MATHEMATICS COGNITION AND SPECIFIC LEARNING DISABILITIES
 
RELEASE DATE:  December 12, 2002  

RFA:  HD-02-031 (Reissued as RFA-HD-07-005)

National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)
Department of Education (DoED)
 (http://www.ed.gov/)
 
LETTER OF INTENT RECEIPT DATE:  February 28, 2003

APPLICATION RECEIPT DATE:  March 28, 2003
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanisms of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o 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

PURPOSE OF THIS RFA

The National Institute of Child Health and Human Development (NICHD), in 
partnership with the Office of Special Education and Rehabilitation Services 
(OSERS), U.S. Department of Education, invites innovative research grant 
applications designed to contribute new knowledge in the area of mathematical 
cognition and learning, with a focus on:  (1) normal development of 
mathematical proficiency (e.g., in basic calculation skills, mathematical 
conceptual understanding, comprehension, reasoning, procedural fluency, and 
strategic competence); (2) individual differences that moderate the 
development of mathematical proficiency (e.g., gender, ethnic or cultural 
factors, socio-economic status, personality, cognitive style); (3) specific 
learning disabilities in mathematics, including  definitional elements, 
classification, epidemiology, preventive strategies, early intervention, 
etiology, diagnosis, and treatment; and (4) combinations and relationships 
among these.  The topical domains of interest under the rubric of 
mathematical learning include, but are not limited to, basic calculation 
skills, mathematical conceptual understanding, comprehension, reasoning, 
procedural fluency, and strategic competence.  Of particular importance for 
this RFA is the discovery of cognitive, perceptual, behavioral, genetic, 
hormonal, and neurobiological mechanisms that are influential in the 
expression of learning abilities, individual difference factors, and specific 
learning disabilities in mathematics, as well as predictors of success and 
failure, along with the development of preventive and treatment approaches to 
ameliorate specific learning disabilities in mathematics.

This RFA will result in grants supporting multidisciplinary, integrated, 
coordinated programs of research (P01) and individual, possibly multi-site, 
multidisciplinary research project grants (R01).  The funded investigators 
will become part of a Mathematics Learning and Specific Learning Disabilities 
Research Network. 
 
RESEARCH OBJECTIVES

Background

The National Institute of Child Health and Human Development (NICHD), NIH, 
has had a long-standing interest in the study of individual differences in 
learning and specific learning disabilities.  Several recent national and 
international reports have called attention to the poor achievement record of 
our nation's children in the area of mathematics. The 1996 National 
Assessment of Educational Progress (NAEP) revealed that approximately 35 
percent of U.S. children in grades 4, 8, and 12 scored below the basic level 
in mathematics, and only about 45 percent scored at the basic level; the 
basic level is taken as indicating partial mastery of the knowledge and 
skills considered fundamental to mathematics proficiency.  The NAEP 
proficiency level indicates that students have the capability of completing 
challenging subject matter and are well prepared for the next level of 
schooling; only 21 percent of fourth graders and 24 percent of eighth graders 
scored at the proficient level.  Students whose math achievement is low are 
disproportionately African American, Hispanic, Native American, and those in 
urban or rural school districts.  While NAEP long-term trend data do indicate 
progress in the overall proficiency of U.S. students over the past three 
decades, the gap between African American and Caucasian students has widened 
in the 1990s, and this disparity does not appear to be wholly attributable to 
poverty or disadvantage.  

In the Third International Mathematics and Science Study (TIMSS) 
(http://nces.ed.gov/timss/), conducted by the National Center for Educational 
Statistics in cooperation with the National Science Foundation and 
international partners in 1994-1995 and published in 1995, there were some 
troublesome findings.  U.S. students scored above the international average 
in both mathematics and science at the fourth-grade level.  However, at the 
eighth-grade level, U.S. students performed below the international average, 
and in 12th grade, U.S. performance was among the lowest.  The TIMSS-R 
(Repeat) conducted in 1999-2000 assessed only eighth graders.  The results 
showed that U.S. children had moved from being similar to the international 
average in fourth grade in 1995 to being significantly below it in eighth 
grade in 1999.

