ANIMAL MODELS OF ADOLESCENT DRUG ABUSE: INTEGRATIVE STUDIES OF BRAIN 
AND BEHAVIORAL DEVELOPMENT

RELEASE DATE:  October 31, 2003

RFA Number:  RFA-DA-04-011

Department of Health and Human Services (DHHS)

PARTICIPATING ORGANIZATION: 
National Institutes of Health (NIH) 
 (http://www.nih.gov)

COMPONENTS OF PARTICIPATING ORGANIZATION:
National Institute on Drug Abuse (NIDA) 
 (http://www.nida.nih.gov)

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.279

LETTER OF INTENT RECEIPT DATE:   February 17, 2004
APPLICATION RECEIPT DATE:        March 17, 2004

THIS REQUEST FOR APPLICATIONS (RFA) CONTAINS THE FOLLOWING INFORMATION:

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

There is a growing concern that adolescence marks a period 
characterized by enhanced vulnerability to the effects of drugs of 
abuse and the emergence of substance abuse disorders.  Recent studies 
in both animals and humans have demonstrated that a dramatic period in 
neural development coincides with the unique behavioral changes 
associated with adolescence.  These studies have given us a framework 
for understanding how the adolescent brain develops and how these 
alterations affect changes in behavior.  The National Institute on Drug 
Abuse (NIDA) is interested in determining: i) whether, and, if so, how 
change in the adolescent brain is associated with increased drug 
taking, and ii) how this dynamic substrate might be altered by drugs of 
abuse.  NIDA seeks to stimulate research that uses an integration of 
neurobiological and behavioral approaches to study adolescent brain 
development.  Thus applicants are expected to use animal models and an 
integrated approach to focus on the development of regions of the brain 
that are:
i) involved in drug-taking behavior, and/or ii) altered by acute or 
chronic exposure to drugs of abuse.  The goal of this RFA is to promote 
the advancement of innovative projects that incorporate 
multidisciplinary approaches to understand how physical transformations 
in the adolescent brain are related to the behavioral changes 
associated with drug abuse.  Some of the physical changes that are of 
interest include structural and functional changes in neurons and glia, 
and alterations in brain circuitry.  Some of the behavioral changes 
that are of interest include: learning, memory, risk taking, cognitive 
function, impulsivity, motivation and emotion.  The results of these 
studies should provide novel insight into the causes and effects of 
adolescent drug use. 
         
RESEARCH OBJECTIVES

Background

Adolescence is marked by the physical changes that occur during 
puberty, but the changes in behavior typically associated with this 
developmental period occur over a longer and less definitive period.  
These behavioral changes are poorly understood, but they can have 
dramatic effects on developmental trajectories and outcomes.  Many 
forms of risk taking and sensation seeking behaviors (including drug 
taking) begin during adolescence, and these behaviors can lead to a 
multitude of health-related problems, including increased rates of 
automobile accidents, suicide, drug abuse and exposure to HIV and 
hepatitis C.  Additionally, adolescent drug taking could potentially 
alter subsequent brain maturation, leading to changes in adult 
behaviors.

Until recently, brain development was thought to be largely complete 
after the first few years of childhood.  Thus, animal models 
(especially those using rodents and nonhuman primates) relied 
extensively on studies of mature organisms to understand basic 
neurobiological processes and behavioral phenomena.  As such, 
evaluation of the possible causes and consequences of substance abuse 
in younger, and perhaps more vulnerable, populations have been guided 
by the assumption that the adolescent brain is no different from that 
of the adult.  However, recent studies in both humans and animals have 
demonstrated that the brain continues to develop during adolescence and 
that this period of neurodevelopment is characterized by dramatic 
changes in brain growth and connectivity.  These structural changes 
coincide with dramatic shifts in a variety of behavioral and cognitive 
processes.  A complex interplay of genetic and environmental variables 
is clearly involved in adolescent development.  However, our 
understanding of the relationship between these factors is changing, 
primarily due to the recent research indicating that adolescence is a 
unique developmental period.

