Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (
Canadian Institutes of Health Research (CIHR), (

Components of Participating Organizations
National Institute on Drug Abuse (NIDA), (
National Institute of Alcohol Abuse and Alcoholism (NIAAA), (
National Institute on Aging (NIA), (
Institute of Neurosciences, Mental Health and Addiction (INMHA), (

Title: Social Neuroscience

Announcement Type

Request For Applications (RFA) Number: RFA-DA-06-004

Catalog of Federal Domestic Assistance Number(s)
93.279, 93.273, 93.866

Key Dates
Release Date: November 10, 2005
Letters of Intent Receipt Date(s): January 23, 2006
Application Receipt Dates(s): February 23, 2006
Peer Review Date(s): June 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: September 2006
Additional Information to Be Available Date (Url Activation date):
Expiration Date: February 24, 2006

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
  1. Research Objectives

Section II. Award Information
  1. Mechanism(s) of Support
  2. Funds Available

Section III. Eligibility Information
  1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
  2.Cost Sharing or Matching
  3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
  1. Address to Request Application Information
  2. Content and Form of Application Submission
  3. Submission Dates and Times
    A. Receipt and Review and Anticipated Start Dates
      1. Letter of Intent
    B. Sending an Application to the NIH
    C. Application Processing
  4. Intergovernmental Review
  5. Funding Restrictions
  6. Other Submission Requirements

Section V. Application Review Information
  1. Criteria
  2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
  3. Reporting

Section VII. Agency Contact(s)
  1. Scientific/Research Contact(s)
  2. Peer Review Contact(s)
  3. Financial/ Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives


The National Institute on Drug Abuse (NIDA), The National Institute on Alcohol Abuse and Alcoholism (NIAAA), and The National Institute on Aging (NIA) invite applications examining the emotional, behavioral, and cognitive processes and neurobiological mechanisms of social behavior as these influence, mediate, or are influenced by: (1) alcohol and drug abuse; and (2) social, economic, and health-related decisions that impact the health and well-being of adults and the elderly. The intent of this Request for Applications (RFA) is to act as a catalyst for the emerging area of social neuroscience in order to elucidate fundamental neurobiological mechanisms of social behavior relevant to (1) alcohol and/or drug abuse at different stages of brain development; and (2) life course decision making.  Clinical and preclinical research supported by this initiative must take a multidisciplinary, multilevel approach to a social behavioral research question (or set of questions) that is framed at the behavioral level (e.g., social cognition, social development, social interaction, and social aspects of emotion) and examines the relationship between behavior and neurobiological and/or genetic processes.

New technologies for studying the human brain are beginning to make it possible to engage in a systematic examination of the neurobiological mechanisms involved in social cognitive and affective information processing, and social behavior.  Similarly, new animal models make it possible to study the genetic, molecular, and neurobiological systems that underlie social behavior; to reveal how environmental and etiological events interact with biological processes to direct the development of social behavior; and to study how social behavior can, in turn, influence neural processes and protein and gene expression through epigenetic processes.  Ultimately, investigating how the brain controls social functions will contribute to an understanding of the social cognitive processes and biological mechanisms involved in social behaviors related to (1) alcohol and/or drug abuse, including alcohol and drug abuse-related social behaviors associated with increased risk for HIV/AIDS (NIDA/NIAAA) and (2) life course decision making more broadly conceived (NIA).

Please note: The term "drug/alcohol abuse" as used in this RFA refers broadly to several different but related concepts including drug/alcohol abuse and drug/alcohol dependence as defined by diagnostic criteria, as well as drug/alcohol involvement, hazardous drug/alcohol use, drug/alcohol seeking behavior, and the like.  While it is recognized that these concepts may not be interchangeable, the term drug abuse is used for the purposes of fluency. 

General Background

Social neuroscience seeks to explain social behavior (i.e., behavior influenced by or occurring in the presence of others) in terms of:(1) the information processing mechanisms that motivate and guide social behavior; and (2) the neurobiological mechanisms (genetic, hormonal, biochemical, physiological) that underlie social behavior.  The social neuroscience perspective (and related areas of neuro- and behavioral economics) is an emerging framework that is being applied to important aspects of social behavior and experience including attraction, altruism, aggression, affiliation, attachment, attitudes, identification, cooperation, competition, social decision making (including economic exchange), emotion, motivation, empathy, moral judgment, sexuality, communication, dominance, persuasion, trust, obedience and nurturance.  This RFA seeks to encourage new research that applies the social neuroscience perspective to (1) alcohol and/or drug abuse (NIDA/NIAAA) and (2) social factors in decision making (NIA).