Although educational research has provided some important insights into 
student learning, teacher development, and teaching strategies and 
technologies that enhance achievement in mathematics, the research has lacked 
a convergent knowledge base that can support systemic reform.  The limited 
use of educational research and development (R & D) for improving practice 
can be attributed in large part to under-investment in R & D and the 
consequent fragmentation of the current research effort in reading, 
mathematics, and science (see the 1999 National Research Council Report, "How 
People Learn: Bridging Research and Practice," http://www.nap.edu).  

Two recent national reports call for heightened research attention to the 
area of mathematics learning and learning difficulties.  In 2001, the 
National Research Council (NRC) of the National Academy of Sciences published 
"Adding It Up: Helping Children Learn Mathematics."  Comparing remediation in 
mathematics to that in reading, the NRC committee pointed out that there are 
few supplementary interventions and there is little targeted enrichment in 
mathematics that can help students overcome specific difficulties.  The 
committee also emphasized the crucial importance of school-based instruction 
for math, given that children are likely to spend little voluntary time 
exercising math skills outside the classroom.  In March 2002, the Rand 
Mathematics Study Panel, supported by the Office of Educational Research and 
Improvement (OERI), U.S. Department of Education, distributed a draft report 
for comment. This report, "Mathematical Proficiency for All Students: Toward 
a Strategic Research and Development Program in Mathematics Education," also 
emphasized the need for substantial research to develop an empirical base of 
evidence upon which new interventions can be based, and for research on their 
effectiveness once new interventions are designed and implemented.  The Rand 
report cites previous research efforts in mathematics as fragmented, 
disconnected from problems of practice, and non-cumulative.  In a call for 
well-conceived interventions, the report states that efforts at improving 
math education often proceed without adequate evidence and independent of 
theory about promising courses of action.  Both the NRC and Rand reports 
emphasize the importance of a more comprehensive view of mathematics 
learning. 

Specific learning disabilities now account for more than half of all students 
enrolled in special education, an increase of 22 percent over the past 25 
years.  In the past decade, the number of students ages six to 21 years 
identified with specific learning disabilities has increased by 38 percent. 
At the same time, efforts at remediation are not effective for most children. 
There appear to be several reasons for this dramatic increase in students 
placed in, and remaining in, special education:  the identification of 
students with specific learning disabilities is a highly subjective process 
that differs from state to state or school district to school district, and 
there are no uniform assessment procedures to determine what constitutes a 
specific learning disability or a specific learning disability in 
mathematics.  Students are generally identified only after a period of two to 
three years of school failure, although we know that the remediation of most 
learning difficulties is more challenging at later ages; and many teachers 
are not prepared to address the individual needs of students with specific 
learning disabilities.  Further, we do not have the assessment tools or 
procedures in place for early identification of children at risk for or 
suffering from specific learning disabilities, nor do we have the necessary 
information about specific learning capabilities and disabilities in 
mathematics, to design and tailor interventions for children who are 
experiencing learning difficulties. 

Much of current controversy over math instruction revolves around the timing 
and sequence of instruction on basic arithmetic operations and more complex, 
abstract mathematical and algebraic concepts.  Algebra is fundamental to math 
learning, enabling one to represent quantities and relationships, model 
situations, solve problems, and state and prove generalizations.  Algebra 
offers procedures and terminology for use in learning other areas of math. 
U.S. school children learn to count, add, subtract, multiply, and divide, 
first with whole numbers and then with decimals and fractions.  They use 
numbers to measure length, area, and volume of geometric shapes.  Algebraic 
concepts and procedures help them understand the systematicity within number 
systems, yet we often do not begin to teach children algebraic concepts until 
quite late in their schooling, and this knowledge is often not linked to or 
integrated with other areas of mathematics.  While there is insufficient 
research to fully characterize how children learn in all areas of 
mathematics, the complex, abstract aspects of conceptualization of 
mathematical relationships have been even more neglected than the learning 
and teaching of basic numerical skills and arithmetic calculations.  

