EPIDEMIOLOGY OF DRUG ABUSE

RELEASE DATE:   May 3, 2004

PA NUMBER:  PA-04-100

December 8, 2006 - The R01 portion of this funding opportunity has been 
replaced by PA-07-118, which now uses the electronic SF424 (R&R) 
application for February 5, 2007 submission dates and beyond.

March 2, 2006 (NOT-OD-06-046) – Effective with the June 1, 2006 submission date, 
all R03, R21, R33 and R34 applications must be submitted through Grants.gov using 
the electronic SF424 (R&R) application. This announcement will stay active for 
only the May 1, 2006 AIDS and AIDS-related application submission date for these 
mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms 
expires on the date indicated below. Other mechanisms relating to this announcement 
will continue to be accepted using paper PHS 398 applications until the stated 
expiration date below, or transition to electronic application submission. 
Replacement R03 (PA-06-330) and R21 (PA-06-329) funding opportunity announcements 
have been issued for the submission date of June 1, 2006 and submission dates 
for AIDS and non-AIDS applications thereafter.

Expiration Date for R03 and R21 Non-AIDS Applications: March 2, 2006
Expiration Date for R03 and R21 AIDS and AIDS-Related Applications: May 2, 2006 
Expiration Date for R01 Non-AIDS Applications: November 2, 2006 
Expiration Date for R01 AIDS and AIDS-Related Applications: January 3, 2007

Department of Health and Human Services (DHHS)

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

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

CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER:  93.279

THIS PROGRAM ANNOUNCEMENT (PA) CONTAINS THE FOLLOWING INFORMATION

o Purpose of the PA
o Research Objectives
o Mechanisms of Support 
o Eligible Institutions
o Individuals Eligible to Become Principal Investigators
o Where to Send Inquiries
o Submitting an Application
o Supplementary Instructions
o Peer Review Process
o Review Criteria
o Award Criteria
o Required Federal Citations

PURPOSE OF THIS PA

This program announcement (PA) replaces PA-99-002, “Epidemiologic Research on 
Drug Abuse,” published in the NIH Guide, October 2, 1998; PA-99-113, “Drug 
Use and Related Adverse Behavioral and Social Consequences,” published in the 
NIH Guide, June 18, 1999; and PAR-99-168, “Research on the Origins and 
Pathways to Drug Abuse.”  This new PA encourages a broad range of 
epidemiologic research on drug use, abuse, and dependence.  It highlights new 
areas for research that emphasize the vital public health role of 
epidemiologic research in drug abuse.

The major goal of this PA is to stimulate innovative investigations that 
enhance our understanding of: (1) drug use patterns and trends within and 
across populations; (2) interplay of social interactions, social environment, 
structural context with individual behavioral characteristics and genetic 
vulnerability; (3) the phenotypic heterogeneity of drug abuse; (4) causal 
mechanisms leading to onset, maintenance, and remittance of drug abuse, as 
well as protective mechanisms that reduce the risk of drug abuse; and (5) 
drug abuse over the life course, including developmental processes that 
influence drug use trajectories and behavioral, health, and social 
consequences of drug abuse.  In addition, research is encouraged to develop 
methodologies to improve the accuracy, efficiency, scope, timeliness, and 
analytic yield of drug abuse epidemiologic data.  Because of the breadth of 
epidemiology research, applications are anticipated to reflect diverse and 
multidisciplinary putative approaches and multiple levels of causation.  To 
take advantage of the strength of specific research fields in an efficient 
manner, and to maximize the generalizability of findings, researchers are 
encouraged to develop and/or incorporate innovations in epidemiologic study 
design.  Such designs may include nesting of biological and/or basic 
research, contextual analysis, and contemporary longitudinal analyses.

RESEARCH OBJECTIVES

Background

Drug abuse epidemiologic research focuses on understanding the nature, 
extent, consequences, and etiology of drug abuse across individuals, 
families, age groups, gender, communities, and population groups.  
Epidemiologic research plays a critical public health role by providing an 
estimate of the magnitude, impact, and risk of drug abuse on a population, 
and by laying the foundation for developing strategies to prevent drug abuse, 
plan and evaluate drug abuse services, and suggest new areas for basic, 
clinical, and treatment research.

