This Program Announcement expires on June 1, 2004, unless reissued.

BASIC AND APPLIED RESEARCH RELATED TO ADHD

Release Date:  April 24, 2001

PA NUMBER:  PA-01-083

National Institute of Mental Health
 (http://www.nimh.nih.gov)
National Institute on Alcohol Abuse and Alcoholism
 (http://www.niaaa.nih.gov/)
National Institute on Drug Abuse
 (http://www.nida.nih.gov/)
National Institute of Environmental Health Sciences
 (http://www.niehs.nih.gov/)

THIS PA USES "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS.  THIS PA INCLUDES 
DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED 
WHEN PREPARING AN APPLICATION IN RESPONSE TO THIS PA.

PURPOSE

Attention-deficit/Hyperactivity Disorder (ADHD) is a commonly diagnosed 
behavioral disorder of childhood.  Although some ADHD symptoms decrease with 
age, longitudinal studies find varying rates (10-60 percent) of persistent 
disabling ADHD symptoms into adolescence and adulthood.  Individuals 
diagnosed with ADHD can experience difficulties across multiple settings 
(home, school, peers) and can face long-term adverse effects on academic 
performance, occupational success, and social-emotional development that have 
a profound influence on individuals, families, schools, and society.  Despite 
progress in the assessment, diagnosis, and treatment of ADHD, there are many 
areas in which our knowledge may be expanded.  

Through this Program Announcement (PA) the participating institutes seek to 
encourage investigator-initiated research to enhance the scientific 
understanding of underlying mechanisms and risk processes related to ADHD and 
their implication for the development of effective interventions.  Major 
areas of research interest are:  (1) basic behavioral and neuroscience 
research in dimensions of attention, inhibitory control, emotion and other 
executive functions relevant to the etiologies, nosology, identification, 
prevention and/or treatment of ADHD; (2) basic or applied research on 
etiologies, risk factors, diagnosis, treatment and/or prevention of ADHD; and 
(3) research on the development of new interventions for use with individuals 
diagnosed with ADHD and their families.

This announcement encourages research involving collaboration between basic 
scientists and clinical researchers in the study of related dimensions of 
cognitive and emotional functioning.  During the 1998 NIH Consensus 
Development Conference on ADHD, evidence was presented indicating wide 
variations in clinical and research approaches for identifying, diagnosing 
and treating ADHD.  This variation reflects in part the absence of a 
theoretical consensus of underlying mechanisms involved in ADHD.  
Collaborative interdisciplinary research is needed to facilitate the 
expansion and translation of basic behavioral and neuroscience research that 
may improve the prevention, identification, diagnosis and treatment of ADHD.  
Similarly, communication of clinical findings is critical for identifying new 
questions to be addressed by basic research and to assist in interpreting 
findings.  It is believed that increased collaboration between basic and 
clinical scientists will enhance our understanding of the causal mechanisms 
underlying ADHD and subsequently improve our classification of the disorder 
and interventions.   

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 PA, Basic and Applied 
Research Related to ADHD, is related to the priority area of mental health 
and mental disorders.  Potential applicants may obtain a copy of "Healthy 
People 2010" at http://www.health.gov/healthypeople/.  

ELIGIBILITY REQUIREMENTS

Applications may be submitted by domestic and foreign, for-profit and non-
profit organizations, public and private, such as universities, colleges, 
hospitals, laboratories, units of State and local governments, and eligible 
agencies of the Federal government.  Racial/ethnic minority individuals, 
women, and persons with disabilities are encouraged to apply as principal 
investigators.

MECHANISM OF SUPPORT

This PA will use the National Institutes of Health (NIH) Research Project 
Grant (R01) award mechanism.  The Research Project Grant (R01) provides up to 
5 years of funding that is commensurate with the science proposed.  The total 
project period for an application submitted in response to this PA may not 
exceed 5 years. Responsibility for the planning, direction, and execution of 
the proposed project will be solely that of the applicant.  

Specific application instructions have been modified to reflect “MODULAR 
GRANT” and “JUST-IN-TIME” streamlining efforts being examined by the NIH.  
Complete and detailed information about modular grant applications can be 
found at:  http://grants.nih.gov/grants/funding/modular/modular.htm.