There is a clear need for both basic and intervention research on the normal 
development of mathematical proficiency, individual differences in learning, 
and specific learning disabilities in mathematics.  Research is needed to 
elucidate how students learn mathematics, that is, how they develop 
proficiency with the central concepts of arithmetic and algebra, measurement, 
geometry, descriptive statistics, and probability; why some children have 
difficulty mastering these concepts and their fluent use in solving 
mathematical problems both in the classroom and in daily life; and how we can 
identify and remediate those who have or are likely to have learning 
difficulties in developing mathematical proficiency. 

Research Scope
 
Current knowledge related to how children develop mathematical proficiency, 
from the early preschool years through grade school and high school, is 
insufficient.  Gaps in the extant knowledge base on how children develop 
mathematical proficiency require systematic research that must address 
various domains of math learning.  Studies are needed that will map the 
developmental course of skill and concept acquisition in these domains, and 
will identify the optimal timing and sequence or integration of instruction 
in these domains.  At the same time, there is a need to initiate studies of 
specific learning disabilities in mathematics, particularly as they relate 
to:  (1) establishing reliable and valid definitions and classification 
systems that can differentiate specific learning disabilities in mathematics 
from other factors and conditions leading to underachievement in mathematics 
development; (2) designing reliable and valid measurement strategies and 
instruments to identify critical etiological factors (cognitive, linguistic, 
genetic, neurobiological, experiential) associated with impairments in 
mathematics; and (3) developing well-defined, evidence-based treatment 
interventions.  Advances in the application of structural and functional 
imaging modalities need to be expanded and applied to the study of brain-
behavior relationships relevant to disorders in the development of 
mathematics.  Likewise, neuroanatomical, neurophysiological, 
neuropsychological, and educational studies of development and disorders in 
executive function and social, nonverbal communication are critically needed 
in regard to the development of mathematical abilities, as well as the 
diagnosis, prevention, and remediation of specific learning disabilities in 
mathematics.

Research Focus

The research needs identified below are examples of research topics that 
applicants should consider when developing their responses to this 
solicitation.  The examples provided are not an exhaustive list but are 
offered as illustrations. 

Basic Research in the Development of Mathematical Proficiency 

It is not clear how the learning of numerical concepts, the development of 
higher level problem-solving abilities, and language and memory abilities are 
interrelated in the development of mathematical proficiency.  Longitudinal 
studies must be carried out to examine the differences in the growth 
trajectories of children with specific learning disabilities in math, low-
achieving children, and normally achieving children.  In addition, it would 
be useful to study the instructional and cultural practices that give rise to 
the identification and remediation of specific learning disabilities in math.

Longitudinal studies of the development of mathematical proficiency are 
especially encouraged, beginning either in the preschool period or in the 
early grades.  The roles of various component abilities in mathematical 
proficiency, and how these are best learned, must be understood in order to 
design, implement, and test the effectiveness of instructional approaches, 
both for instruction as part of a math curriculum and for intervention for 
specific learning disabilities in math.   

The Definition and Classification of Specific Learning Disabilities in Math

Under the Regulations for the Individuals with Disabilities Education Act 
(IDEA, P.L. 105-17) a specific learning disability is defined as a disorder 
in one or more of the basic psychological processes involved in understanding 
or in using language, spoken or written, that may manifest itself in an 
imperfect ability to listen, think, speak, read, write, spell, or to do 
mathematical calculations, including conditions such as perceptual 
disabilities, brain injury, minimal brain dysfunction, dyslexia, and 
developmental aphasia.  The term does not include learning problems that are 
primarily the result of visual, hearing, or motor disabilities, of mental 
retardation, of emotional disturbance, or of environmental, cultural, or 
economic disadvantage.  

