The anticipated award date is March 1, 2000.

This RFA is a one-time solicitation.  Future unsolicited new or competing
continuation applications will compete with all investigator-initiated
applications and be referred and reviewed according to the customary peer
review procedures by the Center for Scientific Review (CSR).


It is anticipated that for Fiscal Year 2000, approximately $6.6 million
(including direct and Facilities and Administrative costs) in total costs will
be available for funding the first year of this initiative.  Since the nature
and scope of the proposed research may vary, it is anticipated that the size
of the awards will vary as well.  An applicant may request a project period of
up to five years and a budget for direct costs of up to $700,000 per year. 
Applications requesting direct costs of more than $700,000 in any one year
will be considered non-responsive.  Facilities and Administrative costs will
be awarded based on the negotiated rates.  Although this program is provided
for in the financial plans of the NICHD, NIDCR, NIEHS, and EPA, awards
pursuant to this RFA are contingent upon the availability of funds and the
receipt of a sufficient number of applications of outstanding scientific and
technical merit.  It is anticipated that approximately six awards will be



In the United States, birth defects are the leading cause of infant mortality,
accounting for one in five infant deaths.  It is estimated that more than
120,000 babies in the United States (about four percent of all live births)
are born with major birth defects each year.  Birth defects are involved in
about half of all pediatric hospital admissions and, next to accidents, are
the leading cause of death in children.  Moreover, the estimated lifetime cost
of children born each year with any of 17 major birth defects or cerebral
palsy to the U.S. economy is more than $8 billion.

In order to address the impact of birth defects on public health, the Center
for Research for Mothers and Children (CRMC), National Institute of Child
Health and Human Development (NICHD), convened a workshop in October 1997. 
The purpose of the workshop was to review the status of clinical and
epidemiological research on structural birth defects and to recommend and
prioritize areas of future research.  Genetic epidemiology of human
malformations was identified as a high priority area for future research. 
This new field of research has recently emerged from the integration of
genetics into traditional epidemiological research and focuses on the
contribution of genetic and environmental factors, identified at the molecular
level, to the etiology, distribution and prevention of disease within families
and across populations.  This RFA is designed to address that recommendation,
namely, to encourage and support collaborative and interdisciplinary studies
on human malformations that integrate the latest advances in developmental and
molecular genetics with the new and innovative mathematical, methodological,
and statistical developments for analyzing and evaluating epidemiological
data.  The outcome of these studies will lay the foundation for the
development of future initiatives that will focus on the molecular genetics
and developmental biology of structural birth defects.

A second workshop was held on 20-21 July, 1998, with the agenda of
prioritizing national needs that the NICHD should address in formulating a
comprehensive strategy for birth defects research.  This conference and an
upcoming initiative focus on the molecular genetics and basic developmental
mechanisms associated with the formation of congenital anomalies.  The NICHD
sees these two approaches as necessary in enhancing our understanding of and,
ultimately, devising prevention strategies for structural birth defects.

The National Institute of Environmental Health Sciences (NIEHS) is the
principal Federal funding agency that supports research focused on
understanding the mechanisms for human health consequences of exposure to
physical and chemical agents in the environment.  As part of this mission, the
NIEHS initiated the Environmental Genome Project (EGP) to establish how
genetic polymorphisms influence susceptibility or resistance of individuals
following exposure to environmental agents. By understanding how genetic
polymorphisms in the general population affect individual responses to
environmental agents, scientists can better predict health risks and policy
makers will have a science-based framework for the development of
environmental policies to protect susceptible individuals.  The environmental
response genes that are under study as part of the EGP are in the following
classes: DNA repair pathway genes, genes that control the  metabolism
distribution of toxicants in the body,  genes for cell cycle control, genes
for cell death and differentiation, receptor genes, and genes for the signal
transduction systems controlling the expression of the genes in other
categories.  More information about the EGP is available at the following URL:  Molecular epidemiology studies
which determine the risk of birth defects from the interaction between these
genes, factors and exposures to environmental chemicals and other exposures
are of interest to NIEHS.