Although neuroscientific methods have already contributed to major advances in research on basic cognitive processes such as memory, attention, and learning, there is little understanding of the neural basis of social cognition, emotion and behavior, and much less research in this area focusing on issues of alcohol and/or drug abuse or on aging.  The social environment, itself, is multifaceted and comprises a dynamic set of environmental and behavioral interactions that influence the connections among individuals such as, parent and child, husband and wife, groups, institutions, and societies.   These connections, in turn, form the social network that can have an impact on brain development and function, cognition, emotion and behavior.  Research is still needed to explicate the specific pathways by which social behavioral processes and experiences influence and are influenced by brain function during the different life stages.  Applying the concepts and tools of neuroscience (e.g., brain imaging, multi- and single unit recordings, work with brain-damaged patients, lesion methods, study of neurodegenerative diseases, transcranial magnetic stimulation (TMS), computational modeling, psychophysiological, neuroendocrine and genetic methods) can help shed new light on areas of inquiry in social psychological processes, such as: attitude change, stereotyping, gender differences, person perception, social decision making, empathy and interpersonal relationships, as well as self-perception, self-regulation, and emotion-regulation.  Likewise, social and developmental behavioral research has a repertoire of sophisticated paradigms for subtle manipulations and detection of affect, attention, or motivation that offer considerable promise for linking neuroscience investigations with social behaviors.  Importantly, understanding the neural basis of social psychological processes also can contribute to the advancement of knowledge regarding the development of, and possible gender differences among these processes across the life span.

Animal research is expected to play a fundamental role in generating a comprehensive understanding of the development and complexities of natural behaviors, the manners in which they are influenced by the social environment, and the neural and physiological processes underlying their normal, aberrant, and diseased (i.e., alcohol/drug-addicted) manifestations.  Animal models are ideally suited for exploring the neurobiological correlates of the reciprocal interactions between the causes and effects of alcohol and/or drug abuse and optimal or adaptive (i.e. well-being promoting) choice, and such social interactions that can be studied in animals such as grooming, nurturing, maternal care, social stress, sexual behavior, social conditioning, play, imitation, social imprinting and learning, social hierarchies and environmental enrichment.  These animal models make it possible to study the interactions between genes, neurobiological processes and social factors that contribute to alcohol and drug abuse or adaptive decision making and to test hypotheses by the manipulation of social, biological and genetic variables.  Note that this RFA encourages the development of animal models of social behavior that can be applied to mice to take advantage of advances in knockout and transgenic technologies.

NIDA and NIAAA Interests:

Drug/alcohol abuse is a complex phenomenon that is affected by variables operating at many levels of functioning from the neurobiological (e.g., variation in receptor function) to the social (e.g., dominance hierarchies).  Whereas neurobiological variables have been well represented in the scientific literature on alcohol and drug abuse, social context variables have only recently begun to appear in well-controlled studies.  Social context is an important contributor to the initiation, escalation, maintenance, relapse to, and consequences and treatment of alcohol and drug abuse.  For example, association with drug/alcohol using peers is a major risk factor for the initiation and escalation of drug use, as well as for relapse due, in part, to induction or increase in craving.  Similarly, many of the consequences of alcohol/drug use and abuse are inherently social, including impaired relationships, job loss, estrangement from family, or incarceration.  An understanding of social cognitive processes that operate within a peer setting, such as those involved in decision-making, may be key to explaining peer influence on drug/alcohol initiation, or the failure of individuals to seek drug/alcohol treatment.  Social context can be both a risk factor for alcohol and drug abuse and a protective factor against it.  Therefore, effective interventions for alcohol and drug abuse rely on recruiting and harnessing a host of social variables.  Drug and alcohol related social behaviors can also lead to HIV/AIDS.   For example, risky sexual behavior is associated with intoxication with drugs or alcohol as well as trading sex for drugs, while needle sharing also increases the risk of HIV infection.  Effective HIV/AIDS prevention and treatment for alcohol and drug abusers would, therefore, also benefit from research on social behavior.  Despite a wealth of anecdotal reports and limited empirical data attesting to the importance of social context in alcohol and/or drug abuse, there remains a great deal to be learned about the cognitive/behavioral processes and the neurobiological mechanisms that mediate the effects of social context on alcohol and drug abuse. 