A major prerequisite for studies concerning the definition and/or 
classification of specific learning disabilities in math pursuant to the 
present RFA is that they be carried out within a longitudinal developmental 
framework.  It should also be noted that such studies do not need to adhere 
to a priori assumptions reflected in current definitions of specific learning 
disabilities.  Additionally, the development of valid definitions requires 
that studies be conducted with representative groups of children over time 
and that they document, with robust measurements and measurement models, how 
individual differences among children emerge, change, respond to treatment, 
and influence further development.  In the process of forming definitions, a 
critical emphasis should be placed on the identification of valid inclusion 
criteria.  Moreover, any classification effort must be informed by a well-
developed model that incorporates behavioral, environmental, neurobiological, 
genetic, and hormonal influences and their relationships.  Finally, such 
efforts should be designed to identify and describe co-morbidities of 
specific learning disabilities in math with attentional problems, specific 
learning disabilities in reading, and specific genetic disorders affecting 
social, emotional, linguistic, and behavioral development.

o Current exclusionary definitions and assessment techniques may be invalid 
if discrepancy criteria are used.  For example, research has demonstrated 
that children with specific learning disabilities in reading, with and 
without a discrepancy between IQ and reading achievement, do not differ in 
information processing sub-skills (e.g., phonological and orthographic 
processing) that are critical to the reading of single words.  Likewise, 
genetic and neurophysiological studies have not indicated differential 
etiologies for children with specific learning disabilities in reading, with 
and without IQ-achievement discrepancies, and recent intervention studies 
indicate that the presence and magnitude of the discrepancy between IQ and 
reading achievement does not predict response to treatment.  Researchers have 
not yet explored whether discrepancies between IQ and achievement constitute 
valid markers in the area of mathematics, or whether discrepancies are 
worthwhile predictors of response to treatment/interventions in math domains.

o Given the lack of success in remediation to date, it appears that specific 
learning disabilities in math may reflect a persistent deficit rather than a 
developmental lag in basic arithmetic skills, but the nature of this deficit 
is not yet understood.  Studies are needed to determine whether there are 
definable subcategories of specific learning disabilities in math and, if so, 
what the most effective interventions might be for each. 

o Another important question is whether there are common cognitive/ 
neuropsychological origins for the difficulties with fact retrieval 
experienced by children who exhibit a co-morbidity of specific learning 
disabilities in math and reading.  It is important to be able to distinguish 
between children with true disability in math and other low-achieving 
children who are delayed but do not have a core neuropsychological deficit. 

Prevalence of Specific Learning Disabilities in Math

Longitudinal, epidemiological studies are needed to estimate the true 
prevalence of specific learning disabilities in math, whether alone or as a 
comorbid condition with other specific learning disabilities.  Such studies 
should identify linkages between specific learning disability in math, and 
sociocultural, economic, and demographic factors.  Of particular import are 
the effects of poverty on the failure to develop mathematical proficiency, 
and the identification of risk and protective factors within these contexts.  
The proportion of females to males affected has not been well investigated. 
It is not clear whether there is a gender-based difference in the prevalence 
of math difficulties and, if so, what the basis for such a difference might 
be.  While there is some suggestion that specific learning disabilities, most 
specifically those in reading, follow family lines, there is less specific 
evidence of a genetic component of specific learning disabilities in math. 
Questions related to severity, classroom behavior, teacher expectations and 
perceptions, and the influence of co-morbidities need to be addressed 
explicitly. 

Genetics of Specific Learning Disabilities in Math

o While there is currently a paucity of evidence regarding the genetic 
substrates of specific learning disabilities in math, future research efforts 
in this area can build on lessons learned and methods developed in the study 
of specific learning disabilities in reading.  For example, a multiple 
regression analytic procedure has been developed via NICHD support that 
allows for the analysis of the genetic etiology of deviant scores as well as 
individual differences in language/reading functions.  This is a highly 
unique and flexible methodology that can be extended to assess a wide range 
of possible main effects and interactions and to test for differential 
genetic and environmental influences.  Expansion of these types of models and 
procedures to the identification of heritability factors in specific learning 
disabilities in mathematics is strongly encouraged.

o Some data suggest that at least one type of a specific learning disability 
in reading can be linked to the HLA region of Chromosome 6, reflecting a 
possible association with autoimmune disorders.  Recent evidence obtained 
from twin and kindred siblings with severe deficits in reading performance 
show strong evidence for a Quantitative Trait Locus on Chromosome 6.  