The National Institute of Dental and Craniofacial Research (NIDCR) is the
primary sponsor of oral biomedical and behavioral research and research
training in the United States.  As part of its mission, the NIDCR supports
research to understand the development of the craniofacial-dental structure,
and to identify the genetic and environmental contributions to craniofacial
anomalies.  Cleft lip and cleft palate are the most common craniofacial
anomalies, affecting approximately one out of every 500 live births.  It is
clear that there are a number of interacting mechanisms, including genetic and
environmental, that contribute to the risk of this malformation.  In addition,
there are numerous other craniofacial syndromes for which genetic mutations
and additional environmental risk factors can be identified.  Molecular
epidemiology studies which identify risk factors for developmental anomalies
of craniofacial structures are of interest to the NIDCR.  Additional
information about dental and craniofacial genetics is available on the NIDCR

The US Environmental Protection Agency (EPA) supports research both
intramurally and extramurally on the effects of environmental agents on
children"s health, including birth defects.  EPA"s efforts in this area have
focused on identifying environmental agents that cause birth defects and other
developmental disorders, the molecular mechanisms of birth defects, and how to
use mechanistic and other data in the risk assessment process.  In addition,
susceptibility factors that influence the response of individuals or
subpopulations is of great interest.  The EPA is also concerned with the
identification of exposure to environmental agents, and various exposure
factors, including the sources of exposure, bioavailability, route, timing,
and duration of exposure, and any lifestyle, behavioral, socioeconomic,
ethnic, gender, or age factors that influence the exposure of individuals or
subpopulations.  Prevention and intervention measures that can be taken to
reduce susceptibility and exposure are also of interest.

While not officially participating in this initiative, the National Heart Lung
and Blood Institute and the National Eye Institute, will consider an
application in response to this RFA that would be of relevance to their
programs on a case-by-case basis depending on the objectives of the study.

Research Objectives and Scope

This initiative encourages significant, innovative, and hypothesis-driven
research to study the biology and genetic susceptibility of human congenital
malformations.  Applicants should develop approaches that integrate
descriptive studies related to the causes and distribution of birth defects in
populations with the recent advances in molecular and developmental genetics,
genomics and bioinformatics, high throughput microscreening biotechnology, and
methodological and biostatistical tools.

Proposals to study the genetic susceptibility for malformations caused by or
associated with environmental agents or factors are solicited.  Investigators
are encouraged to: 1) develop interdisciplinary approaches involving
clinicians, epidemiologists, and basic biomedical scientists (e.g.,
geneticists, molecular and developmental biologists, etc.), and 2) collaborate
with existing population-based birth defects registries, databases, and
surveillance programs at the private, state, and Federal levels (especially
the Centers for Disease Control and Prevention Centers of Excellence for Birth
Defects).  The proposed studies should develop, adapt, and use approaches to
identify genetic contributions as well as environmental interactions and other
nongenetic determinants that contribute to various human congenital
malformations.  The approaches and findings from these studies should be used
to define, differentiate, and classify the genotypes and phenotypes of the
malformations being studied.  The long-term goals are to identify specific
genetic and environmental causes of structural birth defects in human
populations, focus on elucidating the underlying genetic and molecular
mechanisms responsible for the anomalies, and use the information to develop
effective screening, therapeutic, and prevention strategies.

Applications limited to traditional or descriptive epidemiology will be
considered non-responsive to this RFA.  Development and implementation of new
and innovative genetic and molecular biotechnology for identifying and
characterizing genetic and environmental factors responsible for the
epidemiology of malformations should be significant components of the
application. Similarly, state-of-the-art methods for the assessment of
environmental exposures, including sources, route, duration, and timing of
exposure, and lifestyle or other factors that influence exposure should be an
integral part of the application.  In addition, a component that includes
prevention or intervention strategies is encouraged.  The full complement of
structural birth defects, including skeletal, neural tube, and craniofacial
abnormalities are of interest.  Examples of research areas that are responsive
to this RFA are listed below.  However, the list is not intended to be all-
inclusive, but is designed merely to provide guidance and direction for

o  Research which seeks to understand the relationship between genetic
polymorphisms and risk of birth defects in the population.

