EARLY CHILDHOOD EDUCATION AND SCHOOL READINESS PLANNING GRANTS
 
RELEASE DATE:  January 7, 2002
 
RFA:  RFA-HD-02-005

PARTICIPATING INSTITUTES AND CENTERS (ICs):

National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)
National Institute of Mental Health (NIMH)
 (http://www.nimh.nih.gov)
Administration for Children and Families (ACF)
 (http://www.acf.dhhs.gov)
Assistant Secretary for Planning and Evaluation (ASPE)
 (http://www.aspe.dhhs.gov)
Department of Education
 (http://www.ed.gov/)
 
Letter of Intent Receipt Date:  April 15, 2002
Application Receipt Date:       May 14, 2002
 
THIS RFA CONTAINS THE FOLLOWING INFORMATION

o Purpose of this RFA
o Research Objectives
o Mechanism(s) of Support 
o Funds Available
o Eligible Institutions
o Individuals Eligible to become Principal Investigators
o Special Requirements
o Where to Send Inquiries
o Letter of Intent
o Submitting an Application
o Peer Review Process
o Review Criteria
o Receipt and Review Schedule
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS RFA
 
Participating ICs/Agencies intend jointly to stimulate sustained, 
multidisciplinary, programmatic research on the effectiveness and efficacy of 
existing, modified or newly developed comprehensive and integrative curricula 
or integrative curriculum modules for use with children from birth to age 
five to promote learning and development across domains associated with 
school readiness.  These domains include:  language and communication; 
emerging and early literacy; early mathematical knowledge; cognitive skills 
and conceptual knowledge, to include science concepts; self-regulation of 
attention, behavior and emotion; social competency; fine and gross motor 
development; motivation and positive dispositions toward learning.  A special 
emphasis is on approaches that promote language, emerging and early literacy, 
early mathematical knowledge, and other aspects of cognitive development, 
while simultaneously developing self-regulatory and social competencies, 
motivation and positive dispositions toward learning, especially for children 
at risk for school failure.  This solicitation encompasses the identification 
of comprehensive strategies for use with children from birth to promote the 
development of linguistic, social, communicative, cognitive, and perceptual-
motor competencies that are the early bases of learning during the 
preschool years.

A primary goal is to understand the complex combination of individual and 
contextual factors that interact with curriculum components to influence 
effectiveness.  The research stimulated should produce knowledge that can be 
used systematically to educate the early childhood education and care 
workforce, parents, and other adults responsible for children's learning in 
formal and informal early childhood education and care settings.  This 
solicitation encourages the establishment of researcher-practitioner 
partnerships in the context of early childhood programs developed at federal, 
state, and community levels, to include Head Start, Early Head Start, or 
other state early childhood initiatives serving populations at risk for 
school failure, as well as partnerships with center-based child-care, and 
family day care settings.

This RFA will support activities necessary to prepare for a future 
solicitation for complex, large-scale, multi-site effectiveness trials. 
Obtaining a planning grant through this RFA is not required to respond to the 
future solicitation.
 
RESEARCH OBJECTIVES

Background

During the last decade, scientists and practitioners across disciplines 
relevant to child development, early childhood education, and early childhood 
intervention have worked toward a conceptualization of school readiness 
intended to guide research and practice.  To participate in and benefit from 
formal schooling, children need to be physically healthy and develop strong 
foundations across multiple, broadly defined domains that include: language 
and communication; emerging and early literacy; early mathematical knowledge; 
cognitive skill and conceptual knowledge; social competency; self-regulation 
of attention, behavior, and emotion; motivation to learn, and positive 
dispositions toward learning. However, at entry to kindergarten, children 
from poor families and minority groups often show fewer of the competencies 
and dispositions associated with school achievement.  Early delays are 
quickly magnified as these children move through the early grades and become 
more likely than their more affluent and majority peers to score lower on 
tests of academic achievement, such as reading skill, receive special 
education, repeat school grades, and be diagnosed with mental retardation and 
learning disabilities.