There is good reason to expect that the social factors that influence alcohol and/or drug abuse, and their neurobiological underpinnings, will vary during the course of human development.  Vast changes in the frontal cortex and its connections with limbic brain regions that occur during adolescence may be associated with changes in social information processing, emotional reactivity and behavior, including alcohol and/or drug abuse.  A social neuroscience perspective, therefore, might explain the higher prevalence of drug/alcohol use during adolescence.  As children age into adolescence, there is a growing preference for affiliation with peers (rather than family) and these peers exert increasing influence on behavior.  Alcohol and drug abuse, therefore, may be related not only to misjudging the negative consequences of alcohol/drug use, but also to hypersensitivity to social facilitation of alcohol/drug use and, reciprocally, to drug-induced facilitation of social behavior.  In addition, adolescents’ decision-making processes (e.g., peer-based “hot” cognitions) differ from adults’ in ways that are likely to strongly influence alcohol/drug-using behaviors.  Thus, a confluence of neurobiological mechanisms related to brain development, and the brain’s response to alcohol and drugs of abuse and to the social environment can have a profound impact on alcohol and drug abuse.  Gender differences, too, emerge in a social context on a developmental trajectory to influence patterns of decision-making, risk taking and alcohol and/or drug abuse initiation.  Research is needed to identify the neurobiological mechanisms related to these socially grounded developmental events.

NIAAA Interests

NIAAA is interested especially in basic research that can inform interventions to reduce underage drinking and its associated harms through increased understanding of the interplay of multiple developmental processes and adolescent drinking pathways.  Research in humans and animals has shown that social factors and contexts, social perceptions, positive and negative expectancies, peer and social pressures/affiliations, social status concerns, early maternal relationships, emotional self-regulation, and decision making processes all contribute to developmental drinking pathways.  Furthermore, drinking exposure during adolescence may differ for boys and girls, depending on maturational levels, and consequent social perceptions and experiences.   Therefore, research is needed using a developmental perspective (pre-adolescent through young adult) to study the neurobiological and epigenetic mechanisms underlying the social and emotional behaviors involved in the initiation, escalation and maintenance of drinking.  Further research is also needed to understand the degree to which alcohol exposure during childhood and adolescence may modify these neural and genetic developmental processes, resulting in the persistence of drinking or the transition to problem drinking throughout adolescence and into early adulthood.  

For both animal and human studies, NIAAA encourages concomitant accrual of relevant developmental information (e.g., pubertal stage, and in humans, cognitive developmental stage).  Developmental factors such as pubertal stage and cognitive development may influence social and emotional measures as well as alcohol intake.  Therefore, simultaneous consideration of these kinds of factors will result in more developmentally informative studies.  Sex differences in social and neurobiological maturational processes as they relate to drinking behavior are also a priority.

NIA Interests:

As individuals age, they continually face new sets of decisions in social, economic, and health domains. The outcomes of these choices have consequences for individuals’ well-being in both the short and long term. While decision making is frequently studied from an individual psychological perspective, choices are invariably situated within a social context. Specifying how social factors influence emotion, motivation, and choice in decision making across the lifespan is a critical goal for life-span developmental research. Despite the growing appreciation of the important role of social factors in decision-making, little attention has yet been paid to this topic in the study of decision-making in normal aging.  In part, this may be due to the general paucity of studies on aging and decision-making.  Historically, however, it is only recently that a clear picture is emerging of the diverging trajectories of cognitive and socioemotional functioning over the course of adulthood, making it possible now to consider how age-related socioemotional changes might impact the decision processes of people at later stages of life.

Though numerous cognitive functions, including the encoding, maintenance, and retrieval of factual information in memory, the inhibition of irrelevant information, and speed of processing (all of which are important for decision making) decline with age, there is evidence that socioemotional abilities, including interpersonal problem solving, and the ability to experience emotion and process emotionally salient information in both social and nonsocial contexts is largely preserved. Moreover, changes in emotional and social goals at the end of life may interact with decision behaviors in as yet unknown ways.  While the experience and expression of emotion remains intact with age, the emotional goals associated with different life stages influence whether and which emotions will arise in different contexts, and have different implications for the regulation of their expression.  For example, accumulating evidence suggests that older adults manage their emotions and social conflicts more effectively, so that the overall pattern of their emotional life is predominantly positive. Age-related changes in emotionally meaningful goals may influence, in turn, the structure of the social network, choices of social partners, or prime the use of strategies favoring the regulation of emotional states and maintenance of close relationships over other instrumental or interpersonal goals. How the differing strengths of emotional, cognitive and physical capacities at different life stages, in combination with life course changes in motivation and goals, impact decision making at different life stages is as yet unknown. Furthermore, how neurobiological changes in older adults such as decreases in brain matter and reductions in neurotransmitter function on the one hand, and neurogenesis and neuroplasticity on the other, influence or are influenced by these social and motivational factors is virtually unexplored.  Social neuroscience has the potential to shed light on how these biological, social, and psychological changes that influence complex processes such as emotion regulation in decision contexts, affective forecasting, social interaction, and social decision-making, with implications for how we evaluate well-being in older age.  Knowledge of such age-related changes may ultimately guide the structuring of decision-supportive interventions and policies affecting the choices individuals make as they approach the end of life.