Some of the unique aspects of adolescent brain structure and function 
are becoming clear.  Human imaging studies have shown that a robust 
amount of brain growth occurs during the early teen years (in the form 
of axonal branching), and that this period is followed by a dramatic 
phase of pruning.  These changes occur in many regions of the brain 
(including the cortex, basal ganglia, and cerebellum) but they do not 
occur simultaneously: different brain regions develop during different 
phases.  Coincident with this growth, many important regions of the 
brain (e.g. the corpus callosum and the cerebellum) become better 
myelinated, again with distinct kinetics.  Thus, a number of circuits 
in the adolescent brain are established and refined in a complex and 
dynamic manner.

Similar changes are observed in a variety of animals.  Studies using a 
number of both mammalian and non-mammalian models have identified 
adolescent developmental periods, and this work has provided a 
foundation for using many animal species to study this process.  As in 
human adolescents, these brain changes are associated with changes in 
complex social behaviors.  From this work, we are beginning to identify 
the conserved changes in brain structure and regulation that coincide 
with the unique patterns of emotion and cognition seen during 
adolescent development.  

The influence of these structural and functional changes has not been 
fully integrated into our understanding of the cognitive, social, and 
emotional processes that characterize human adolescent development.  
One limitation of human investigations is the inability to test many 
hypotheses concerning causation.  This limitation has led to a debate 
over the role of neurodevelopment in behavior.  For example, does 
exuberant axonal growth and pruning in the prefrontal cortex (PFC) 
permit more abstract cognitive processing, or do the neurological 
changes simply result from this cognitive maturation?

With respect to NIDA’s mission, there is a need to examine brain 
development during adolescence in the context of understanding the 
vulnerability to: i) acquire drug abuse behaviors, ii) escalate to 
uncontrollable use, iii) abstain from drug taking, and iv) relapse 
after addiction.  Furthermore, this dynamic neurobiological substrate, 
the adolescent brain, may be differentially altered with exposure to 
drugs of abuse. To that end, understanding any and all of the 
consequences of this alteration on normal social, emotional and 
behavioral maturation is a critical public health issue. Two 
fundamental questions are: i) Do specific brain changes play a role in 
generating vulnerability to drug taking? and ii) Does drug exposure 
change subsequent brain development?  The tools to study this important 
phase of development are now at hand.

Objectives and Scope

Animal models provide an excellent opportunity to manipulate the adolescent 
brain.  Whereas some aspects of adolescent development are likely to be 
unique to humans (e.g., the degree of prefrontal cortex growth), many 
animals undergo similar processes in many, if not all, regions of the brain.  
Numerous studies demonstrate that adolescence is surprisingly conserved 
during mammalian development.  As such, many aspects of adolescent 
development can be studied in rodents and nonhuman primates.  Non-mammalian 
animal models with well-defined neurobiological and behavioral transitions 
are also likely to generate important and unique insights.  The 
neurobiological, molecular, and genetic methods that have been used to 
uncover animal brain development provide us with powerful tools to 
understand how adolescent neurodevelopment is linked causally to changes in 
behavior.  Given the evolutionary conservation of many of these processes, 
this information should generate insight into understanding human adolescent 
development.

NIDA seeks to promote relevant animal research integrating the use of basic 
neurobiology with behavioral studies.  The goals are to: i) establish 
neurobiological models for understanding the causes and consequences of 
adolescent behavior associated with drug taking, and ii) identify 
neurobiological correlates of behaviors associated with, or produced by, 
drugs of abuse.

The best approaches will be those that illuminate the causes and 
consequences of changes in adolescent brain development, and provide models 
for understanding behavioral vulnerabilities to, and effects of, drugs of 
abuse.  Two critical themes in this area of investigation should be: i) 
“which events are causal?” and ii) “to what extent are these influences on 
the behavior driven by internal (e.g., molecular mechanisms, genetics, or 
neurotransmitter system interactions) or external (e.g. environmental, 
rearing, social, context) factors?”  Emphasis should be placed on 
understanding the relationship between changes in behavior and changes in 
brain chemistry and architecture.  