Applicants are encouraged to consult the Program Contact in the relevant 
institute listed under INQUIRIES for information on other research and career 
development grant mechanisms that are applicable to ADHD.

RESEARCH OBJECTIVES

Background

It is estimated that between 3-5 percent of elementary school-aged children 
meet diagnostic criteria for ADHD.  Core symptoms of ADHD include 
developmentally inappropriate levels of inattention, concentration 
difficulties, hyperactivity, distractibility, and impulsivity.  Individuals 
diagnosed with ADHD sometimes experience pronounced difficulties and 
impairment resulting from the disorder across multiple settings (home, 
school, and with peers).  For instance, children with ADHD are often rejected 
by peers, experience academic failure, and may engage in a broad array of 
disruptive behaviors.  Children diagnosed with ADHD followed into adulthood 
often have high levels of academic failure, poor work histories, poor social 
interactions and low self-esteem.  Although approximately 50 percent of 
children diagnosed with ADHD no longer meet diagnostic criteria for the 
disorder in adolescence, the persistent disorder in others often increases 
their risk for accidental injury, antisocial behavior and/or violence, poor 
school outcomes, and contact with the justice system.  More research is 
needed on the clinical, behavioral and cognitive trajectories of ADHD from 
childhood to adolescence and adulthood.  The high degree of restlessness, 
impulsivity, inattention, and oppositional behavior demonstrated by children 
diagnosed with ADHD is often associated with increased rates of parental 
frustration and marital discord.  Given the degree of impairment noted among 
individuals diagnosed with ADHD and the challenges it poses for families, the 
disorder is often considered a costly public health problem.  

The fourth edition of the Diagnostic and Statistical Manual for Mental 
Disorders (DSM-IV) describes three different subtypes of ADHD:  primarily 
hyperactive/impulsive, primarily inattentive, and a combined subtype.  
Prevalence estimates of the various ADHD subtypes are complicated by 
different methodological approaches.  Community-based samples are typically 
composed of an increased number of ADHD inattentive subtypes (1 in 10), while 
clinic-based samples find predominantly combined type ADHD diagnoses.  There 
is also increasing evidence that the nature of ADHD symptoms changes over 
time and development.  Hyperactive-impulsive symptoms appear to decrease with 
age, whereas inattentive symptoms show more stability.  Consequently, 
preschool children diagnosed with ADHD appear to more frequently meet 
diagnostic criteria for the Hyperactive/Impulsive subtype than older 
children, adolescents and adults.  In addition, different functional 
impairments appear to be related to the different ADHD subtypes across 
development.  For instance, conduct problems and/or substance abuse in 
adolescence seems more related to the presence of hyperactive/impulsive 
symptoms than inattention.  Despite the distribution of ADHD characteristics 
across the population, the majority of research on ADHD continues to center 
around school-aged males with a combined type diagnosis.  Consequently, there 
is a continued need to better understand the presentation of ADHD and its 
comorbid disorders across the life span (particularly preschool children, 
adolescents and adults), in females, and the ADHD Inattentive and 
Hyperactive/Impulsive subtypes.

ADHD symptoms rarely present themselves in isolation.  It is estimated that 
40-90 percent of children with ADHD present with comorbid aggression or 
conduct problems, 25 percent with comorbid anxiety disorders, and 15-20 
percent with comorbid mood disorders.  High rates of comorbid antisocial, 
mood and anxiety disorders have also been reported for adults with childhood-
onset ADHD.  The presentation of ADHD symptoms and comorbid conditions varies 
widely across gender, ethnicity, and age.  Evidence also suggests that this 
variation in subtype and comorbidity status may affect identification rates, 
differential treatment outcomes, and long-term prognosis.  Given the 
heterogeneity within the ADHD diagnosis, research is needed to determine 
whether ADHD is best thought of as a single disorder with subtypes or 
distinctly different disorders with unique etiologies.  