o  Hypothesis-driven research of specific gene-environment interactions and
birth defects.  Use of biomarkers of exposure, effect and susceptibility are

o Epidemiologic studies which focus on classes of genes identified by the
Environmental Genome Program as environmental response genes and relevant
environmental exposures are encouraged. (see Background section).

o  Identification of genes and gene product interactions critical to
development, differentiation, patterning or other critical metabolic
characteristics  related to structural birth defects.  Examples include BMP,
MSX, homeobox genes.

o Identification of modifier genes influencing susceptibility and variability
of expression of structural birth defects.

o Interactions of factors controlling developmental processes (e.g., Sonic
hedgehog) with metabolites (e.g., cholesterol) in the formation of structural

o  Susceptibility to and molecular bases of disorders of cell migration and
differentiation, such as neural crest cells in developmental, neurological,
and craniofacial syndromes and disorders.

o Altered gene expression, imprinting, and epigenetic factors as effectors of
anomalous embryonic development resulting in aberrant fetal growth.

o Genetic basis for multifaceted, complex malformations and risk from
environmental exposures  for associated malformations.

o  Projects focusing on differences in susceptibility factors for
developmental anomalies in  minority populations or other susceptible
subgroups of the population.

o Environmental exposures and lifestyle factors of both the father and mother
and how these are linked to birth defects in the offspring.


Principal Investigators should budget funds to attend an annual NIH/EPA-
sponsored two-day meeting in Bethesda, MD.  Also attending this meeting will
be investigators, supported by a separate RFA, who are studying fundamental
developmental processes using animal models. These meetings will provide an
opportunity for the RFA-funded investigators to discuss the progress of their
research, exchange ideas and information, and foster collaborations that are
relevant to the research goals of the birth defects initiative.  This
requirement is designed to establish an interactive network of investigators
who are interested in multidisciplinary approaches to advancing our
understanding of the etiology of birth defects.

Quality Assurance

For any project considered for funding by the EPA involving data collection or
processing, conducting surveys, environmental measurements, and/or modeling,
EPA will require a statement on how quality processes or products will be
assured.  For awards that involve environmentally related measurements or data
generation, a quality system that complies with the requirements of ANSI/ASQC
E4, "Specifications and Guidelines for Quality Systems for Environmental Data
Collection and Environmental Technology Programs," must be in place.  EPA will
contact applicants being considered for EPA funding to obtain this statement.

ANSI/ASQC E4, "Specifications and Guidelines for Quality Systems for
Environmental Data Collection and Environmental Technology Programs" is
available for purchase from the American Society for Quality Control, phone
1-800-248-1946, item T55.  Only in exceptional circumstances should it be
necessary to consult this document.  There are EPA requirements (R-series) and
guidance (G-series) documents available which address in detail how to comply
with ANSI/ASQC E4.  These may be found on the Internet at  R-5, "EPA Requirements for Quality
Assurance Project Plans," and G-4, "Guidance for the Data Quality Objectives
Process," are particularly pertinent to the QA requirements.


It is the policy of the NIH that women and members of minority groups and
their subpopulations must be included in all NIH supported biomedical and
behavioral research projects involving human subjects, unless a clear and
compelling rationale and justification are provided 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 research involving human subjects should read the
"NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical
Research," which was published in the Federal Register of March 28, 1994 (FR
59 14508-14513) and reprinted in the NIH Guide for Grants and Contracts,
Volume 23, Number 11, March 18, 1994, and is available at the following URL


It is the policy of the NIH that children (i.e., individuals under the age of
21) must be included in all human subjects research, conducted or supported by
NIH, unless there are scientific and ethical reasons not to include them. 
This policy applies to all initial (Type 1) applications submitted for receipt
dates after October 1, 1998.