Most educators and scientists across relevant disciplines agree that early 
childhood is a critical time to begin preventing achievement gaps.  
Comprehensive services programs intended to close these gaps typically offer 
a combination of child-focused early childhood education, parent-focused 
intervention, and other health and social services.  One of the highest 
priorities for those programs is ensuring that all children have the early 
experiences necessary for developing the emerging literacy, language, and 
cognitive skills essential for succeeding in school.  However, data derived 
from recent evaluations of such programs underscore the need for approaches 
to early childhood education and care that more systematically develop this 
knowledge.  Addressing this need is especially crucial given the rapid 
emergence of state initiatives for universal preschool and other programs 
targeting poor children from birth to five, and given the increased use of 
formal and informal out-of-home group care.

Research indicates that to structure environments and interactions that 
promote learning, adults need strategies for developing positive 
relationships with children, and for developing children's motivation, social 
competency, and self-regulation of attention, behavior, and emotion, 
including strategies for classroom or group management that reduce aggressive 
and disruptive behavior.  Thus, scientifically validated approaches are 
needed that the adults responsible for promoting children's learning and 
development in each early childhood education and care setting can implement 
reliably to develop the full range of knowledge, skills, dispositions, and 
behaviors essential for meeting the challenges of kindergarten and the 
early grades.

Overview of Relevant Research
 
A large body of evidence across relevant disciplines provides a basis for 
addressing this need.  For example, developmental sequences have been 
identified that specify the early content knowledge, skills, and dispositions 
from birth to age five that are predictors or precursors of learning and 
development in each domain associated with school achievement. Strategies 
have been identified for structuring environments and interactions with 
adults and peers to promote learning and development in these domains, and 
for encouraging engagement in and positive dispositions toward learning 
activities.  Qualities of children's social relationships with peers and 
adults have been identified that influence the quality and potential 
effectiveness of adult-guided interactions intended to promote learning.  
Intensive early childhood interventions targeted toward children and families 
in poverty have been shown to influence a variety of school-related outcomes, 
including cognition and language, social competency, and regulation of 
emotion and behavior.  The most effective interventions are implemented with 
strong fidelity by trained staff, include goal-oriented curricula informed by 
child development research, ensure that children's nutritional and other 
health needs are met, and often include a parent-focused component to support 
children's development.

Despite a large relevant research base, gaps remain between current knowledge 
and the knowledge required to provide the education and professional 
development essential for structuring environments and interactions that 
reliably promote learning and development across all domains that are 
foundations of school achievement.  For example, many current approaches to 
early childhood education and care and models for intervening with parents 
have a general basis in theories of development; however, specific 
combinations of strategies embedded in these approaches have not been 
evaluated to determine which components produce specific learning and 
development outcomes.  In addition, many existing curriculum models and 
parent-interventions focus on only one or two content areas, typically either 
language and early literacy skills or social-emotional competence, although 
learning and development is connected across cognitive, linguistic, 
affective, and social domains, and despite the fact that all are essential 
for promoting children's preparation for school.

Moreover, general styles of interacting with children often have been 
polarized into direct instruction and child-centered approaches each with 
exclusive characteristics, further separating goals for early childhood 
education into cognitive-linguistic and social-emotional domains.  That is, 
direct instruction approaches have been too generally associated with 
directive, punitive and controlling behavior that pressures children to 
engage in developing knowledge and learning specific skills before reaching 
a level of maturity believed to be essential for benefiting from the 
activity.  Child-centered approaches have been too generally associated with 
warm, responsive, nurturing care to promote social development and emotional 
health, and little emphasis on developing language, early literacy and 
cognitive skills.  The most current and prevalent judgment of scientists and 
practitioners is that adults need a full repertoire of strategies for 
intentionally structuring environments and guiding interactions to meet 
children's individual needs for learning across all domains.
 
Sustained, programmatic research is needed that builds upon the most rigorous 
scientific evidence across disciplines to identify comprehensive and 
integrative approaches that are enjoyable and engaging to children, that are 
responsive to children's individual characteristics and needs, and that 
develop the full range of knowledge, skills, and dispositions known to lead 
to early school adaptation and achievement.

Research Scope
 
To address this need, this RFA encourages planning for sustained, 
programmatic, multidisciplinary research to evaluate the effectiveness of 
existing, modified, or newly developed comprehensive and integrative 
curricula or integrative curriculum modules for use with children from birth 
to age five.  The curriculum should be designed to promote learning and 
development in two or more of the following domains: language and 
communication; emerging and early literacy; early mathematical knowledge; 
cognitive skills and conceptual knowledge, to include science concepts.  Each 
application should focus on one or more of the social, affective, and 
motivational components of school readiness to determine how implementation 
also facilitates (1) self-regulation of attention, behavior, and emotion, (2) 
social communication and competency, (3) motivation and positive dispositions 
toward learning.