During the 1998 National Institute of Health (NIH) Consensus Development 
Conference on ADHD (see 
http://odp.od.nih.gov/consensus/cons/110/110_intro.htm), evidence was 
presented indicating wide variations in clinical and research approaches for 
identifying and diagnosing ADHD.  This variation reflects in part the paucity 
of normative information on the developmental progression of ADHD-relevant 
cognitive functions (e.g., attention regulation, inhibitory control) across 
age and gender.  The need for better normative data is supported by repeated 
findings that the dimensions of functioning relevant to ADHD exist along a 
continuum with blurred boundaries between “normal” and “abnormal.”  Approach 
differences in the identification of ADHD likely also stem from the absence 
of a theoretical consensus of underlying mechanisms specific to ADHD and the 
use of relatively subjective assessment tools.  Prevention efforts continue 
to be minimal in part due to the undefined pathways to ADHD symptom 
development.  

Various theories of ADHD etiology are currently being investigated.  Genetics 
research has indicated a familial aggregation and heritability associated 
with ADHD symptoms.  Geneticists have further identified a relationship 
between the diagnosis of ADHD in some individuals and the dopamine 
transporter (DAT) and/or D4 dopamine receptor (DRD4) genes.  Cognitive 
neuroscience research indicates a central nervous system basis for ADHD 
including a possible dopamine deficit.  Research on prenatal development 
suggests that ADHD symptom etiology may in some cases be related to alcohol 
or toxin exposure (e.g., lead) or episodes of oxygen deprivation for the 
fetus; however, further research is needed to investigate the specific impact 
of these factors on cognitive development among children with hyperactive, 
impulsive or inattentive symptoms.  Moreover, it may be the case that some 
percentage of children with ADHD-like symptoms respond favorably to diet 
alterations.  Clearly, unique combinations of environment and genetics 
contribute to the incidence and presentation of ADHD.  Genetic factors might 
also impact interventions.  These various and often complimentary etiologic 
theories of ADHD have implications for which interventions will be most 
successful for different individuals.  Research has indicated that one size 
does not fit all with regard to ADHD treatment.  Consequently, there is a 
great need for scientists to translate basic science findings to applications 
for ADHD etiology, differential diagnosis, and implications for targeted 
prevention and intervention.

Randomized clinical trials have been conducted that established the efficacy 
of stimulants for ameliorating some symptoms of ADHD and associated 
aggressiveness.  These studies have further indicated that stimulants are 
generally more effective than psychosocial therapies in treating these 
symptoms; however, results indicate inconsistent post-treatment improvements 
in functional impairments.  Compared to treatment studies with child 
populations, fewer studies examine effects of medication on adults with ADHD; 
yet preliminary controlled studies also find positive responses to both 
stimulants and nonstimulants.  Initial findings of the NIMH-sponsored Multi-
Modal Treatment Study of Children with ADHD (MTA) (see Archives of General 
Psychiatry, December 1999) suggest that the combination of medication 
management and behavioral intervention may have a slightly greater impact on 
positive functional outcomes (e.g., reading achievement, parent/child 
relations) than medication alone.  Furthermore, the MTA provides preliminary 
evidence that children with ADHD and various comorbid conditions may respond 
differentially to treatment modalities.  For instance, children with ADHD and 
comorbid anxiety may be less responsive to stimulant medications and more 
receptive to behavioral interventions.  These findings suggest the importance 
of matching children and families to treatments to which they will be most 
responsive; however, there is still relatively little information to guide 
treatment.  Much work continues to be needed to develop treatments that 
address specific long-term functional impairments and comorbid conditions.  

Many of the outstanding questions related to ADHD would benefit from the 
collaborative work of basic behavioral or neuroscience researchers with 
clinical scientists who specialize in ADHD.  The participating institutes 
hope to stimulate and encourage these interdisciplinary research efforts.  
Examples of potential collaborations could include, but are not limited to 
the following:

o  Experts in functional imaging with cognitive scientists whose expertise 
lies in the development of cognitive tasks

o  Psychopharmacologists collaborating with neuroscientists to identify 
neural mediators responsible for therapeutic effects of medications used to 
treat ADHD

o  Developmental psychologists collaborating with basic behavioral and 
neuroscientists to study emotion regulation, inhibitory control and/or 
attention regulation across the life span

o  Behavioral and molecular geneticists collaborating with attentional 
experts who could identify more objective measures of attention to supplement 
rating scales

o  Interventionists collaborating with basic social or behavioral scientists 
who have expertise in domains such as family functioning, peer relations, 
information processing or cognitive performance to develop interventions as 
well as measures of treatment process and outcome

The following 4 sections expand upon areas of need regarding basic and 
applied research related to ADHD etiology, identification, diagnosis and 
intervention.  Sample research topic areas are not exhaustive, but are meant 
to provide examples of research from which researchers can generate further 
questions.  