The natural history of drug abuse can be observed most validly in 
epidemiologic studies and the population-based approach provides specific 
advantages over research relying on samples of convenience, such as clinical 
samples, by reducing the potential for selection bias in observed 
associations while enhancing generalizability.  There are, however, 
limitations to epidemiologic research.  Large sample sizes can pose 
difficulties in terms of time and cost to obtain intensive and detailed 
measures, particularly over extended periods of time.  Also, the 
observational nature of much epidemiologic drug abuse research limits 
experimental control and manipulation of variables under study.  However, 
underutilized applications in epidemiologic study design, such as nested case 
control studies, enable integration of focused intensive measurement in the 
context of epidemiologic research.  It is also possible to draw 
epidemiologically informative samples, based on specific characteristics, for 
recruitment into laboratory-based research.  Although collaboration between 
laboratory-based and epidemiologic research is becoming more widespread in 
other areas of health research, it is less common in the field of drug abuse 
research.  This PA encourages innovative research that incorporates the 
strengths of epidemiologic and laboratory-based designs.

Recent advances in health science research have connected biological and 
genetic factors across the spectrum of diseases including drug abuse and 
addiction.  For diseases with a substantial environmental component, however, 
biology and genetics are not sufficient to explain or predict disease 
patterns.  In order to better understand the epidemiology of drug abuse and 
its consequences within and across populations, research is encouraged on the 
influence of social and cultural factors on the initiation and progression of 
drug use among population groups.  Novel conceptualization and measurement of 
social and cultural contexts within theoretically grounded research are 
important to the advancement of drug abuse research.  Increased understanding 
of how genetic, biological, social, and contextual phenomena interact to 
influence behavior will inform prevention and treatment for individuals at 
risk for drug abuse.

Crosscutting Issues

Research indicates that there are significant gender-specific differences in 
biological factors in drug abuse, antecedents and consequences of drug abuse, 
and responses to prevention and treatment.  Investigators should, wherever 
germane, include adequate numbers of both male and female subjects in their 
studies in order to make meaningful gender comparisons.  Researchers are also 
encouraged to design studies to explore gender differences in the nature and 
extent of drug-using behaviors, in the pathways and determinants of 
initiation, progression and maintenance of drug abuse, and the behavioral and 
social consequences of drug abuse.  For more information on research on this 
topic, see the Women, Gender Differences and Drug Abuse PA 
http://grants.nih.gov/grants/guide/pa-files/PA-03-139.html.

HIV/AIDS and drug abuse are frequently referred to as twin epidemics, and 
whenever possible, it is essential that epidemiologic studies address this 
interrelationship.  Investigators are encouraged to incorporate appropriate 
measures and analyses of factors critical to understanding the transmission 
of HIV/AIDS and other sexually transmitted diseases (STDs), Hepatitis (HCV 
and HCB), and Tuberculosis (TB), as well as related disparities across 
different population groups.  The aim is to promote integrated approaches to 
understanding and addressing interactions between individuals and 
environments that contribute to the continuum of problems related to drug 
abuse, including HIV/AIDS.  For more information on research on this topic, 
see http://hiv.drugabuse.gov and 
http://www.drugabuse.gov/MeetSum/HIVworkshop.html.

Research shows that minority groups, particularly Blacks and Hispanics, are 
in some instances less likely to use licit or illicit drugs, but that such 
groups tend to be over-represented among those who suffer from adverse 
health, behavioral, and social consequences related to drug use (e.g., 
HIV/AIDS, premature births, intentional and unintentional injuries, violence, 
crime, etc.).  Epidemiologic research is clearly needed to inform prevention 
and intervention strategies aimed at reducing and eliminating drug-related 
health disparities, as well as services research on access, utilization, and 
retention of racial and ethnic minority populations in drug abuse treatment.  
This announcement therefore encourages research that focuses on identifying 
risk factors and consequences that are unique to or more prevalent in 
subpopulations in socioeconomically disadvantaged (i.e., low education level, 
poverty) and medically underserved rural and urban communities.  For more on 
NIDA’s interest in this topic, see 
http://www.drugabuse.gov/StrategicPlan/HealthStratPlan.html.