These studies need to be continued and replicated in combination with the 
search for additional chromosomal regions, and studies improving on this type 
of methodology also should be applied to the identification of quantitative 
trait loci for deficits in cognitive components of mathematics development, 
written language, and attention.

Neurobiology (Neuroanatomy, Neurophysiology, Neuroimaging)

Basic research on the neurobiological underpinnings of math cognition is 
needed.  Given advances in neuroimaging technology, the timing is excellent 
to use these tools to clarify the relationships between brain 
structure/function and the acquisition of mathematical strategies and skills. 
Just as it has in the area of reading, the combination of functional 
neuroimaging and behavioral studies can help us examine the neural substrates 
of specific learning disabilities in math.  Recent advances in the 
application of functional neuroimaging modalities (e.g., fMRI) have indicated 
that neural activation patterns differ significantly between children with 
specific learning disabilities in reading and normal readers.  Ideally, 
convergent evidence will be gathered using any of a number of neuroimaging 
modalities (e.g., MRI, fMRI, MEG, MRS, Diffusion Tensor Imaging) and 
dependent measures to assess the neural organization of cognitive and 
linguistic skills critical to mathematics.  In addition, studies designed to 
delineate the neural substrates and changes necessary for the development of 
automaticity, procedural fluency, and mathematical proficiency/expertise are 
critically needed.  Given the findings of "neural signatures" for skilled 
reading and for specific learning disabilities in reading, it will be 
important to determine whether such neural signatures for mathematical 
abilities and disabilities can be found. 

Preliminary data suggest that changes in reading behavior produced by well-
defined early interventions are reflected in changes in neural activation in 
those brain regions implicated in the development of basic reading skills.  
Integrated intervention-neuroimaging studies need to be replicated for the 
area of mathematics and expanded to better understand the specific impact of 
behavioral perturbation on brain development and function, and to determine 
whether the intensity and duration of the intervention required to produce 
both behavioral and neural changes vary as a function of chronological age.

MECHANISM OF SUPPORT
 
This RFA will use the NIH Research Project Grant (R01) and Program Project 
Grant (P01) award mechanisms.  The R01 mechanism supports a focused research 
project conducted by one Principal Investigator, with or without 
collaborators.  If an application proposes a single, albeit large, multi-site 
project, it should be submitted as an R01.  In contrast, the P01 mechanism 
supports a broadly based, coordinated, collaborative, multi-disciplinary 
research program that has a well-defined central theme, research focus, or 
objective.  A P01 application must include at least three separate, but 
interrelated projects and usually at least one core resource.  Synergy among 
the component research projects comprising the P01 should result in greater 
scientific contributions than if each project were supported through separate 
R01 grants.  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 September 2003.

For R01 applications, this RFA uses just-in-time concepts.  It also uses the 
modular as well as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  Specifically, if 
you are submitting an R01 application with direct costs in each year of 
$250,000 or less, use the modular format.  Otherwise follow the instructions 
for non-modular research grant applications.

For P01 applications, you must follow the instructions available in the NICHD 
Program Project (P01) Guidelines at:  
http://www.nichd.nih.gov/funding/mechanism/p01_guide.cfm.  Any applicant 
considering applying for a program project grant is strongly encouraged to 
communicate with the program contact listed below under WHERE TO SEND 
INQUIRIES prior to submitting an application.