Basic Research Related to ADHD

Research on the biological, cognitive, and/or genetic processes related to 
ADHD deficits (e.g., selective and/or sustained attention, inhibitory 
control, information processing, memory, vigilance, motor control, etc.) and 
their development among ADHD and non-ADHD children, adolescents, and/or 
adults is needed to facilitate and clarify ADHD nosology and taxonomy.  It is 
hoped that research in this area will have implications for the understanding 
of ADHD subtype clusters, heterogeneous presentation across gender and age, 
comorbid conditions and functional impairments that co-occur with ADHD.  It 
is also hoped that this research will impact the prevention and/or 
intervention strategies for this disorder.  Listed below are examples of 
research topics.  This list is illustrative, not exhaustive; it is expected 
that researchers who respond to this PA will identify additional important 
research topics.

o  Studies of the normative development of attention, inhibitory control, 
motivation and other executive functions across the life span

o  Studies that aim to understand the genetic, physiological, cognitive or 
neurobiological mechanisms underlying the cognitive deficits and behavioral 
symptoms associated with ADHD, its subtypes and/or co-occurring behavior 
problems

o  Application of imaging studies to understand basic neural circuits 
underlying ADHD

o  Studies that attempt to standardize, validate, or gather normative data on 
laboratory measures of cognitive functioning for potential application to 
clinical ADHD or related populations

o  Research on complex cognitive factors and functioning associated with the 
clinical presentation of ADHD (e.g., motivation, performance decay, response 
variability) incorporating the potential changes in these factors over time 
and across situations in ADHD and non-ADHD samples

o  Development of animal models that incorporate the cognitive or behavioral 
deficits associated with ADHD and/or examine the role of medication within 
these animal models

o  Identification of ADHD clinical measures that may be modeled in animals to 
identify neural systems mediating those behaviors, effects of age, etc.

o  Neuroimaging studies of treatment naïve children with ADHD 

o  Studies of genetic epidemiology and ADHD

o  Basic and clinical research that links ADHD-related cognitive and 
motivational deficits to genotypes and/or behavioral phenotypes

o  Development of a cognitive test battery to diagnose core symptoms of ADHD

Investigators who wish to submit applications involving structural magnetic 
resonance imaging (MRI) or magnetic resonance spectroscopy (MRS) may wish to 
familiarize themselves with the NIH MRI Study of Normal Brain Development, 
which will establish a normative magnetic resonance (MR) database for ages 0-
18.  Interested parties may contact Dr. Judith Rumsey at:  jrumsey@box-j.nih.gov 
or 301-443-1692.

Etiologies, Risk Factors, and Prevention 

Given the heterogeneous nature of ADHD, research on the differential risk 
factors and nosology of ADHD subtypes and comorbid conditions is very 
important.  There is a need to define risk and protective factors for the 
identification of ADHD as well as the developmental processes (behavioral, 
biobehavioral, social, emotional, and cognitive) that lead to the disorder.  
An understanding of these factors and developmental course of ADHD could then 
be translated into new prevention, early intervention and treatment 
strategies.  Listed below are examples of research projects that could 
advance scientific knowledge on the etiologies, risk factors, prevention and 
treatment of ADHD.  The list is not exhaustive, and it is expected that those 
who respond to the announcement may identify additional important research 
topics.  Studies in these areas can include, but are not limited to:

o  Research that links basic attentional, motivational or emotional processes 
to risk assessments and ADHD nosology within a developmental model 

o  Research on the heterogeneity in the disorder to determine whether ADHD is 
best thought of as a single disorder with subtypes or distinctly different 
disorders (identification of genetic, behavioral, and neurochemical markers) 