In addition to supporting the evaluation of curricula for use in center-based 
settings, this RFA supports planning for the evaluation of existing, 
modified, or newly developed, comprehensive and integrative curricula or 
curriculum modules intended for use by parents or other adults responsible 
for promoting children's learning and development in family day care and 
informal care settings.  These may be evaluated for independent use or as a 
component linked to a comprehensive and integrative curriculum or curriculum 
module implemented in a center-based setting.

For the purposes of this RFA, the term "curriculum" refers to: (1) a set of 
goals and objectives for the content knowledge, skills, behaviors, and 
attitudes to be promoted; (2) a set of benchmarks for guiding and assessing 
incremental progress toward attaining these goals and objectives; (3) a 
repertoire of strategies that adults can use in a dynamic and flexible manner 
to intentionally structure environments and interactions to meet curriculum 
goals; and (4) supporting materials to facilitate the implementation of those 
strategies.  The term is defined broadly to encompass comprehensive 
strategies for intentionally structuring environments and interactions from 
the time of birth to develop early linguistic, social, communicative, 
perceptual-motor, cognitive skills, and conceptual knowledge that are 
foundations of learning during the later preschool years.  The goals, 
objectives, and benchmarks should be justified on the basis of the most 
rigorous scientific knowledge concerning developmental continua, progressions 
or sequences, and processes and conditions for promoting children's progress 
in each targeted domain.

Applicants must build on existing evidence across relevant disciplines to 
design evaluations that answer these overarching questions:
 
o Which components of integrative curricula or integrative curriculum 
modules, and which combinations of associated adult-guided interactions are 
necessary to promote learning and development, for which children, in which 
settings, and under which conditions?
 
o What education, training, and administrative or other structural supports 
are needed to implement the approach fully and effectively?
 
o What education and professional development models provide the knowledge 
and skill required for full and effective implementation?

Research Focus

A major goal of this solicitation is to plan multidisciplinary, programmatic 
research that can specify which approaches are most or least beneficial for 
which children, in which circumstances, and why.  Therefore, a developmental-
ecological conceptual approach is strongly encouraged to guide the design of 
effectiveness trials that can address these questions:
  
o What are the mediating processes through which specific curriculum 
components influence learning and development in each domain?

o Which individual difference factors and multiple levels of contextual 
factors act alone or in combination to influence child outcomes, fidelity of 
implementation, or replication and generalization of the results?
 
Contextual factors may include but are not limited to characteristics of 
parents, homes, families, communities, schools, teachers, administrators, 
classrooms, and policies at multiple levels, to include program 
administrative policies or broader local, state or federal policies that 
affect intervention implementation or benefit accrued from the intervention.  
Individual difference factors may include but are not limited to initial 
levels of competence, rates of learning, gender, temperament, pre-maturity, 
behavioral disorder, illness, and disability. Applicants are especially 
encouraged to consider what adaptations to the approach are necessary for 
children with disabilities to participate in and benefit from the curriculum. 
Though promoting physical health is not a necessary component of the 
interventions solicited by this RFA, all applicants should consider that 
factors such as good prenatal care, adequate nutrition, protection from 
disease and infection, lack of exposure to toxins and early detection of 
biological/physiological impairments have the potential to facilitate early 
learning and moderate the effectiveness of interventions intended to promote 
school readiness.

o What education and professional development are required to meet the needs 
of diverse populations, to include children with disabilities and children 
from varied minority, ethnic and cultural backgrounds? How do potential 
discrepancies between home and school environments concerning goals for and 
approaches to promoting children's learning and development affect 
implementation and effectiveness of the intervention?
 
o What are the social competencies, regulatory behaviors, motivational 
dispositions and qualities of children's social relationships with adults and 
peers that promote or impede the effectiveness of approaches intended to 
promote the development of language, emerging literacy, early mathematical 
knowledge, and other aspects of cognitive development?  What education, 
professional development, and structural supports are needed to help adults 
establish and maintain the positive relationships with children and parents 
that are essential for implementing the curriculum effectively?