Advances in the field of drug abuse epidemiology will require innovations in 
statistical, epidemiologic, sociologic, and genetic epidemiologic designs to 
meet challenges in the rapidly evolving drug abuse field.  This announcement 
encourages methodological innovations that address transitions in stages and 
trajectories of drug abuse, intergenerational transmission of drug abuse, and 
heterogeneous pathways to and consequences of drug abuse.  Especially 
encouraged are approaches that facilitate: (a) nested case-control and case-
cohort designs that efficiently combine the advantages of epidemiologic 
samples with more intensive laboratory-based and biological measures, (b) 
innovations in measurement such as real-time measures of drug abuse through 
the use of handheld devices, and (c) secondary analyses of existing 
epidemiologic data sets that contain high-quality information about drug 
abuse.  For more information on research using secondary analyses, 
particularly research on psychopathology vulnerability for drug abuse, see 
the Risk Factors for Psychopathology using Secondary Data Sets PA 
http://grants.nih.gov/grants/guide/pa-files/PA-03-044.html.

Major Program Areas

The epidemiologic drug abuse research program is further organized into major 
program areas that are described below.  It is important to note that the 
crosscutting issues of gender, HIV/AIDS, health disparities, and 
methodological innovations apply across all of these topics.  Examples of the 
types of research topics include, but are not limited to, the following:

o Emerging and current trends
o Social epidemiology of drug abuse
o Familial/genetic liability and phenotypic heterogeneity
o Drug abuse psychopathology: comorbidity and vulnerability 
o Human development in adolescence and adulthood
o Developmental consequences of drug abuse
o Social and behavioral consequences of street drugs
o Drug markets and behavior economics

Emerging and current trends – Research directed at examining drug abuse 
trends is particularly important in the contemporary context where a variety 
of new substances are available to increasingly diverse populations and in an 
expanding range of settings.  Changing availability and changing social and 
cultural trends influence patterns of use.  Research continues to reveal new 
drug use trends and issues warranting further exploration such as the high 
level of abuse of prescription drugs, patterns of use of drugs in 
combination, and the association between non-injection drug use and HIV-risk 
behaviors in some contexts.  This program of research encourages: (a) studies 
that develop more effective and timely ways to identify the nature, extent, 
and changes of new trends at an early stage within local, national and 
international contexts, and to identify associated health, social and 
behavioral consequences; (b) theory-driven research models for understanding 
the diffusion of drug trends into new populations including the impact of 
cultural factors, social networks, drug distribution mechanisms and media; 
(c) exploratory descriptive hypothesis-generating ethnographic studies as 
well as analytic studies that examine factors impacting initiation, 
continuation, progression and cessation of use of novel drugs; (d) studies 
that examine the relation between the use of novel drugs and HIV-risk 
behaviors; (e) research into whether users of these new substances experience 
substance use disorders; and (f) innovative studies to improve methods for 
characterizing drug use behaviors such as, for example, the use of different 
substances strategically in combination or in sequence within specified 
periods of time.

Social epidemiology of drug abuse – Drug abuse research has focused largely 
on individual risk factors, while the universe of determinants includes 
individual, familial, neighborhood, community, population-specific, and 
societal factors.  There is urgent need to extend drug abuse research to 
incorporate the concept of interactivity (individual susceptibility 
interacting with social environment, genetic environment, neighborhood 
environment) and cumulative history (how these determinants differentially 
impose risk across time, generations, and the life course).  This program 
specifically encourages: (a) studies that examine the interaction of 
individual and social environmental factors on drug use/abuse/dependence; (b) 
studies that consider both immediate and cumulative (life-course and trans-
generational) effects of interactions among drug abusing behaviors, 
environments, and genes; (c) studies that draw upon current research on the 
effects of social environmental factors on health and disease in general; (d) 
research that identifies whether and how the environment as culture can be 
meaningfully disaggregated into measurable components and tested for effects 
on drug abuse; (e) studies that inform the debate on which aspects or 
dimensions of the social environment (e.g., society, social institution, 
small group, dyad) also should be included, when they should be included, and 
how they should be measured; (f) investigations of the collective impact of 
neighborhood factors such as residential stability/instability, collective 
efficacy, social cohesion or other aspects of locally shared environments on 
drug abuse among different groups; and (g) studies of how social and cultural 
factors influence or predict drug use/abuse and its consequences.