All investigators proposing research involving human subjects should read the
"NIH Policy and Guidelines on the Inclusion of Children as Participants in
Research Involving Human Subjects" that was published in the NIH Guide for
Grants and Contracts, March 6, 1998, and is available at the following URL

Investigators also may obtain copies of these policies from the program staff
listed under INQUIRIES.  Program staff may also provide additional relevant
information concerning the policy.


Prospective applicants are asked to submit, by July 1, 1999, a letter of
intent that includes a descriptive title of the proposed research, the name,
address, and telephone number of the Principal Investigator, the identities of
other key personnel and participating institutions, and the number and title
of this RFA.

Although a letter of intent is not required, is not binding, and does not
enter into the review of a subsequent application, the information that it
contains allows NICHD staff to estimate the potential review workload and
avoid conflict of interest in the review.

The letter of intent is to be sent to:

Dr. Deborah B. Henken
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
Executive Building, Room 4B01, MSC-7510
6100 Executive Boulevard
Bethesda, MD  20892-7510
Telephone:  (301) 496-5541
FAX:  (301) 480-0303


The research grant application form PHS 398 (rev. 4/98) is to be used in
applying for these grants.  These forms are available at most institutional
offices of sponsored research and from the Division of Extramural Outreach and
Information Resources, National Institutes of Health, 6701 Rockledge Drive,
MSC 7910, Bethesda, MD 20892-7910, telephone: (301) 710-0267, E-mail:, and on the Internet at:

The RFA label available in the PHS 398 (rev. 4/98) application form must be
affixed to the bottom of the face page of the application.  The label should
indicate the RFA number.  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

The sample RFA label available at: has been modified to
allow for this change.  Please note this is in pdf format.

Submit the signed, typewritten original of the application, including the
Checklist, plus three signed photocopies, in one package to:

BETHESDA, MD 20892-7710
BETHESDA, MD 20817 (for express/courier service)

At time of submission, two additional copies of the application must be sent

Dr. Scott Andres
Division of Scientific Review
National Institute of Child Health and Human Development
Executive Building, Room 5E03, MSC 7510
6100 Executive Boulevard
Bethesda, MD  20892-7510
Rockville, MD 20852 (for express/courier service)
Telephone:  (301) 496-1485
FAX:  (301) 402-4104

Applications must be received by August 20, 1999.  If an application is
received after that date, it will be returned to the applicant without review.

The Center for Scientific Review (CSR) will not accept any application in
response to this RFA that is essentially the same as one currently pending
initial review, unless the applicant withdraws the pending application. The
CSR will not accept any application that is essentially the same as one
already reviewed. This does not preclude the submission of substantial
revisions of applications already reviewed, but such applications must include
an introduction addressing the previous critique.


Upon receipt, applications will be reviewed for completeness by CSR, and for
responsiveness to the RFA by the NICHD, NIDCR, NIEHS and EPA staff. 
Incomplete applications will be returned to the applicant without further
consideration.  If staff finds that the application is not responsive to the
RFA, they will contact the applicant to determine whether to return the
application to the applicant or submit it for review in competition with
unsolicited applications at the next review cycle.

Applications that are complete and responsive to the RFA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
NICHD in accordance with the review criteria for scientific/technical merit
stated below.  As part of the initial merit review, a process may be used by
the scientific review group in which applications receive a written critique
and undergo a process in which only those applications deemed to have the
highest scientific merit will be discussed, assigned a priority score, and
receive a second level review by the National Advisory Child Health and Human
Development (NACHHD) Council, the National Advisory Dental and Craniofacial
Research (NADCR) Council, the National Advisory Environmental Health Sciences
(NAEHS) Council or programmatic review by the EPA"s National Center for
Environmental Research and Quality Assurance.