FUNDS AVAILABLE
 
The participating ICs and agencies intend to commit approximately $4 million 
in total costs [Direct plus Facilities and Administrative (F & A) costs] in 
FY 2003 to fund three to five new grants in response to this RFA:  NICHD, $3 
million; and ED, up to $1 million.  An applicant may request a project period 
of up to five years and a budget for direct costs of up to $500,000 for the 
R01 or up to $1 million for the P01.  Although the financial plans of the 
NICHD and Department of Education 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 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
o Faith-based or community-based organizations
 
INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS
 
Any established researcher 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
 
Meeting for Investigators
 
Principal Investigators of projects funded through this RFA will be expected 
to attend one meeting to share research designs and proposed measurement 
strategies, as well as methods and approaches to data collection and 
analysis, and to establish, where possible, core instrumentation intended to 
maximize the systematic collection of converging data across projects. 
Requests for funds for travel to these meetings, which will be held in the 
Washington D.C. area, should be included in the application budget request.

Application Considerations
 
In preparing applications in response to this RFA, applicants should ensure 
that the following methodological and organizational issues are addressed:

1. Research Population

The selection of the research population should be based upon the need to 
conduct integrated prospective, developmental, longitudinal investigations 
incorporating neurobiological, cognitive/behavioral, and early (and later) 
treatment/intervention studies with children who manifest specific learning 
disabilities in mathematics, alone or in combination with one or more of 
several domains to include oral language, basic reading skills, reading 
comprehension, and written expression, as well as deficits in attention.  
Within this context, longitudinal studies may be initiated with preschool and 
kindergarten children, with the children being followed as they enter and 
proceed through the early grades.  Cross-sectional studies of children with 
specific learning disabilities of different ages, ranging across the 
elementary and middle school age-spans, also should be considered, but such 
studies must be related meaningfully to the questions being asked within the 
longitudinal studies.

Children selected for study likely will vary across cultural, familial, 
ethnic, racial, economic, and other demographic characteristics that could 
influence development.  There likely will be subgroups and subtypes of 
children with significantly different patterns of demographic 
characteristics, academic deficits, different patterns of co-morbidity, 
levels of severity, and different psychological/cognitive processing 
deficits.  Therefore, applicants should consider research protocols that are 
capable of identifying well-defined subgroups and subtypes that exist within 
the sample.  Investigators also should consider casting the sampling net wide 
enough to insure a representative number of subtypes and contrast groups 
within the study population.  For example, of interest are studies of 
subtypes of children with specific learning disabilities of varying 
demographic characteristics, intellectual abilities, with primary deficits in 
mathematics who display no comorbid deficits, a single comorbid deficit, or a 
combination of comorbid deficits in attention, behavior, and social 
competencies, etc.  

2. Subject Selection Criteria

The samples for study must be defined rigorously so that complete replication 
can be accomplished.  Within this context, applicants should provide clearly 
documented and operationalized definitions for their subject selection 
criteria.  These definitions and criteria must be specified in an a priori 
manner.  The selection of "school-identified" or "clinic-identified" children 
with specific learning disabilities is clearly discouraged unless the 
demographic and diagnostic characteristics in these cases also matches the 
applicant's a priori established selection criteria.  Likewise, criteria for 
selection of contrast group(s) must be specified in an a priori manner.

All children selected for study must be defined with reference to age, 
gender, grade level, length of time in special education placement (if 
applicable), type of current special education placement (if applicable), 
previous special education placement(s) (if applicable) to include intensity 
and duration, ethnicity, socio-economic status, primary specific learning 
disability, comorbid disabilities, severity of disability, familial and/or 
genetic findings, physical/neurological findings, intellectual status, 
cognitive-linguistic status, neurophysiological and neuropsychological 
status, levels of academic achievement in oral language, reading, 
mathematics, and written language, and presence or absence of attention 
deficit disorder.  