Familial/genetic liability and phenotypic heterogeneity – Numerous genetic 
epidemiologic studies confirm that drug abuse "runs" in families, and that 
such transmission is due in part to genetic factors.  These findings have 
been tremendously important, and have set the stage for additional research 
to specify drug abuse phenotype(s) and gene-by-environment interactions 
inherent to complex disorders such as drug abuse.  Indeed, untangling the 
complicated pathways from genotypes to phenotypes is one of the biggest 
challenges in the drug abuse field.  The objective of this program area is to 
further explicate the transmissibility of drug abuse phenotypes and to 
explicate individual differences, familial processes, and 
social/environmental factors that confer and/or protect against the 
expression of genetic liability.  This program area encourages research on 
the following topics: (a) the refinement of drug abuse phenotypes and 
nosology to inform prevention, services, and molecular genetic research; (b) 
identification of key individual and environmental characteristics that 
affect genetic vulnerability and/or the course of drug abuse, including 
psychopathological conditions; (c) clarification of gene-environment 
interactions for fine-tuning preventive interventions with high-risk 
populations; (d) studies that inform the debate on the general liability 
versus specificity of genetic risk for drug abuse; (e) genetically-
informative assessments that are nested within epidemiologic-based studies; 
(f) development of statistical and analytic approaches to model complex 
disorders and traits.  

Drug abuse psychopathology: comorbidity and vulnerability – Cross-sectional 
and longitudinal studies of adolescents and adults in both clinical and 
general populations have found high rates of co-occurrence between drug abuse 
and psychiatric disorders, particularly the conduct/antisocial disorders and 
the mood disorders.  Far fewer studies have examined the temporal order or 
causal relationships, including potentially common pathways, for specific 
psychiatric disorders and drug abuse.  Thus, the nature of the association 
among psychiatric and drug use disorders remains unclear.  Understanding the 
relations between precursor and comorbid psychiatric disorders and drug abuse 
is the focus of this program and has important prevention and treatment 
implications.  Specifically, this program of research encourages studies that 
focuses on: (a) child psychiatric precursors to drug abuse, with a particular 
emphasis on attentional, externalizing, and internalizing disorders; (b) the 
impact of mental health interventions on drug abuse risk; (c) moderating and 
mediating factors that can inform the association between psychiatric 
disorders and drug abuse; (e) temperament and personality, particularly 
behavioral disinhibition, as stand-alone etiologic or potential mediating 
factors; and (f) dynamic relations between the timing and course of 
psychiatric illness and the timing and course of drug abuse, including drug 
use initiation, maintenance, escalation, and remittance.  Towards this end, 
research approaches of particular interest to this program include: 
epidemiologic (population-based) cross-sectional and longitudinal studies, 
genetic epidemiologic and other studies of familial risk, clinical 
prospective and clinical follow-up studies, innovative designs that 
characterize the interactions between individual psychiatric and genetic 
factors with the environment, nested studies, and secondary data analyses.  
For additional information related to psychopathology vulnerability for drug 
abuse, see http://www.drugabuse.gov/Meetings/Childhood.  

Human development in adolescence and adulthood – This program focuses on 
three key adolescent developmental issues that have relevance for drug abuse: 
timing, transitions, and biologic maturation.  The developmental stage when 
drugs are introduced has implications for drug abuse, as evidenced by recent 
research showing that initiation during early developmental periods is 
associated with greater subsequent use.  Similarly, developmental transitions 
(e.g., pubertal, cognitive, social, and achievement related), and individual 
variation in the timing of these, are also likely to influence trajectories 
of use.  Studies of particular interest under this program include, but are 
not limited to, those that assess: (a) how developmental timing and the 
timing of drug use act and interact to influence the course of drug using 
behavior and related outcomes; (b) the implications of emerging cognitive, 
emotional, and social capacities across developmental periods for drug abuse; 
(c) the impact of the adoption of stage-specific roles on drug abuse and the 
impact of drug abuse on the adoption of such roles; (d) the creation of new 
or implementation of existing methodologic approaches that adequately capture 
the developmental nature of individual change; (e) real-time assessment 
methodologies to capture the capricious and context-dependent nature of drug 
using behaviors over developmental periods; and (f) translational research 
including epidemiologic studies that incorporate lab-based findings on 
adolescent brain development, measures of shifts in emotional and cognitive 
processes, and assessments of biological changes associated with puberty. 