Within the context of these planning activities, applicants may focus on the 
early assessment and diagnosis of emotional and behavioral problems, and 
mental disorders that may affect social and emotional development and 
readiness for school, and risk or resilience for mental disorder.  
Applications with this focus should distinguish components of the curriculum 
that may be effective for the prevention and/or treatment of emotional and 
behavioral problems in young children, and mental disorders that affect early 
school functioning such as anxiety, depression, inattention, hyperactivity, 
and impulsivity, and pervasive developmental disorders.  These applications 
should be responsive to recommendations of the National Advisory Mental 
Health Council in the report "A Blueprint for Change: Research on Child and 
Adolescent Mental Health" (see http://www.nimh.nih.gov/childhp/blueprint.cfm), 
and should consider the report entitled " Off to a Good Start: Research on the 
Risk Factors for Early School Problems and Selected Federal Policies Affecting 
Children's Social and Emotional Development and Their Readiness for School" (see 
http://www.nimh.nih.gov/childhp/goodstart.cfm), that was commissioned in part by 
the co-sponsors of this initiative.

This list is not exclusive or exhaustive, and it is not expected that each 
application will address the entire range of issues discussed in this RFA.  
However, applicants must plan proposals and establish the multidisciplinary 
expertise required to: (1) answer each overarching question listed under 
Research Scope, and (2) identify and develop conceptual models, research 
designs, and methodological approaches appropriate for specifying the 
components, processes, and conditions responsible for the short- and long-
term effectiveness of the intervention.

Activities to be Supported
 
This RFA will support activities necessary to prepare for large 
multidisciplinary individual research projects or coordinated multiple 
project approaches to complex, large-scale, multi-site effectiveness trials. 
Specific activities supported include, but are not limited to:

o Establishment of multidisciplinary scientific collaborations;

o Identification of sites and establishment of researcher-practitioner 
collaborations;

o Ascertainment of research populations and identification of appropriate 
sampling strategies;

o Selection, validation, development, and piloting of relevant 
instrumentation, especially for use with diverse populations, to include 
children with disabilities;
 
o Development of detailed conceptual models to guide research design and 
hypothesis testing;

o Design of protocols for well-controlled randomized experiments and/or 
quasi-experiments, to include identification of feasible strategies for 
achieving randomization; establishing criteria for matching comparison 
groups; strategies for minimizing selective attrition; and strategies for 
maintaining and evaluating fidelity of the intervention.

o Development of plans for data analysis to include identification of 
quantitative expertise required for analyzing complex multivariate data sets 
and using state of the art techniques for measuring change;
 
o Development of plans to specify complete costs of implementing the 
intervention in additional settings, including all materials and professional 
development, and plans to conduct cost-benefit analyses as appropriate;

o Identification of administrative facilities, procedures, and on-site and 
off-site personnel.

Application Considerations
 
Each applicant should ensure that the application includes plans to address 
the following methodological and organizational issues:

o Research Population
 
This RFA especially encourages the establishment of researcher-practitioner 
partnerships with early childhood education and care settings that have been 
developed at federal, state, or community levels, including but not limited 
to Head Start, Early Head Start, or other state early childhood initiatives 
for younger children, center-based child care, family day care and informal 
child-care that include populations at risk for school failure.  It is 
anticipated that samples will include large numbers of individuals who are 
from minority groups and/or lower socio-economic levels to ensure that 
findings will be useful for addressing educational disparities that exist for 
these groups.  Applications may include focused study of subgroups that meet 
the definition of preschoolers with disabilities under Part B of the 
Individuals with Disabilities Education Act (IDEA) and infants and toddlers 
who are served under Part C of IDEA.  Applicants are encouraged to select a 
core research population that provides the opportunity to conduct 
longitudinal analyses on subgroups of samples large enough to test complex 
interactions among individual and contextual factors that promote or impede 
intervention effectiveness.
 
o Selection Criteria

To facilitate complete and independent replication, applicants must plan to 
rigorously define samples and subgroups using clear operational definitions, 
and to describe and justify subject selection criteria with respect to sample 
characteristics that include, but are not limited to, age, gender, ethnicity, 
socioeconomic status, geographic region, and disability.  Applicants are 
expected to plan to identify detailed eligibility and exclusion criteria for 
participants and research sites.  Applications should include plans to 
thoroughly describe all relevant structural and process features of the 
intervention setting.  These features include but are not limited to staff 
configuration, availability of various services or resources, education and 
training backgrounds of those responsible for implementing the intervention, 
and existing approaches to providing education and care.