3.  Measurement Criteria

Standardized tests, laboratory tasks, observational measures, interview 
schedules, and other assessment procedures (e.g., dynamic assessment 
procedures, case studies, ethnographic studies) must be selected on the basis 
of known reliability, validity, and appropriateness for the samples under 
study.  If reliability and validity of the 
measurement/assessment/observational procedures are initially unknown, the 
application must include specific plans for establishing these measurement 
properties.  The valid measurement of change over time is critical to much of 
the research solicited via this RFA since the study of developmental course 
and treatment effectiveness is of primary concern.  If instructional 
treatment studies are proposed, applicants should be aware of and employ 
robust procedures for separating treatment effects from the effects of 
development, in general.  The use of growth curve models and longitudinal 
data is encouraged, as is the collection of sufficient data prior to, during, 
and following the instructional/treatment study to allow for estimation of 
change over time.

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:

Daniel B. Berch, Ph.D.
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B05, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 402-0699
Fax:  (301) 480-0230
Email:  berchd2@mail.nih.gov 

Tom V. Hanley, Ed.D.
Office of Special Education and Rehabilitation Services
U.S. Department of Education
Switzer Building, Room 3526
330 C Street, SW
Washington, DC 20202-2461
Telephone:  (202) 205-8110
Fax:  (202) 205-8105
Email:  Tom.Hanley@ed.gov 

o Direct your questions about peer review issues to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1485
Fax:  (301) 402-4104
Email:  stretchr@mail.nih.gov 

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

Dianna Bailey
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6978 
Fax:  (301) 402-0915
Email: db405m@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 NICHD 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:

Daniel B. Berch, Ph.D.
Child Development and Behavior Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B05, MSC 7510
Bethesda, MD 20892-7510
Telephone:  (301) 402-0699
Fax: (301) 480-0230
Email:  berchd2@mail.nih.gov 

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant application 
instructions and forms (rev. 5/2001).  The PHS 398 is available at 
http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 435-0714, 
E-mail: GrantsInfo@nih.gov.
 
SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS:  Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular grant format.  The modular grant format simplifies the preparation of 
the budget in these applications by limiting the level of budgetary detail.  
Applicants request direct costs in $25,000 modules.  Section C of the 
research grant application instructions for the PHS 398 (rev. 5/2001) at 
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/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH:  Submit a signed, typewritten original of 
the application, including the Checklist, and three signed photocopies, in 
one package to:
 
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application must be 
sent to:

Robert Stretch, Ph.D.
Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5B01, MSC 7510
Bethesda, MD  20892-7510
Rockville, MD  20852 (for express/courier service)

APPLICATION PROCESSING:  Applications must be received by the application 
receipt date listed in the heading of this RFA.  If an application is 
received after that date, it will be returned to the applicant without 
review.
 
The Center for Scientific Review (CSR) will not accept any application in 
response to this RFA that is essentially the same as one currently pending 
initial review, unless the applicant withdraws the pending application.  The 
CSR will not accept any application that is essentially the same as one 
already reviewed. This does not preclude the submission of substantial 
revisions of applications already reviewed, but such applications must 
include an Introduction addressing the previous critique.

PEER REVIEW PROCESS
 
Upon receipt, applications will be reviewed for completeness by the CSR and 
responsiveness by NICHD and the Department of Education.  Incomplete and/or 
non-responsive applications will be returned to the applicant without further 
consideration.

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 NICHD in accordance with the review criteria stated below.  
As part of the initial merit review, all applications will:

o Receive a written critique
o Undergo a process in which only those applications deemed to have the 
highest scientific merit, generally the top half of the applications under 
review, will be discussed and assigned a priority score.
o Receive a second level review by the National Advisory Child Health and 
Human Development Council. 

REVIEW CRITERIA FOR R01 APPLICATIONS

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:  

o Significance 
o Approach 
o Innovation
o Investigator
o Environment

The scientific review group will address and consider each of these criteria 
in assigning your application's overall score, weighting them as appropriate 
for each application.  Your application does not need to be strong in all 
categories to be judged likely to have major scientific impact and thus 
deserve a high priority score.  For example, you may propose to carry out 
important work that by its nature is not innovative but is essential to move 
a field forward.

(1) Significance:  Does 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?

(2) 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?

(3) 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?

(4) 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)?