Developmental consequences of drug abuse – This program focuses on the 
effects of parental drug abuse and its consequences (e.g., family violence, 
child maltreatment) on child development.  Parent drug abuse may influence 
children’s development through direct and indirect pathways.  Direct pathways 
include genetic transmission of vulnerability to substance use disorders and 
prenatal exposure to drugs.  Parent substance abuse can also indirectly 
impact development through its effect on children’s environments.  
Longitudinal, prospective, and multidisciplinary studies are needed to 
investigate the independent and combined contributions of biologic/genetic, 
psychosocial, and contextual factors that influence the development of 
children. Child populations at heightened risk for drug abuse (e.g., homeless 
youth, children in foster care) are of particular interest.  This program of 
research encourages studies that focus on factors related to parent drug 
abuse, as they relate to children’s drug abuse and other developmental 
outcomes as well as the processes by which these factors influence child 
development.  This program of research specifically encourages: (a) 
independent and combined effects of parental drug abuse, family violence and 
child maltreatment; (b) effects of exposure to lifestyles associated with 
illicit drug activities; (c) effects of forced parent-child separations due 
to parental drug related illness, death or imprisonment; (d) post-traumatic 
stress disorder (PTSD) affecting the child and parental drug abuse, family 
violence, and/or child maltreatment; and (e) child characteristics and family 
dynamics that contribute to associations between parental drug abuse and 
child maltreatment and between parental drug abuse, family violence and/or 
child maltreatment and related child outcomes. 

Social and behavioral consequences of street drugs – This program examines 
the range of behavioral and social consequences arising from street-level 
drug abuse.  Behavioral consequences include educational and occupational 
problems, crime and violence, and comorbid conditions (overdose, suicide, 
cognitive impairment).  Social consequences include drug trafficking and 
distribution, gang activities, family disruption, and neighborhood 
dysfunction.  Little attention has been given to how abuse of particular 
drugs and combinations of drugs affects these consequences.  Understanding 
retail street drug activity and consumption patterns is key to understanding 
drug distribution networks and drug price/purity and availability.  Data are 
available on the frequency of drug use, but better estimates of drug 
price/purity, and a better understanding of the quantity of drug used are 
sorely needed.  Specifically, the street-level drugs program encourages 
research on: (a) what, how much, and how often drugs are actually consumed by 
drug users; (b) which adulterants, diluents, and contaminants are present in 
retail drugs; (c) the patterns of use of different drugs, including teasing 
apart patterns of polydrug use; (d) economic analyses to understand issues 
such as price/purity, consumption, and cross-elasticities; (e) small-scale 
epidemiologic studies could characterize price, demand, and consequences at 
the level of a city or other small geographic area; and (f) ethnographic 
studies to describe price and availability effects on behavior of those who 
use, abuse, or are dependent to explore whether elasticity of demand varies 
with severity of drug use.

Drug markets and behavior economics – Research increasingly points to the 
importance of studying drug abuse as the behavior of individuals in their 
environments.  While the immediate (proximal) environments of drug abusers 
have received considerable research attention, the context of broader and 
more distal environmental influences have received less consideration.  
Principles of behavior derived from more macro-environmental disciplines, 
particularly economics, have great potential for expanding understanding of 
the full set of influences on drug abuse.  It is important to examine the 
intersection of psychological, economic and environmental concepts and 
findings and their relevance to drug abuse etiology, continuation, relapse 
and hopefully, more effective preventive and treatment interventions.  By 
applying the research and perspectives of behavioral economics, marketing 
research, drug availability market factors, the psychology of decision making 
and other related areas, important but understudied pieces of the drug abuse 
puzzle will be investigated.  The following issues are of particular 
interest: (a) nested case control studies within larger epidemiologic studies 
that enable laboratory-based behavioral economic analysis of defined 
populations; (b) research on the influence of environmental factors on 
behavioral economic measures such as delayed discounting functions or 
impulsivity and risk taking; and (c) interactions among broad social forces 
(e.g., neighborhood quality and socioeconomic status), racial and ethnic 
health disparities, and drug abuse trajectories and consequences.