o Approaches to Integration
 
Current approaches to integration differ in the explicitness and degree of 
integration both within a single domain, such as language, or literacy, or 
math, and across cognitive-linguistic and social-emotional domains.  One 
intention of this program is to encourage multidimensional approaches to 
promoting and evaluating the full set of knowledge, skills, and dispositions 
within each domain, from the onset of initial foundational competencies in 
each domain through the development of advanced forms.  Therefore,, existing 
curricula targeting one or more of the cognitive-linguistic domains may be 
further developed, implemented, and evaluated with consideration of how the 
implementation facilitates one or more of the following: (1) self-regulation 
of attention, behavior, and emotion, (2) social communication and competency, 
(3) motivation and positive dispositions toward learning.  Likewise, 
approaches that currently target social-emotional competence may be further 
expanded to target two or more of the cognitive-linguistic domains.
 
Further development and evaluation of other widely used and advocated, but 
understudied, approaches to integration also are encouraged.  For example, 
goals for learning across two or more distinct domains, such as literacy and 
math, or literacy, language, and fine and gross motor development, are 
sometimes incorporated into a single curriculum module.  Such approaches 
include but are not limited to project or theme-based approaches, typically 
implemented with the intention of building on a child's expressed interest in 
a particular area.  This initiative encourages further development and 
evaluation of these curricula, under the condition that the approach is 
consistent with the definition of "curriculum" and all other requirements 
provided under Research Scope, above.

These examples of integrative approaches are neither inclusive nor 
exhaustive.  Applicants should provide, define, and justify their particular 
approach to integration in detail on the basis of the most rigorous and 
relevant scientific evidence supporting its potential for effectively 
promoting early school achievement.

o Research Methodology and Approaches
   
Applicants should design randomized experiments and/or well-controlled quasi-
experiments, combined as appropriate with detailed observational, micro-
genetic, survey, and qualitative methodologies.  Qualitative methodologies 
are encouraged as a complement to quantitative methodologies to aid in the 
identification of factors that explain intervention effectiveness or 
ineffectiveness, to include factors that affect the fidelity of 
implementation, or the replication and generalization of intervention 
effects.  Applicants may establish criteria for evaluating the 
trustworthiness and credibility of data obtained with qualitative methods, 
the transferability of the data, and adequacy of the data for testing the 
hypothesis.
  
Systematic planned variations are encouraged to test the value-added 
contribution that each intervention component makes to children's outcomes.  
Therefore, applicants may consider designs that specify, as appropriate to 
the focus of the project, the unique contribution to outcomes made by (1) 
each component embedded within the curriculum module, (2) each curriculum 
module embedded within the comprehensive curriculum, and (3) each parent-
implemented intervention linked to a comprehensive integrative curriculum or 
integrative curriculum module offered in a center-based setting.

Longitudinal designs or combinations of cross-sectional and longitudinal 
designs will be necessary to meet the overarching objective of this research. 
The use of recently developed statistical methodologies is encouraged for 
analyzing how individual and contextual factors interact with intervention 
components to influence individual developmental trajectories that identify 
individual rates and patterns of change.  Designs should allow evaluation of 
how the duration, intensity, and timing of children's participation in the 
intervention influence short- and long-term outcomes.

One goal of this RFA is to support plans for longitudinal studies that 
evaluate long-term outcomes as children transition from preschool into 
kindergarten and enter formal schooling.  Applications with this focus should 
include plans to identify appropriate functional measures of children's 
school adaptation and achievement to distinguish which components of the 
early childhood intervention predict specific school-related outcomes.  
Characteristics of kindergarten and early elementary school environments 
should be evaluated to determine how these potentially moderate long-term 
outcomes.  All applications are not required to plan for following children 
through the period of transition to formal schooling. An equally important 
focus is on the conditions under which the purposeful structuring of 
environments and interactions with infants and toddlers provide foundations 
for developing the knowledge, skills, attitudes, and behaviors that are the 
basis for learning and development during the later preschool years.
    