o  Behavioral and neuroscience research that studies children with ADHD 
across time and in multiple situations, including those which tend to 
normalize their symptomatic behavior (e.g., highly stimulating and/or novel 
activities)

o  Taxonomy research to move the diagnosis of ADHD from a subjective 
criteria- based approach to one based on more objective markers 

o  Research that investigates the course, diagnostic characteristics and 
long-term prognosis of ADHD within female populations, preschool children, 
adolescents and adults

o  Research that examines the influence of race, culture and socio-economic 
status on the etiology, longitudinal course and symptom presentation of ADHD

o  Epidemiological research which attempts to link early risk factors and/or 
developmental history (e.g., exposure to alcohol prenatally or to 
environmental toxins) to specific cognitive deficits

o  Research that examines mediating and moderating variables in the 
trajectory from ADHD-symptom development to functional impairment (e.g., 
academic underachievement, accidental injury)

o  Research that investigates the influence of comorbid conditions and 
various subtype profiles on the identification, diagnosis, and course of ADHD 

o  Research to improve our knowledge about risk and protective factors within 
various contexts in order to develop new approaches for preventing the onset 
or exacerbation of ADHD

o  Research that relates work from early childhood developmental research in 
areas such as temperament, infancy behaviors, development of effortful 
control or emotion regulation to ADHD onset, course and prevention 

o  Research on the development of preventative interventions that build upon 
the body of literature surrounding risk factors and the early identification 
of specific deficits associated with ADHD 

Treatment Development

Numerous treatments have been designed for individuals diagnosed with ADHD; 
however, many of these interventions continue to have little impact on long-
term functional outcomes.  Furthermore, several treatments have been tested 
within narrowly defined populations, such as boys with a combined type 
diagnosis.  Consequently, the development of interventions that specifically 
consider treatment impact on age-appropriate functional outcomes (e.g., 
academic achievement, peer functioning, vocational success) as well as ADHD 
symptoms, is encouraged.  Interventions that target females diagnosed with 
ADHD, preschool children, adolescents and adults as well as individuals with 
co-occurring disorders are particularly underrepresented.  Treatment 
development includes the conceptualization, development, standardization, 
and/or testing (pilot testing, field studies, or small scale experiments) of 
a theory-driven, empirically based intervention approach.  Listed below are 
examples of research projects that could advance scientific knowledge on the 
treatment of ADHD.  The list is not exhaustive, and it is expected that those 
who respond to the announcement may identify additional important research 
topics.  Studies in these areas can include, but are not limited to:

o  Research on the development of innovative interventions for individuals 
diagnosed with ADHD derived from basic behavioral and/or neuroscience 
findings

o  Research that integrates new findings on the neurodevelopment of attention 
and behavior regulation into novel treatment approaches

o  Research to clarify which treatments are most effective in not only 
treating core ADHD and co-occurring symptoms, but also age-related functional 
impairments (e.g., academic achievement, vocational success)

o  Treatment development research that examines the influence of race, 
culture and socio-economic status on treatment response

o  Research that investigates the influence of comorbid conditions or 
diagnostic subtypes for predicting treatment process and outcome 

o  Research on the development of early intervention strategies for young 
children identified as having ADHD or at risk for the development of ADHD

o  Research on provider behavior and decision making as factors that not only 
influence client identification and treatment, but could also serve as 
potential targets for intervention

Researchers interested in developmental psychopharmacology should see a 
complementary announcement, Developmental Psychopharmacology, at:  
http://grants.nih.gov/grants/guide/pa-files/PA-00-114.html, which is aimed at 
understanding the mechanisms, both therapeutic and adverse, of long-term 
pharmacological treatment.

NIAAA will consider funding alcohol-relevant applications submitted in 
response to this PA.  For example, attention deficits are consistently 
identified in children with fetal alcohol syndrome (FAS) or alcohol-related 
neurodevelopmental disorder (ARND).  In addition, offspring of male 
alcoholics, who are at increased risk for alcohol problems as adults, also 
display more problems during childhood and adolescence, particularly problems 
and disorders of attention, anxiety, and conduct.  Insufficient research has 
been devoted to the underlying genetic, neurobiological and environmental 
factors that may influence the expression and severity of ADHD, or the 
response to treatment, in these populations.  More studies are needed on the 
impact of ADHD on cognitive and social functioning across the life span, 
particularly with respect to risk for alcohol abuse and/or alcoholism in 
adolescence and adulthood.  Many of the research topics listed above address 
issues that would advance scientific knowledge to improve prevention, 
diagnosis, and treatment of FAS and ARND, and elucidate the role of ADHD in 
the initiation of drinking and progression to alcohol use problems.