MECHANISMS OF SUPPORT 

This PA will use the NIH research grant (R01) award mechanism, NIH small 
grant award (R03), and the NIH exploratory/developmental award (R21).  The 
applicant will be solely responsible for planning, directing, and executing 
the proposed project.  

This PA 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.  

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 your inquiries concerning this PA and welcome the opportunity to 
answer questions from potential applicants.  Inquiries may fall into two 
areas:  scientific/research and financial or grants management issues:

o Direct your questions about scientific/research issues to:

Yonette Thomas, Ph.D.
Division of Epidemiology, Prevention, and Services Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5169, MSC 9589
Bethesda, MD  20892-9589
Rockville, MD  20852 (for express/courier service)
Telephone:  301-402-1910
Fax:  (301) 480-2543
Email:  yuthomas@mail.nih.gov

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

Gary Fleming, J.D.
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270, MSC 8403
Bethesda, MD  20892-9605
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-6710
FAX:  (301) 594-6849
Email:  gfleming@nida.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 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.

The title and number of this program announcement must be typed on line 2 of 
the face page of the application form and the YES box must be checked.

APPLICATION RECEIPT DATES: Applications submitted in response to this program 
announcement will be accepted at the standard application deadlines, which 
are available at http://grants.nih.gov/grants/dates.htm.  Application 
deadlines are also indicated in the PHS 398 application kit.

SPECIFIC INSTRUCTIONS FOR MODULAR BUDGET GRANT APPLICATIONS: Applications 
requesting up to $250,000 per year in direct costs must be submitted in a 
modular budget grant format.  The modular budget 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.

SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: 
Applications requesting $500,000 or more in direct costs for any year must 
include a cover letter identifying the NIH staff member within one of NIH 
institutes or centers who has agreed to accept assignment of the application.   

Applicants requesting more than $500,000 must carry out the following steps:
   
1) Contact IC program staff at least 6 weeks before submitting the 
application, i.e., as you are developing plans for the study; 

2) Obtain agreement from IC staff that IC will accept your application for 
consideration for award; and,
  
3) Identify, in a cover letter sent with the application, the staff member       
at NIDA who agreed to accept assignment of the application.  

This policy applies to all investigator-initiated new (type 1), competing 
continuation (type 2), competing supplement, or any amended or revised 
version of these grant application types. Additional information on this 
policy is available in the NIH Guide for Grants and Contracts, October 19, 
2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. 

SENDING AN APPLICATION TO THE NIH: 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)

APPLICATION PROCESSING: Applications must be mailed on or before the receipt 
dates described at 
http://grants.nih.gov/grants/funding/submissionschedule.htm.  The CSR will 
not accept any application in response to this PA 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 a substantial revision of an unfunded version of an application 
already reviewed, but such application must include an Introduction 
addressing the previous critique.  

Although there is no immediate acknowledgement of the receipt of an 
application, applicants are generally notified of the review and funding 
assignment within 8 weeks.

PEER REVIEW PROCESS

Applications submitted for this PA will be assigned on the basis of 
established PHS referral guidelines.   Appropriate scientific review groups 
convened in accordance with the standard NIH peer review procedures 
(http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific 
and technical merit.  

As part of the initial merit review, all applications will:

o Undergo a selection process in which only those applications deemed to have 
the highest scientific merit, generally the top half of applications under 
review, will be discussed and assigned a priority score
o Receive a written critique
o Receive a second level review by an 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 evaluate 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.

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?

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?

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?

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)?