NIA, therefore,  is interested in multilevel research (combining behavioral with neuroendocrine, genetic, or neurophysiological methods) on social and socioemotional influences on decision making and their development and manifestation over adulthood, and their impact on social, economic, and health-related choices that impact well-being in adulthood, older age, and at the end of life.  NIA solicits applications on the role of social emotions, values, social understanding, social context, social networks, and institutions of interpersonal exchange on decision making in domains relevant to later life, such as retirement and investment planning, transfer of wealth across generations, health behaviors, financial decisions, and attitudes about fairness and reciprocity.  These include, but are not limited to: factors influencing trustworthy, cooperative, altruistic and trusting behaviors; the ability to accurately detect and predict the motivations, intentions and preferences of oneself and others in social contexts, as well as changes in these capacities over time; assessment of social risks; social contexts that facilitate or undermine adaptive decisions, and how social context constrains interpersonal decision processes; how social factors like loneliness and the quality of social networks and communities impact individual and collective decision making; the impact of stress related to changes in social networks (e.g., due to bereavement or movement to assisted living or nursing home) on motivation and choice; the influence of social factors on the stability of preferences and quality of decisions over the life course.  Research on age-related changes in basic socioemotional capacities such as empathy and other aspects of socioemotional understanding and their influences on choice and economic and health behaviors are also of interest.  Research exploring, from a developmental perspective, the causes and consequences of individual differences in social decision making for health, relationship quality, social judgment and adjustment, and decision outcomes is also appropriate.

Objectives and Scope

General Characteristics of Responsive Applications

Only multidisciplinary, multilevel proposals that integrate genetic or neurobiological and behavioral approaches involving social processes (including those studied under a neuro- or behavioral economic framework) that are relevant to the problems of alcohol and drug abuse or life course social, economic, or health-related decision making will be considered responsive to this RFA.  Moreover, the research questions must focus on social processes or interpersonal interactions that are relevant to alcohol and/or drug abuse or life course decision making.  Proposals that do not have an overriding emphasis on both social processes and genetic or neurobiological processes, or do not clearly provide a justification of how the research potentially advances our understanding of (1) alcohol and/or drug abuse or aspects of HIV/AIDS risk behaviors in the context of alcohol and drug abuse or (2) life course social, economic, or health-related decision making, are not appropriate for this RFA.  Studies may be at either the clinical (human) or pre-clinical (animal) level. 

For the purposes of this RFA, social processes are defined as interactions between two or more individuals/organisms.  Appropriate research could also involve the presentation of social stimuli including, for example, computer generated “social responses,” presentations of facial or bodily postures and expressions, vocalizations and other sensory communications, or in the case of human studies requiring a person to adopt the perspective of a second person (e.g., theory of mind). 

Both hypothesis-driven and exploratory research proposals will be supported under this RFA.  Pilot data establishing proof of concept are not necessary for exploratory research, but the exploratory nature of the study must be clearly stated.  Exploratory research does require demonstration of proof of feasibility for the project and documentation of the appropriate expertise of the investigators.  

Although applications can be from single investigators, collaborations are encouraged, particularly between social or behavioral scientists and neuroscientists or geneticists.  Investigators need not demonstrate a history of prior collaboration, but must delineate factors that will facilitate success of the planned collaboration.  Collaborations between different departments or institutions (including those at other geographic locations) are acceptable.  However, the applicants must demonstrate how they will communicate across these boundaries so that fully developed collaborative research partnerships can occur.  Proposed research could build on, or collaborate with (1) ongoing or existing alcohol and drug abuse prevention and treatment intervention programs (NIDA/NIAAA) or (2) with ongoing or existing longitudinal studies of biopsychosocial influences on health and well-being (NIA).