Of interest to NIDA is animal and human research that (a) examines the 
relationship between childhood ADHD, and/or the treatment of childhood ADHD, 
on subsequent vulnerability to drug abuse in adolescence or adulthood; (b) 
analyzes the adult co-morbidity for ADHD and drug abuse; (c) studies the 
influence of caregiver drug abuse on the etiology of ADHD; (d) addresses 
prenatal and/or perinatal exposure to drugs of abuse as potential etiological 
factors in ADHD; and (e) explores treatment responsivity in ADHD patients as 
a function of prior exposure to drugs of abuse.  Of particular interest in 
all of these areas are specific studies of cognitive and behavioral 
processes.

INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS 

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 biomedical and 
behavioral research projects involving human subjects, unless a clear and 
compelling rationale and justification are 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 research involving human subjects should read the 
UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects 
in Clinical Research,” published in the NIH Guide for Grants and Contracts on 
August 2, 2000 
(http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html); 
a complete copy of the updated Guidelines are available at:  
http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm.  The 
revisions relate to NIH defined Phase III clinical trials and require: a) all 
applications or proposals and/or protocols to 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) all 
investigators to report accrual, and to conduct and report analyses, as 
appropriate, by sex/gender and/or racial/ethnic group differences.

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS

It is the policy of NIH 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 was published in the NIH Guide for 
Grants and Contracts, March 6, 1998, and is available at the following URL 
address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html.

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

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 review the Internet sites.  Reviewers are cautioned that their anonymity 
may be compromised when they directly access an Internet site.

NIH GRANTS POLICY STATEMENT

The NIH Grants Policy Statement (NIHGPS) has been revised and reissued.  The 
provisions of the revised NIHGPS are effective for all funded NIH grants and 
cooperative agreements with budget periods beginning on or after March 1, 
2001.  The revised NIHGPS is available at:  
http://grants.nih.gov/grants/policy/nihgps_2001.

APPLICATION PROCEDURES

Applicants are strongly encouraged to contact the program contacts listed 
under INQUIRIES with any questions regarding their proposed project and the 
goals of this PA.

Applications are to be submitted on the grant application form PHS 398 (rev.
4/98) and will be accepted at the standard application deadlines as indicated
in the application kit.  Application kits are available at most institutional 
offices of sponsored research and from the Division of Extramural Outreach 
and Information Resources, National Institutes of Health, 6701 Rockledge 
Drive, MSC 7910, Bethesda, MD 20892-7910, telephone:  301-435-0714, Email: 
GrantsInfo@nih.gov.  Applications are also available on the World Wide Web 
at: http://grants.nih.gov/grants/forms.htm.

SPECIFIC APPLICATION INSTRUCTIONS FOR MODULAR GRANTS

The modular grant concept establishes specific modules in which direct costs 
may be requested as well as a maximum level for requested budgets.  Only 
limited budgetary information is required under this approach.  The 
just-in-time concept allows applicants to submit certain information only 
when there is a possibility for an award.  It is anticipated that these 
changes will reduce the administrative burden for the applicants, reviewers 
and Institute staff.  The research grant application form PHS 398 (rev. 4/98) 
is to be used in applying for these grants, with the modifications noted 
below.