Applicants are encouraged to consider that the implementation of a curriculum 
designed to produce specific outcomes can have unintended positive and 
negative effects.  For example, some approaches to integration may result in 
enjoyable activities for children but not meet the goal of developing the 
specific knowledge or skills essential for early school achievement and for 
which the approach was designed.  However, highly structured approaches with 
a very narrow focus, such as learning the alphabet, can have unintended 
negative consequences, such as a reduction in the use of diverse and complex 
language that research shows is crucial for learning and development.  
Therefore, applicants are encouraged to evaluate outcomes within and across 
domains both to identify the full range of positive, intended effects and to 
identify any probable unintended outcomes of the implementation.
 
o Measurement
 
Applicants may propose to identify, further validate, and/or develop 
essential instrumentation for evaluating intervention effects on children's 
learning and development.  Applicants should select multiple measures of 
child development and learning from multiple perspectives to include parent 
and teacher report as well as direct observations and assessments, which 
should be included whenever appropriate and possible.  Applicants should 
select and/or develop instrumentation linked directly to operationally 
defined curriculum goals for learning and development.  Direct observations 
and individual assessments may be developed that measure transitions in 
learning and development from the onset of initial competencies through more 
advanced forms.

Appropriate instrumentation may be unavailable either because data do not 
exist to judge appropriate usage or because instruments have unacceptable 
psychometric properties for subgroups expected to participate in future 
large-scale trials.  In this case, applicants may plan to validate existing 
measures of children's learning and development for use with diverse 
populations, to include direct assessments and observations as well as parent 
and teacher reports.

Standard observation assessments may be developed for intended use by trained 
adults to evaluate each child's progress and to adjust implementation 
strategies to meet curriculum goals.  In addition, applicants may identify or 
develop standard observational assessments to evaluate the fidelity of 
implementation.

MECHANISM OF SUPPORT
 
This RFA will use the NIH Exploratory/Developmental Research Grant (R21) 
award mechanism.  As an applicant you will be solely responsible for 
planning, directing, and executing the proposed project.  This RFA is a one-
time solicitation.  Plans developed via support from this RFA can inform 
future solicited and unsolicited applications that propose large-scale 
randomized trials and quasi-experiments that meet the objectives of this 
research initiative.  The anticipated award date is September 2002.

This RFA uses just-in-time concepts.  It also uses the modular budgeting 
format. (see https://grants.nih.gov/grants/funding/modular/modular.htm).   
Specifically, all applications with direct costs in each year of $250,000 or 
less must use the modular format.

FUNDS AVAILABLE
 
The participating ICs and agencies intend to commit approximately $2.5 
million (total costs) in FY 2002 to fund 10 to 12 new grants in response to 
this RFA:  NICHD, $1 million; ACF, $1 million; ASPE, $250,000; and NIMH 
$250,000. An applicant may request a project period of one year and a budget 
for direct costs of up to $125,000.  Although the financial plans of the ICs 
and agencies 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 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.  If research organizations 
involve curriculum developers or distributors in the project, objectivity of 
the evaluation must not be jeopardized. 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 conceptual frameworks, to share approaches to 
developing and implementing comprehensive and integrative curricula, and to 
establish core instrumentation intended to maximize the systematic collection 
of converging data across projects.  Requests for funds for travel to this 
meeting should be included in the application budget request.

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:

Melissa K. Welch-Ross, 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) 435-2307
FAX:  (301) 480-7773
E-mail:  rossm@mail.nih.gov

Michael L. Lopez, Ph.D.
Director, Commissioner's Office of Research & Evaluation
Administration on Children, Youth & Families
330 C Street, SW, Room 2128
Washington, DC  20447
Telephone:  (202) 205-8212
FAX:  (202) 205-9721
E-mail:  milopez@acf.dhhs.gov

Cheryl A. Boyce, Ph.D.
Developmental Psychopathology and Prevention Research Branch
Division of Mental Disorders, Behavioral Research and AIDS
National Institute of Mental Health
6001 Executive Blvd., Room 6200, MSC 9617
Bethesda, MD  20892-9617
Telephone:  (301) 443-0848
FAX:  (301) 480-4415
E-mail:  cboyce@nih.gov

o Direct your questions about peer review issues to:

Robert Stretch, Ph.D.
Acting Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 5E03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1485
FAX:  (301) 402-4104
E-mail:  stretchr@mail.nih.gov

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

Ms. Mary Daley
Grants Management Branch
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 8A17, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 496-1305
FAX:  (301) 402-0915
E-mail:  md74u@nih.gov