Some fundamental areas of interest representing a merger of 
neurobiological and behavioral approaches are listed below (these are 
provided as examples and this list is not intended to cover the full 
range of projects of interest):

o Understand the temporal and spatial changes in neuroanatomy associated 
with adolescent maturation, as well as the behavioral consequences of these 
changes.  Particularly important changes include alterations in dendritic 
growth and branching in the prefrontal cortex (as well as other cortical 
areas), amygdala basal ganglia, and cerebellum.  The changes include, but 
are not limited to, specific changes in axonal branching, pruning and 
myelination.  Both histological and molecular gene expression studies will 
be needed to define these changes.  One key area of interest is to: i) 
determine how and when distinct regions of the brain associated with 
cognitive processes (e.g. inhibition) and subcortical motivational circuits 
become functionally connected, and ii) link key developmental changes in 
behavior with these events.  These changes could be studied using naïve 
animals, or animals treated with specific drugs of abuse.

o Define the relationship between anatomical and behavioral changes with 
variations in hormone levels. The interplay between the 
hypothalamus/pituitary/adrenal (HPA) axis and the developing brain is of 
particular interest.  Studies comparing and contrasting gender differences 
are encouraged in these and all other studies.

o Identify the effects of environmental, behavioral and contextual 
influences on neurodevelopmental processes.  In particular, NIDA is 
interested in determining if arousal, emotion and stress alter aspects of 
neural development that lead to increases in drug abuse or addiction.  Such 
studies could identify the neurological substrates for drug-seeking 
behaviors that affect the central processes of learning, memory, cognition, 
and/or motivation. 

o Analyze changes in neurogenesis and apoptosis that occur during 
adolescence, and identify the behavioral consequences of these changes 
(especially those that have implications for drug taking).  Determination of 
the role of drug use in altering these processes is encouraged, but not 
required.  Identification of any unique aspects of adolescent neurogenesis 
or apoptosis is of particular importance.

o Characterize the neurobiological effects of drug exposure during 
adolescence on the development of behaviors, emotions and cognitions that 
have been demonstrated to be important for understanding drug abuse and 
addiction.

o Compare the behavioral and neurobiological features of drug taking (i.e., 
initiation, maintenance, escalation, extinction, and relapse) in adolescent 
and adult animals. One important question is: how do chronic 
neuroadaptations of dependence, tolerance and sensitization differ between 
adolescent and adult animals? Furthermore, research could determine: i) how 
features of drug exposure (e.g., rate, schedules, context, etc.) or “drug 
history” affects the development of escalated drug intake, and ii) if the 
course of behavioral changes in vulnerability is different in adolescent and 
adult animals.  Related and integrated neurobiological substrate questions 
could target events at the cellular or molecular level. Those that have been 
demonstrated to be significant for important transitions in animal models of 
drug abuse behavior with adult animals could be used to verify and compare 
their significance in adolescent models of drug abuse.

o Identify critical periods during adolescent brain development for drug 
effects on cognitive, emotional or social behaviors.  These periods should 
be linked to changes in rates of acquisition and continuation of drug 
taking.  These behavioral changes should be tied to specific neurological 
changes during these critical periods.

o Examine the behavioral consequences of neuroadaptations to repeated drug 
administration in adolescent animals.  Potential questions include: “Are 
these neuroadapatations and the ensuing behavioral changes different from 
those that have been characterized in adults?” and “What are the types of 
neuroadaptations that lead to rapid progression of excessive, uncontrollable 
intake?”  Behavioral changes of interest include those indicating shifting 
central motivational processes, and responses to “natural” rewards, 
alterations in species-specific behavioral patterns, narrowing of behavioral 
repertoire, and changes in drug responsivity or sensitivity.

Some of the tools available to answer these questions include the 
following (these are provided as examples and this list is not intended 
to cover the full range of projects of interest):

o Pharmacological tools to probe the neurotransmitter substrates of 
behavior, motivation and cognition, as well as to assess drug responsivity 
or sensitivity.

o Animal behavioral models of motivation for drug and natural rewards, 
(including, but not limited to, i.v. drug self-administration) and 
conditioned place preference.  Especially encouraged is the use of choice 
procedures that provide alternative reinforcers or behaviors, and paradigms 
that allow for the development of dynamic behavioral typographies (e.g., 
sensitization, escalation, changing behavioral repertoires, etc.). 

o Genetic tools to determine the role of individual gene products in 
directing adolescent development and behavior.  While this work is perhaps 
most obviously performed using mice (i.e., mutants and transgenics), recent 
advances such as RNAi should allow researchers using a variety of animal 
models to understand the roles of individual gene products in particular 
brain regions.