BUDGET INSTRUCTIONS

Modular Grant applications will request direct costs in $25,000 modules, up 
to a total direct cost request of $250,000 per year.  Applications that 
request more than $250,000 direct costs in any year must follow the 
traditional PHS 398 application instructions.  The total direct costs must be 
requested in accordance with the program guidelines and the modifications 
made to the standard PHS 398 application instructions described below:

PHS 398

o  FACE PAGE: Items 7a and 7b should be completed, indicating direct costs 
(in $25,000 increments up to a maximum of $250,000) and total costs (modular 
total direct plus facilities and administrative (F&A) costs) for the initial 
budget period.  Items 8a and 8b should be completed indicating the direct and 
total costs for the entire proposed period of support.

o  DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD:  Do not complete Form Page 
4 of the PHS 398.  It is not required and will not be accepted with the 
application.

o  BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT:  Do not complete the 
categorical budget table on Form Page 5 of the PHS 398.  It is not required 
and will not be accepted with the application.

o  NARRATIVE BUDGET JUSTIFICATION:  Prepare a Modular Grant Budget Narrative 
page.  (See http://grants.nih.gov/grants/funding/modular/modular.htm for 
sample pages.)  At the top of the page, enter the total direct costs 
requested for each year.  This is not a Form page.

o  Under Personnel, list all project personnel, including their names, 
percent of effort, and roles on the project.  No individual salary 
information should be provided.  However, the applicant should use the NIH 
appropriation language salary cap and the NIH policy for graduate student 
compensation in developing the budget request.

For consortium/contractual costs, provide an estimate of total costs (direct 
plus facilities and administrative) for each year, each rounded to the 
nearest $1,000.  List the individuals/organizations with whom consortium or 
contractual arrangements have been made, the percent effort of all personnel, 
and the role on the project.  Indicate whether the collaborating institution 
is foreign or domestic.  The total cost for a consortium/contractual 
arrangement is included in the overall requested modular direct cost amount.  
Include the Letter of Intent to establish a consortium.

Provide an additional narrative budget justification for any variation in the 
number of modules requested.

o  BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by 
reviewers in the assessment of each individual's qualifications for a 
specific role in the proposed project, as well as to evaluate the overall 
qualifications of the research team.  A biographical sketch is required for 
all key personnel, following the instructions below.  No more than three 
pages may be used for each person.  A sample biographical sketch may be 
viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm

- Complete the educational block at the top of the form page;
- List position(s) and any honors;
- Provide information, including overall goals and responsibilities, on 
research projects ongoing or completed during the last 3 years; and,
- List selected peer-reviewed publications, with full citations.

o  CHECKLIST:  This page should be completed and submitted with the 
application.  If the F&A rate agreement has been established, indicate the 
type of agreement and the date.  All appropriate exclusions must be applied 
in the calculation of the F&A costs for the initial budget period and all 
future budget years.

o  The applicant should provide the name and phone number of the individual 
to contact concerning fiscal and administrative issues if additional 
information is necessary following the initial review.

Applicants planning to submit an investigator-initiated new (type 1), 
competing continuation (type 2), competing supplement, or any amended/revised 
version of the preceding grant application types requesting $500,000 or more 
in direct costs for any year are advised that he or she must contact the 
Institute program staff before submitting the application, i.e., as plans for 
the study are being developed.  Furthermore, the application must obtain 
agreement from the Institute staff that the Institute will accept the 
application for consideration for award.  Finally, the applicant must 
identify, in a cover letter sent with the application, the staff member and 
Institute who agreed to accept assignment of the application.

This policy requires an applicant to obtain agreement for acceptance of both 
any such application and any such subsequent amendment.  Refer to the NIH 
Guide for Grants and Contracts, March 20, 1998 at 
http://grants.nih.gov/grants/guide/notice-files/not98-030.html.

Any application subject to this policy that does not contain the required
information in a cover letter sent with the application will be returned to 
the applicant without review.

The title and number of the PA must be typed on line 2 of the face page of 
the application form and the YES box must be marked.

Submit a signed, typewritten original of the application, including the 
Checklist, and five 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)

REVIEW CONSIDERATIONS

Applications will be assigned on the basis of established PHS referral 
guidelines.  Applications will be evaluated for scientific and technical 
merit by an appropriate scientific review group convened by NIH in accordance 
with the standard NIH peer review procedures.  As part of the initial merit 
review, all applications will receive a written critique and undergo a 
process in which only those applications deemed to have the highest 
scientific merit, generally the top half of applications under review, will 
be discussed, assigned a priority score, and receive a second level review by 
the appropriate national advisory council or board.