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 
items will be considered in the determination of scientific merit and the 
priority score:

PROTECTION OF HUMAN SUBJECTS FROM RESEARCH RISK: The involvement of human 
subjects and protections from research risk relating to their participation 
in the proposed research will be assessed. (See criteria included in the 
section on Federal Citations, below).
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

INCLUSION OF WOMEN, MINORITIES AND CHILDREN IN RESEARCH: 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 will be assessed.  Plans for the recruitment and retention of 
subjects will also be evaluated. (See Inclusion Criteria in the sections on 
Federal Citations, below).

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

AWARD CRITERIA

Applications submitted in response to a PA will compete for available funds 
with all other recommended applications.  The following will be considered in 
making funding decisions:  

o Scientific merit of the proposed project as determined by peer review
o Availability of funds 
o Relevance to program priorities

REQUIRED FEDERAL CITATIONS 

HUMAN SUBJECTS PROTECTION:  Federal regulations (45CFR46) require that 
applications and proposals involving human subjects must be evaluated with 
reference to the risks to the subjects, the adequacy of protection against 
these risks, the potential benefits of the research to the subjects and 
others, and the importance of the knowledge gained or to be gained. 
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

DATA AND SAFETY MONITORING PLAN: Data and safety monitoring is required for 
all types of clinical trials, including physiologic, toxicity, and dose-
finding studies (phase I); efficacy studies (phase II), efficacy, 
effectiveness and comparative trials (phase III). The establishment of data 
and safety monitoring boards (DSMBs) is required for multi-site clinical 
trials involving interventions that entail potential risk to the 
participants. (NIH Policy for Data and Safety Monitoring, NIH Guide for 
Grants and Contracts, June 12, 1998: 
http://grants.nih.gov/grants/guide/notice-files/not98-084.html).  

SHARING RESEARCH DATA:  Investigators submitting an NIH application seeking 
$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.

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

INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS: 
The NIH maintains a policy that children (i.e., individuals under the age of 
21) must be included in all human subjects research, conducted or supported 
by the NIH, unless there are scientific and ethical reasons not to include 
them. 

All investigators proposing research involving human subjects should read the 
"NIH Policy and Guidelines" on the inclusion of children as participants in 
research involving human subjects that is available at 
http://grants.nih.gov/grants/funding/children/children.htm. 

REQUIRED EDUCATION ON THE PROTECTION OF HUMAN SUBJECT PARTICIPANTS: NIH 
policy requires education on the protection of human subject participants for 
all investigators submitting NIH proposals for research involving human 
subjects.  You will find this policy announcement in the NIH Guide for Grants 
and Contracts Announcement, dated June 5, 2000, at 
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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. 

NATIONAL ADVISORY COUNCIL ON DRUG ABUSE RECOMMENDED GUIDELINES FOR THE 
ADMINISTRATION OF DRUGS TO HUMAN SUBJECTS:  The National Advisory Council on 
Drug Abuse recognizes the importance of research involving the administration 
of drugs to human subjects and has developed guidelines relevant to such 
research.   Potential applicants are encouraged to obtain and review these 
recommendations of Council before submitting an application that will 
administer compounds to human subjects.  The guidelines are available on 
NIDA's Home Page at http://www.nida.nih.gov under the Funding, or may 
be obtained by calling (301) 443-2755.

HIV/AIDS COUNSELING AND TESTING POLICY FOR THE NATIONAL INSTITUTE ON DRUG 
ABUSE:  Researchers funded by NIDA who are conducting research in community 
outreach settings, clinical, hospital settings, or clinical laboratories and 
have ongoing contact with clients at risk for HIV infection, are strongly 
encouraged to provide HIV risk reduction education and counseling.  HIV 
counseling should include offering HIV testing available on-site or by 
referral to other HIV testing service for persons at risk for HIV infection 
including injecting drug users, crack cocaine users, and sexually active drug 
users and their sexual partners.  For more information see 
http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

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

Applicants may wish to place data collected under this 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).  

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://grants.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 PA 
is related to one or more of the priority areas. Potential applicants may 
obtain a copy of "Healthy People 2010" at http://www.healthypeople.gov/.

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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