For NIDA, use of patient populations or pharmacological approaches is not required, but studies incorporating either drug abusers or administration of drugs of abuse (in animals or under appropriate conditions with human volunteers) are highly encouraged.  Also encouraged is the investigation of adolescents and young adults who are the most vulnerable to alcohol and drug abuse.  However, if a patient or drug-using population or drug administration is not used, there must be a clearly stated rationale of how the proposed studies will advance understanding of drug abuse, or how the proposed studies would be expanded in the future to incorporate drug administration and/or patient or drug-using populations. 

For NIAAA, only studies in humans or animals where the target substance administered is alcohol or, in humans, where the primary focus of the study is alcohol use will be considered. Basic developmental research on the neurobiological mechanisms of social cognition and behavior, even if it could be applied to alcohol research in the future, will not be considered responsive to NIAAA’s portion of this RFA. 

Research Scope

Applications in response to this RFA must combine neurobiological or genetic with social behavioral or social cognitive approaches with the goal of understanding social behavior as applied to the institute-defined focal topics of this RFA.  In any of these areas of social behavior, developmental studies and studies designed to explore gender differences and alcohol and/or drug-abuse related social behaviors associated with increased risk for HIV/AIDS are also encouraged (NIDA/NIAAA).  Neuroscience approaches that are relevant include examinations of neural systems, structures, circuits, or processes.  Applications with a genetic component are encouraged if the focus is on understanding genetic effects on neural mechanisms involved in social behavior, or on behavioral influences on gene expression in the brain

Sample Research Topics

The following are examples of broad research topics that might be the focus of this social neuroscience RFA. NIDA is interested in all the topics listed below  NIAAA is only interested in these topics from a developmental perspective, particularly as they relate to preadolescent and adolescent drinking pathways including the development of abuse and dependence.  NIA is only interested in these topics insofar as they address social aspects of decision making from a life-span developmental perspective.  At the present time, NIAAA and NIA are not interested in the topic of Treatments and Interventions.  The list is not meant to be comprehensive, nor are the examples meant to be exclusive of other topics.  These topics provide examples of social behaviors, and it is assumed that all proposals will take a multidisciplinary, multilevel approach to these topics.  Researchers are also encouraged to set forth theory-driven, sex/gender-based hypotheses and to analyze date separately for males and females. 

Social Cognition and Emotion:

Animal Models


Treatments and Interventions

This section reflects the interests of NIDA only.  At the present time NIAAA, and NIA, and are not interested in applications in these areas.

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information

1. Mechanism(s) of Support

This funding opportunity will use the R01 research project grant and the R21 exploratory/development grant award mechanisms.

As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This funding opportunity uses just-in-time concepts. It also uses the modular as well as the non-modular budget formats (see Specifically, if you are submitting an application with direct costs in each year of $250,000 or less, use the modular budget format described in the PHS 398 application instructions. Otherwise follow the instructions for non-modular research grant applications.

2. Funds Available

NIDA intends to commit approximately $3.5 million dollars in FY 2006 to fund 10-15 new and/or competitive continuation grants in response to this RFA.  NIAAA intends to commit approximately $750,000 to fund 1-3 new and/or competitive continuation grants in response to this RFA. NIA intends to commit approximately $1,000,000 to fund 2-4 new and/or competitive continuation grants in response to this RFA. 

An application may request for the R01 a project period of up to 5 years and a budget for direct costs up to $500,000 per year. The R01 mechanism may be particularly appropriate to support the expansion or extension of research into important directions by investigative teams that have already been studying the effects of alcohol and drugs of abuse.  It may also be particularly appropriate to support the extension and application into the area of alcohol and drugs of abuse by investigative teams experienced with social neuroscience paradigms that had not previously examined alcohol and drug abuse effects. 

An application may request for the R21, a project period of up to 3 years and a budget for direct costs up to $250,000 for each of those years. This RFA seeks to encourage exploratory studies that may involve new collaborations among investigators from different fields. For purposes of this RFA, these types of new collaborations may be viewed as high risk and innovative. New collaborations will not be expected to have yielded much, if any preliminary data, although the individuals or groups involved in the collaborations should be expected to demonstrate feasibility of their contributions to the collaboration.

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. The earliest anticipated start date is September 2006.

Note that Research Plans for both the R01 and R21 applications submitted in response to this RFA are limited to 25 pages.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

1.B. Eligible Individuals

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.

2. Cost Sharing or Matching
No cost sharing is required.

3. Other-Special Eligibility Criteria
Not applicable 

Section IV. Application and Submission Information

1. Address to Request Application Information

The PHS 398 application instructions are available at in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email:

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at The D&B number should be entered on line 11 of the face page of the PHS 398 form.