o Approaches and candidates adapted from embryonic and early perinatal 
research. Such approaches have defined a variety of candidate molecules that 
regulate earlier neural development (e.g. the Wnt, BMP, GDNF, and FGF 
ligands). Recent research suggests that these molecules are also likely to 
function during adolescence.  As such, they are prime candidates to begin to 
understand the molecular basis of adolescent brain development.

o Comparative approaches that exploit species-specific differences in life 
histories and behavioral development during the adolescent period.  For 
example, species differences or specialization in social interaction, pair-
bonding and mating, territoriality, aggression, and communication behaviors 
may be useful for identifying the neurobiological basis of behaviors that 
are relevant for understanding the development of drug abuse and addiction.

MECHANISMS OF SUPPORT

This RFA will use the NIH research project (R01) and the 
exploratory/development (R21) award mechanisms 
(http://grants.nih.gov/grants/guide/pa-files/PA-03-107.html).  As an 
applicant you will be solely responsible for planning, directing, and 
executing the proposed project.  This RFA is a one-time solicitation.  
Future unsolicited, competing-continuation applications based on this 
project will compete with all investigator-initiated applications and 
will be reviewed according to the customary peer review procedures.  
The anticipated award date is September 30, 2004.  Applications that 
are not funded in the competition described in this RFA may be 
resubmitted as NEW investigator-initiated applications using the 
standard receipt dates for NEW applications described in the 
instructions to the PHS 398 application.

This RFA uses just-in-time concepts.  It also uses the modular 
budgeting as well as the non-modular budgeting formats (see 
http://grants.nih.gov/grants/funding/modular/modular.htm).  
Specifically, if you are submitting an application with direct costs in 
each year of $250,000 or less, use the modular budget format.  
Otherwise follow the instructions for non-modular budget research grant 
applications.  This program does not require cost sharing as defined in 
the current NIH Grants Policy Statement at 
http://grants.nih.gov/grants/policy/nihgps_2001/part_i_1.htm.

FUNDS AVAILABLE 
 
NIDA intends to commit approximately $1.5 million in FY 2004 to fund 4-
8 new and/or competitive continuation grants in response to this RFA. 
An applicant may request for the R01 a project period of up to 5 years. 
For the R21, the project period is 2 years and up to $275,000 in direct 
costs for the two-year period.  Because the nature and scope of the 
proposed research will vary from application to application, it is 
anticipated that the size and duration of each award will also vary. 
Although the financial plans of NIDA provide support for this program, 
awards pursuant to this RFA are contingent upon the availability of 
funds and the receipt of a sufficient number of meritorious 
applications. At this time, it is not known if this RFA will be 
reissued.

ELIGIBLE INSTITUTIONS

You may submit (an) application(s) 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 institutions/organizations
o Faith-based or community-based organizations

INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS   

Any individual with the skills, knowledge, and resources necessary to 
carry out the proposed research is invited to work with their 
institution to develop an application for support.  Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for NIH programs.   

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:

Robert Riddle, Ph.D.
Genetics and Molecular Neurobiology Branch
Division of Neuroscience and Behavioral Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 4258, MSC 9555
Bethesda, MD 20892-9555
Telephone: (301) 443-6300
FAX: (301) 594-6043
Email: riddler@nida.nih.gov

o Direct your questions about peer review issues to:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 234, MSC 8401
Bethesda, Maryland  20892-8401
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@mail.nih.gov

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

Gary Fleming, J.D., M.A.
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 242, MSC 8403
Bethesda, MD  20892-8403
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  gf6s@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 NIDA 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:

Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 234, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@mail.nih.gov

SUBMITTING AN APPLICATION

Applications must be prepared using the PHS 398 research grant 
application instructions and forms (rev. 5/2001). Applications must 
have a DUN and Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number as the Universal Identifier when applying for Federal grants or 
cooperative agreements. The DUNS number can be obtained by calling 
(866) 705-5711 or through the web site at 
http://www.dunandbradstreet.com/. The DUNS number should be entered on 
line 11 of the face page of the PHS 398 form. The PHS 398 document is 
available at http://grants.nih.gov/grants/funding/phs398/phs398.html in 
an interactive format.  For further assistance contact GrantsInfo, 
Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in 
a modular grant format.  The modular grant format simplifies the 
preparation of the budget in these applications by limiting the level 
of budgetary detail.  Applicants request direct costs in $25,000 
modules.  Section C of the research grant application instructions for 
the PHS 398 (rev. 5/2001) at 
http://grants.nih.gov/grants/funding/phs398/phs398.html includes step-
by-step guidance for preparing modular grants.  Additional information 
on modular grants is available at 
http://grants.nih.gov/grants/funding/modular/modular.htm.

USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 
5/2001) application form must be affixed to the bottom of the face page 
of the application.  Type the RFA number on the label.  Failure to use 
this label could result in delayed processing of the application such 
that it may not reach the review committee in time for review.  In 
addition, the RFA title and number must be typed on line 2 of the face 
page of the application form and the YES box must be marked. The RFA 
label is also available at: 
http://grants.nih.gov/grants/funding/phs398/label-bk.pdf.
 
SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten 
original of the application, including the Checklist, and three signed, 
photocopies, in one package to:
 
Center For Scientific Review
National Institutes Of Health/DHHS
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD  20892-7710
Bethesda, MD  20817 (for express/courier service)
 
At the time of submission, two additional copies of the application and 
all copies of the appendix material must be sent to:

Director
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 234, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)

APPLICATION PROCESSING: Applications must be received on or before the 
application receipt date listed in the heading of this RFA.  If an 
application is received after that date, it will be returned to the 
applicant without review.

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and 
funding assignments within 8 weeks.
 
The Center for Scientific Review (CSR) will not accept any application 
in response to this RFA that is essentially the same as one currently 
pending initial review, unless the applicant withdraws the pending 
application.  However, when a previously unfounded application, 
originally submitted as an investigator-initiated application, is to be 
submitted in response to an RFA, it is to be prepared as a NEW 
application.  That is, the application for the RFA must not include an 
Introduction describing the changes and improvements made, and the text 
must not be marked to indicate the changes from the previous unfunded 
version of the application.  

PEER REVIEW PROCESS  
 
Upon receipt, applications will be reviewed for completeness by the CSR 
and responsiveness by NIDA.  Incomplete applications will not be 
reviewed.  If the application is not responsive to the RFA, NIH staff 
may contact the applicant to determine whether to return the 
application to the applicant or submit it for review in competition 
with unsolicited applications at the next appropriate NIH review cycle.
 
Applications that are complete and responsive to the RFA will be 
evaluated for scientific and technical merit by an appropriate peer 
review group convened by NIDA in accordance with the review criteria 
stated below.  As part of the initial merit review, all applications 
will:

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

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 evaluate the 
application in order to judge the likelihood that the proposed research 
will have a substantial impact on the pursuit of these goals.  The 
scientific review group will address and consider each of the following 
criteria in assigning the application's overall score, weighting them 
as appropriate for each application. 

o Significance 
o Approach 
o Innovation
o Investigator
o Environment
  
The application does not 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?  Does the study address an important 
problem consistent with the goals of this RFA?

(2) APPROACH:  Are the conceptual framework, design, methods, and 
analyses adequately developed, well-integrated, and appropriate to the 
aims of the project?  Does the applicant acknowledge potential problem 
areas and consider alternative tactics?

(3) INNOVATION: Does the project employ novel concepts, approaches or 
methods? Are the aims original and innovative?  Does the project 
challenge existing paradigms or develop new methodologies or 
technologies?

(4) INVESTIGATOR: Is the investigator appropriately trained and well-
suited to carry out this work?  Is the work proposed appropriate to the 
experience level of the principal investigator and other researchers 
(if any)?

(5) ENVIRONMENT: Does the scientific environment in which the work will 
be done contribute to the probability of success?  Do the proposed 
experiments take advantage of unique features of the scientific 
environment or employ useful collaborative arrangements?  Is there 
evidence of institutional support?

ADDITIONAL REVIEW CRITERIA:  In addition to the above criteria, the 
following item will be considered in the determination of scientific 
merit and the priority score:

CARE AND USE OF VERTEBRATE ANIMALS IN RESEARCH: If vertebrate animals 
are to be used in the project, the five items described under Section f 
of the PHS 398 research grant application instructions (rev. 5/2001) 
will be assessed.  