(5) 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, your 
application will also be reviewed with respect to the following:

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

o INCLUSION:  The adequacy of plans to include subjects from both genders, 
all racial and ethnic groups (and subgroups), and children as appropriate for 
the scientific goals of the research.  Plans for the recruitment and 
retention of subjects will also be evaluated. (See Inclusion Criteria 
included in the section on Federal Citations, below.)

o DATA SHARING:  The adequacy of the proposed plan to share data.

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

REVIEW CRITERIA FOR PROGRAM PROJECTS (P01)

Peer review of scientific and technical merit focuses on three areas: (1) 
review of the individual component projects; (2) review of the individual 
cores; and (3) review of the program as an integrated effort and the overall 
merit of the program.  P01 applications submitted in response to this RFA 
will be evaluated according to the review criteria described in the NICHD P01 
Guidelines, available from the contacts listed under WHERE TO SEND INQUIRIES, 
above, and at http://www.nichd.nih.gov/funding/mechanism/p01_guide.cfm.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:  February 28, 2003
Application Receipt Date:  March 28, 2003
Peer Review Date:  July 2003     
Council Review:  September 2003
Earliest Anticipated Start Date:  September 2003

AWARD CRITERIA

Criteria that will be used to make award decisions include:

o Scientific merit (as determined by peer review)
o Availability of funds
o Programmatic priorities
 
REQUIRED FEDERAL CITATIONS

INCLUSION OF WOMEN AND MINORITIES IN CLINICAL RESEARCH:  It is the policy of 
the NIH that women and members of minority groups and their sub-populations 
must be included in all NIH-supported clinical research projects unless a 
clear and compelling justification is provided indicating that inclusion is 
inappropriate with respect to the health of the subjects or the purpose of 
the research. This policy results from the NIH Revitalization Act of 1993 
(Section 492B of Public Law 103-43).  

All investigators proposing clinical research should read the AMENDMENT "NIH 
Guidelines for Inclusion of Women and Minorities as Subjects in Clinical 
Research - Amended, October, 2001," published in the NIH Guide for Grants and 
Contracts on October 9, 2001 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines is available at 
http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm.
The amended policy incorporates the use of an NIH definition of clinical 
research; updated racial and ethnic categories in compliance with the new OMB 
standards; clarification of language governing NIH-defined Phase III clinical 
trials consistent with the new PHS Form 398; and updated roles and 
responsibilities of NIH staff and the extramural community.  The policy 
continues to require for all NIH-defined Phase III clinical trials that: a) 
all applications or proposals and/or protocols must provide a description of 
plans to conduct analyses, as appropriate, to address differences by 
sex/gender and/or racial/ethnic groups, including subgroups if applicable; 
and b) investigators must report annual accrual and progress in conducting 
analyses, as appropriate, by sex/gender and/or racial/ethnic group 
differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN 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.

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 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.

URLs IN NIH GRANT APPLICATIONS OR APPENDICES:  All applications and proposals 
for NIH funding must be self-contained within specified page limitations. 
Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) 
should not be used to provide information necessary to the review because 
reviewers are under no obligation to view the Internet sites.  Furthermore, 
we caution reviewers that their anonymity may be compromised when they 
directly access an Internet site.

HEALTHY PEOPLE 2010:  The Public Health Service (PHS) is committed to 
achieving the health promotion and disease prevention objectives of "Healthy 
People 2010," a PHS-led national activity for setting priority areas.  This 
RFA is related to one or more of the priority areas.  Potential applicants 
may obtain a copy of "Healthy People 2010" at 
http://www.health.gov/healthypeople.

AUTHORITY AND REGULATIONS:  This program is described in the Catalog of 
Federal Domestic Assistance Nos. 93.865 and 84.324 and is not subject to the 
intergovernmental review requirements of Executive Order 12372 or Health 
Systems Agency review.  Awards are made under authorization of Sections 301 
and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and 
administered under NIH grants policies described at 
http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 
42 CFR 52 and 45 CFR Parts 74 and 92.  

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


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