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

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide a unique research opportunity not available in the U.S.

3. Submission Dates and Times
Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

3.A. Receipt, Review and Anticipated Start Dates

Letters of Intent Receipt Date(s): January 23, 2006
Application Receipt Dates(s): February 23, 2006
Peer Review Date(s): June 2006
Council Review Date(s): September 2006
Earliest Anticipated Start Date: September 2006

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

The letter of intent should be sent to:

Director - DA-06-004
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538

3.B. Sending an Application to the NIH

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

Personal deliveries of applications are no longer permitted (see

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Director - DA-06-004
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538

Using the RFA Label: The RFA label available in the PHS 398 application instructions 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:

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the National Institute on Drug Abuse. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity 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.

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

4. Intergovernmental Review
This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement

6. Other Submission Requirements

Specific Instructions for Modular Grant applications.

Applications requesting up to $250,000 per year in direct costs must be submitted in a modular budget format. The modular budget 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 at includes step-by-step guidance for preparing modular budgets. Applicants must use the currently approved version of the PHS 398. Additional information on modular budgets is available at

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

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 the priority score.

Sharing Research Resources

NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (NIH Grants Policy Statement and Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

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:

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria 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 an 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 or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators 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? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to 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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 the Research Plan, Section E on Human Subjects in the PHS Form 398).

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 Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

 Data Sharing Plan: 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 the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources
NIH policy requires that grant awardee recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (See the NIH Grants Policy Statement and Investigators responding to this funding opportunity should include a sharing research resources plan addressing how unique research resources will be shared or explain why sharing is not possible.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

3. Anticipated Announcement and Award Dates
Not applicable

Section VI. Award Administration Information

1. Award Notices

 If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General (

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of  Award will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the Notice of Award. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General ( and Part II Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities (

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

3. Reporting

Awardees will be required to submit the PHS Non-Competing Grant Progress Report, Form 2590 annually ( and financial statements as required in the NIH Grants Policy Statement.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity 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:

1. Scientific/Research Contacts:

Paul Schnur, Ph.D.
Deputy Director
Division of Basic Neuroscience and Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard, Rm. 4282, MSC 9555
Bethesda, MD 20892-9555
Tel: 301-443-1887
Fax: 301-594-6043

Lis Nielsen, Ph.D.
Psychological Development and Integrative Science
Behavioral and Social Research
National Institute on Aging
7201 Wisconsin Ave., Suite 533
Bethesda, MD 20892-
Tel: 301-402-4156
Fax: 301-402-0051

Ellen D. Witt, Ph.D.
Division of Neuroscience and Behavioral Research
National Institute on Alcohol Abuse and Alcoholism
5635 Fishers Lane, Rm 2063, MSC 9304
Bethesda, MD 20892-9304
Tel: 301-443-6545
FAX: 301-443-1650

2. Peer Review Contacts:

Teresa Levitin, Ph.D.
Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538

3. Financial or Grants Management Contacts:

Deborah S. Wertz   
Grants Management Branch/OPRM
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 270
Bethesda, MD 20892
Telephone: (301) 443-6710
FAX: (301) 594-6849

Judy Fox
Chief, Grants Management Branch
National Institute on Alcohol Abuse and Alcoholism/NIH/DHHS
5635 Fishers Lane, Room 3023, MSC 9304
Bethesda, MD  20892-9304
Phone:  (301) 443-4704
FAX:  (301) 443-3891

Janis Peterson
Grants Management Branch
National Institute on Aging/NIH/DHHS
7201 Wisconsin Ave, Suite 2N212
Bethesda, MD 20892-9205
Telephone: (301) 496-7739
FAX: (301) 401-3672

Section VIII. Other Information

Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals ( as mandated by the Health Research Extension Act of 1985 (, and the USDA Animal Welfare Regulations ( as applicable.

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 (

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). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts,

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 (

Investigators should seek guidance from their institutions, on issues related to institutional policies and 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.

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 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 Applicants may wish to place data collected under this funding opportunity 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.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

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 (; a complete copy of the updated Guidelines is available at 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 Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical 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 (

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 applications for research involving human subjects and individuals designated as key personnel. The policy is available at

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at and at Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding ( 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.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system ( at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process please visit the NIH Public Access Policy Web site at and view the Policy or other Resources and Tools including the Authors' Manual (

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 ( 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

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

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 under the Funding, or may be obtained by calling (301) 443-2755.

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

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at 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

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.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see:

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NIH Funding Opportunities and Notices

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