ADDITIONAL REVIEW CONSIDERATIONS

Sharing Research Data 

Applicants requesting more than $500,000 in direct costs in any year of 
the proposed research must include a data sharing plan in their 
application. The reasonableness of the data sharing plan or the 
rationale for not sharing research data will be assessed by the 
reviewers. However, reviewers will not factor the proposed data sharing 
plan into the determination of scientific merit or priority score.  
(See 
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm.)

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:     February 17, 2004 
Application Receipt Date:          March 17, 2004
Peer Review Date:                  June/July 2004
Council Review:                    September 2004
Earliest Anticipated Start Date:   September 30, 2004

AWARD CRITERIA

Award criteria that will be used to make award decisions include:

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

SHARING RESEARCH DATA: Starting with the October 1, 2003 receipt date, 
investigators submitting an NIH application seeking more than $500,000 
or more in direct costs in any single year are expected to include a 
plan for data sharing or state why this is not possible. 
http://grants.nih.gov/grants/policy/data_sharing. Investigators should 
seek guidance from their institutions, on issues related to 
institutional policies, local IRB rules, as well as local, state and 
Federal laws and regulations, including the Privacy Rule. Reviewers 
will consider the data sharing plan but will not factor the plan into 
the determination of the scientific merit or the priority score.

HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of 
research on hESCs can be found at 
http://stemcells.nih.gov/index.asp and at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html.  
Only research using hESC lines that are registered in the NIH Human 
Embryonic Stem Cell Registry will be eligible for Federal funding (see 
http://escr.nih.gov).   It is the responsibility of the applicant to 
provide, in the project description and elsewhere in the application as 
appropriate, the official NIH identifier(s) for the hESC line(s)to be 
used in the proposed research.  Applications that do not provide this 
information will be returned without review. 

PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: 
The Office of Management and Budget (OMB) Circular A-110 has been 
revised to provide public access to research data through the Freedom 
of Information Act (FOIA) under some circumstances.  Data that are (1) 
first produced in a project that is supported in whole or in part with 
Federal funds and (2) cited publicly and officially by a Federal agency 
in support of an action that has the force and effect of law (i.e., a 
regulation) may be accessed through FOIA.  It is important for 
applicants to understand the basic scope of this amendment.  NIH has 
provided guidance at 
http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm.

Applicants may wish to place data collected under this PA 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.

STANDARDS FOR PRIVACY OF INDIVIDUALLY IDENTIFIABLE HEALTH INFORMATION:  
The Department of Health and Human Services (DHHS) issued final 
modification to the “Standards for Privacy of Individually Identifiable 
Health Information”, the “Privacy Rule,” on August 14, 2002.  The 
Privacy Rule is a federal regulation under the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996 that governs the 
protection of individually identifiable health information, and is 
administered and enforced by the DHHS Office for Civil Rights (OCR). 
Those who must comply with the Privacy Rule (classified under the Rule 
as “covered entities”) must do so by April 14, 2003 (with the exception 
of small health plans which have an extra year to comply).  

Decisions about applicability and implementation of the Privacy Rule 
reside with the researcher and his/her institution. The OCR website 
(http://www.hhs.gov/ocr/) provides information on the Privacy Rule, 
including a complete Regulation Text and a set of decision tools on “Am 
I a covered entity?”  Information on the impact of the HIPAA Privacy 
Rule on NIH processes involving the review, funding, and progress 
monitoring of grants, cooperative agreements, and research contracts 
can be found at 
http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

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 at http://www.cfda.gov/ and is not subject 
to the intergovernmental review requirements of Executive Order 12372 
or Health Systems Agency review.  Awards are made under the 
authorization of Sections 301 and 405 of the Public Health Service Act 
as amended (42 USC 241 and 284 and under Federal Regulations 42 CFR 52 
and 45 CFR Parts 74 and 92.  All awards are subject to the terms and 
conditions, cost principles, and other considerations described in the 
NIH Grants Policy Statement.  The NIH Grants Policy Statement can be 
found at http://grants.nih.gov/grants/policy/policy.htm.

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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