Review Criteria

The goals of NIH-supported research are to advance our understanding of
biological systems, improve the control of disease, and enhance health.  EPA"s
research programs focus on reduction of risks to human health and ecosystems
and on the reduction of uncertainty in risk assessment. In their 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.  Each of these
criteria will be addressed and considered in assigning the overall score,
weighting them as appropriate for each application.  Note that the application
does not need 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.

o  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

o  Approach: Are the conceptual framework, design, methods, and analyses
appropriate and adequate to accomplish the aims of the project?  Does the
applicant acknowledge potential problem areas and consider alternative

o  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?

o  Investigator: Is the Principal 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)?

o  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

In addition to the above criteria, in accordance with NIH policy, all
applications will also be reviewed with respect to the following:

o The adequacy of plans to include both genders, minorities and their
subgroups and children as appropriate for the scientific goals of the
research. Plans for the recruitment and retention of subjects will also be

o The reasonableness of the proposed budget and duration in relation to the
proposed research.

o The adequacy of the proposed protection for humans, animals or the
environment, to the extent they may be adversely affected by the project
proposed in the application.

The initial review group will also examine the provisions for the protection
of human subjects and the safety of the research environment.

Applications may also be reviewed with respect to the following:

o Availability of special opportunities for furthering research programs
through the use of unusual talent resources, populations, or environmental
conditions in other countries which are not readily available in the United
States or which provide augmentation of existing U.S. resources will be
considered in the review.

o Whether the scientific and technical merit of the research as proposed is
sufficient to achieve the objectives of this RFA.


Letter of Intent Receipt Date:    July 1, 1999
Application Receipt Date:         August 20, 1999
Date of Initial Review:           Oct/Nov 1999
Institute Council Review:         Jan/Feb 2000
Earliest Anticipated Award Date:  March 1, 2000


The anticipated date of award is March 1, 2000.  Factors that will be used to
make award decisions are as follows:

o  Scientific and technical merit of the proposed project as determined by
peer review,

o  Cost effectiveness of the proposed strategy,

o  Program priorities and program balance,

o  Availability of funds.


Written and telephone inquiries concerning this RFA are encouraged.  The
opportunity to clarify any issues or questions from potential applicants is

Direct inquiries regarding programmatic issues to:

Dr. Deborah B. Henken
Center for Research for Mothers and Children
National Institute of Child Health and Human Development
Executive Building, Room 4B01, MSC-7510
6100 Executive Boulevard
Bethesda, MD  20892-7510
Telephone:  (301) 496-5541
FAX:  (301) 480-0303

Dr. Judy Small
Craniofacial Anomalies and Injury Branch
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN-24J MSC 6402
Bethesda, MD  20892-6402
Telephone: (301) 594-2425
Fax: (301) 480-8318

Dr. Gwen W. Collman
Chemical Exposures and Molecular Biology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC 27709
Telephone: (919) 541-4980
Fax: (919) 541-4937

Dr. Chris Saint
National Center for Environmental Research & Quality Assurance, Room 51179
U.S. Environmental Protection Agency
1300 Pennsylvania Avenue
Washington, DC 20004
Telephone: 202-564-6909
Fax: 202-565-2448

Direct inquiries regarding fiscal and administrative matters to:

Mr. E. Douglas Shawver
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC-7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1303
Fax:  (301) 402-0915

Ms. Eileen Teng
Grants Management Office
National Institute of Dental and Craniofacial Research
Building 45, Room 4AN044
Bethesda, MD 20892
Telephone: (301) 594-4800
Fax: (310) 480-8301

Mr. David L. Mineo
Grants Management Officer
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC 27709
Telephone (919) 541-1373
Fax (919) 541-2860

Mr. John Puzak
U.S. Environmental Protection Agency (8701R)
Washington, DC 20460
Telephone: 202-564-6825
Fax: 202-565-2444

This program is described in the Catalog of Federal Domestic Assistance Nos.
93.865 (Research for Mothers and Children, National Institute of Child Health
and Human Development), 93.121 (National Institute of Dental and Craniofacial
Research), 93.113  (Biological Response to Environmental Health Hazards,
National Institute of Environmental Health Sciences), and 66.500
(Environmental Protection Agency).  Awards are made under authorization of the
Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by
Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants
policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 or by EPA under
the authority of 40 CFR parts 30 and 40.  This program is not subject to the
intergovernmental review requirements of Executive Order 12372 or Health
Systems Agency review.

The PHS and EPA strongly encourages all grant and contract 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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