Review Criteria 

The goals of NIH-supported research are to advance our understanding of 
biological systems, improve the control of disease, and enhance health.  In 
the written comments, reviewers will be asked to discuss the following 
aspects of the application in order to judge the likelihood that the proposed 
research will have a substantial impact on the pursuit of these goals.  Each 
of these criteria will be addressed and considered in assigning the overall 
score, weighting them as appropriate for each application.  Note that the 
application does not need to be strong in all categories to be judged likely 
to have major scientific impact and thus deserve a high priority score.  For 
example, an investigator may propose to carry out important work that by its 
nature is not innovative, but is essential to move a field forward.

(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?

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

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

o  Reasonableness of the proposed budget and duration in relation to the 
proposed research

o  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

AWARD CRITERIA

Applications will compete for available funds with all other recommended 
applications.  The following will be considered in making funding decisions:  
Quality of the proposed project as determined by peer review, availability of 
funds, and program priority.

INQUIRIES

Inquiries are encouraged.  The opportunity to clarify any issues or questions 
from potential applicants is welcome.  Potential applicants are encouraged to 
consult with the Program Staff listed below for information and guidance on 
other research and career development mechanisms that are applicable to ADHD. 

Direct inquiries regarding programmatic issues to:

Farris Tuma, Sc.D.
Developmental Psychopathology and Prevention Research Branch
Division of Mental Disorders, Behavioral Research and AIDS 
National Institute of Mental Health
6001 Executive Boulevard, Room 6200, MSC 9617 
Bethesda, MD 20892-9617 
Telephone:  (301) 443-5944 
Fax:  (301) 480-4415
Email:  ftuma@mail.nih.gov 

Beth-Anne Sieber, Ph.D.
Molecular and Cellular Neuroscience Research Branch
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7186, MSC 9641
Bethesda, MD  20892-9641
Telephone:  (301) 443-5288
Fax:  (301) 402-4740
Email:  sieberb@helix.nih.gov

Laurie Foudin, Ph.D.
Program Administrator
Biomedical Research Branch
Division of Basic Research
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 402, MSC 7003
Bethesda, MD 20892-7003
Telephone:  (301) 443-0912
Fax:  (301) 594-0673
Email:  Lfoudin@nih.gov

Cora Lee Wetherington, Ph.D.
Behavioral and Cognitive Sciences Research Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 4282, MSC 9555
Bethesda, MD 20892-9555
Telephone:  (301) 443-1263
Fax:  (301) 594-6043
Email:  wetherington@nih.gov

Annette Kirshner, Ph.D.
Organs and Systems Toxicology Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Box 12233 MD EC-23
Research Triangle Park, NC 27709
Telephone:  (919) 541-0488
Fax:  (919) 541-5064
Email: kirshner@niehs.nih.gov

Direct inquiries regarding fiscal matters to:

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
Email:  Diana_Trunnell@nih.gov

Judy Simons
Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism
6000 Executive Boulevard, Suite 504, MSC 7003
Bethesda, MD 20892-7003
Telephone:  (301) 443-2434
Fax:  (301) 443-3891
Email:  jsimons@willco.niaaa.nih.gov

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse
6001 Executive Boulevard, Room 3131, MSC 9541
Bethesda, MD  20892-9541
Telephone:  (301) 443-6710
Fax:  (301) 594-6849
Email: gf6s@nih.gov

Laura Williams-Boyd
Grants Management Branch
Division of Extramural Research and Training
National Institute of Environmental Health Sciences
Box 12233 MD EC-22
Research Triangle Park, NC 27709
Telephone:  (919) 541-7629
Fax:  (919) 541-2860
Email: willia27@niehs.nih.gov

AUTHORITY AND REGULATIONS

This program is described in the Catalog of Federal Domestic Assistance No. 
93.242 (NIMH), 93.273 (NIAAA), 93.279 (NIDA), and 93.114 (NIEHS).  Awards are 
made under authorization of the Public Health Service Act, Title IV, Part A 
(Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and 
administered under NIH grants policies and Federal Regulations 42 CFR 52 and 
45 CFR Part 74.  This program is not subject to the intergovernmental review 
requirements of Executive Order 12372 or Health Systems Agency review.

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

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	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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