Ms. Diana S. Trunnell
Grants Management Branch
National Institute of Mental Health
6001 Executive Boulevard, Room 6115, MSC 9605
Bethesda, MD  20892-9605
Telephone:  (301) 443-2805
FAX:  (301) 443-6885
E-mail:  Diana_Trunnell@nih.gov
 
LETTER OF INTENT
 
Prospective applicants are asked to submit a letter of intent that includes 
the following information:

o Descriptive title of the proposed research
o Name, address, and telephone number of the Principal Investigator
o Names of other key personnel
o Participating institutions
o Number and title of this RFA

Although a letter of intent is not required, is not binding, and does not 
enter into the review of a subsequent application, the information that it 
contains allows IC staff to estimate the potential review workload and plan 
the review.
 
The letter of intent is to be sent by the date listed at the beginning of 
this document.  The letter of intent should be sent to:

Melissa K. Welch-Ross, 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) 435-2307
FAX:  (301) 480-7773
E-mail:  rossm@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 
https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive 
format.  For further assistance contact GrantsInfo, Telephone (301) 710-0267, 
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 
https://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 https://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: 
https://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.
Acting Director, Division of Scientific Review
National Institute of Child Health and Human Development
6100 Executive Blvd., Room 5E03, 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 the participating ICs and agencies.  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 NICHD National Advisory Council.
 
REVIEW CRITERIA

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of your 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:  If the aims of the application are achieved, will the 
investigation contribute conceptual frameworks, methods, assessments, and/or 
products that have potential to advance both scientific knowledge and practice?

(2) APPROACH:
 
o Has the applicant provided a thorough description of the curriculum and 
approach to integration?  Is the potential merit of these for supporting 
early school readiness adequately justified on the basis of rigorous 
scientific evidence across relevant disciplines?
  
o Are there plans to identify and develop detailed conceptual models, 
research designs and methodological approaches most useful for identifying 
the components, processes, and conditions responsible for the short- and 
long-term effectiveness of the curriculum?
 
o Do plans include strategies for ascertaining and maintaining subjects from 
subgroups at risk for school failure?
 
o Are there an adequate justification and explanation of why the proposed 
planning activities are essential before beginning large-scale, multi-site 
evaluations that are responsive to this RFA?  To what degree will the 
specific activities proposed facilitate the conceptualization, design or 
implementation of studies that can address each overarching research question 
under Research Scope, and as appropriate, the central questions under 
Research Focus, above?

(3) INNOVATION:  Will the project that planning activities will support 
result in the development of new conceptual models, methodological 
approaches, measurements, assessments, technologies, or products?

(4) INVESTIGATOR:  Do the investigators have the appropriate training and 
expertise needed to conduct the large-scale, multi-site trials that planning 
activities will support?  Does the application include a thorough evaluation 
of the additional multidisciplinary content and methodological expertise 
required to design, execute, and evaluate the intervention, and a description 
of plans to secure such expertise during the planning period?

(5) ENVIRONMENT:
 
o How adequate and/or appropriate are the established sites and/or potential 
research sites to be secured during the planning period?  Have the applicants 
provided a thorough evaluation of barriers in the research environment that 
may affect the successful conduct of the research?  Have they described 
actions that will be taken to remove or reduce these barriers during the 
planning period?  Have they thoroughly described all other activities that 
will be undertaken to ensure that the environments contribute to the 
probability of success?
 
o Are approaches proposed for establishing relationships with research sites 
and implementers of the intervention both feasible and adequate for 
supporting all aspects of the project (e.g., subject recruitment, provision 
of adequate professional development, evaluation of implementation fidelity, 
assessment of outcomes, etc.)?

o Do the investigators plan to take advantage of unique features of the 
research environment and to secure all essential and useful collaborative 
arrangements?  Is there evidence of institutional support, to include support 
for establishing essential researcher-practitioner collaborations?
 
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 BUDGET:  The reasonableness of the proposed budget and the requested period 
of support in relation to the proposed research.

RECEIPT AND REVIEW SCHEDULE

Letter of Intent Receipt Date:    April 15, 2002
Application Receipt Date:         May 14, 2002
Peer Review Date:                 July 2002
Council Review:                   September 2002
Earliest Anticipated Start Date:  September 2002

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 
(https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); 
a complete copy of the updated Guidelines are available at 
https://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 
https://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 
https://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 
https://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 (NICHD) and 93.242 (NIMH) 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 
https://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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