Part I Overview Information

Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH),

Components of Participating Organizations
National Institute on Drug Abuse (NIDA/NIH),

Title: Epidemiology Of Drug Abuse (R21)

Announcement Type
This is a reissue of PA-04-100, which was previously released May 3, 2004, and is now divided into separate Funding Opportunity Announcements (FOAs) for R21, R03, and R01 grant mechanisms.

Update: The following update relating to this announcement has been issued:

NOTICE: Applications submitted in response to this FOA for Federal assistance must be submitted electronically through ( using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 


This FOA must be read in conjunction with the application guidelines included with this announcement in for Grants (hereafter called

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PA-06-329

Catalog of Federal Domestic Assistance Number(s)

Key Dates
Release/Posted Date:  April 7, 2006
Opening Date: May 2, 2006 (Earliest date an application may be submitted to
Letters of Intent Receipt Date(s): Not Applicable
NOTE:  On time submission requires that applications be successfully submitted to no later than 5:00 p.m. local time (of applicant institution/organization).
Application Submission/Receipt Date(s):  Standard dates apply, please see
AIDS Application Submission/Receipt Date(s):  Please see
Peer Review Date(s): Please see
Council Review Date(s): Please see
Earliest Anticipated Start Date(s): See
Additional Information To Be Available Date (URL Activation Date): Not Applicable
Expiration Date: September 8, 2007 

Due Dates for E.O. 12372
Not Applicable.

Additional Overview Content

Executive Summary

This Funding Opportunity Announcement (FOA) issued by the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), is intended to support exploratory/ developmental research projects that address 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. The Exploratory/ Developmental grant (R21) is carried out for early and conceptual research development, for example to assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. Such studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of innovative techniques, agents, methodologies, models or applications that could have major impact on a field of on the epidemiology of drug abuse.  Applications for R21 awards should be for projects distinct from those supported through the traditional R01 mechanism. Long-term projects, or projects designed to increase knowledge in a well-established area, will not be considered for R21 awards. Applications submitted under the R21 mechanism should be exploratory and novel, and seek to break new ground or extend previous discoveries toward new directions or applications. Researchers are encouraged to utilize existing research infrastructures where possible so that their exploratory/developmental grants will complement, benefit from, and enhance available expertise in such fields as biology, genetics, and sociology.

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 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. Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Times
        A. Submission, 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

This Funding Opportunity Announcement (FOA) issued by the National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH), is intended to support the R21 Exploratory/Developmental research project for early and conceptual research development to advance scientific knowledge about the epidemiology of drug abuse. Such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research. The R21 may involve considerable risk but may lead to breakthroughs in particular areas, or to the development of novel techniques, agents, methodologies, models or applications that could have major impact on such fields as biology, genetics, and sociology, among others. In particular, it encourages the development of innovative scientific partnerships and collaborations that utilize existing research infrastructures, networks, and scientific expertise.

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. It also contributes to our understanding of 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 in the advancement of drug abuse research. Moreover, increased understanding of how genetic, biological, social, and contextual phenomena interact to influence behavior will help to inform prevention and treatment for individuals at risk for drug abuse. Of note, this FOA encourages the development of innovative scientific partnerships and collaborations to enhance the utilization of existing research infrastructures, networks, and scientific expertise.

The NIDA encourages innovative exploratory/developmental (R21) research applications for early stage, novel developmental studies on the epidemiology of drug abuse. In particular, this FOA will support novel exploratory/developmental R21s that seek to advance scientific knowledge and lead to larger research projects capable of utilizing and integrating complementary methodological approaches and disciplines, such as those of, among many others, biology, genetics, and sociology.

This FOA envisions cross-cultural, national and international R21 research projects that cut across numerous other themes and issues in the field of drug abuse research.  Such cross-cutting issues include:

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 such crosscutting issues as gender, HIV/AIDS, health disparities, and methodological innovations apply across all of these topics.  Examples of the types of research topics include those described below; interested applicants are encouraged to review the original PA-04-100 for additional information on these and other research program areas.

o Emerging and current trends

o Social epidemiology of drug abuse

o Familial/genetic liability and phenotypic heterogeneity

o Drug abuse psychopathology: co-morbidity 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.  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 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. 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. In the context of this FOA, R21s are particularly encouraged for novel investigations that may break new ground, extend previous discoveries, or utilize new methodological, statistical, and analytic approaches to model complex disorders and traits.

Drug abuse psychopathology, co-morbidity, 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 co-morbid 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.   

Developmental consequences of drug abuse – This program focuses on the effects of parental drug abuse and its consequences 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 co-morbid 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.

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the NIH Exploratory/Developmental Grant (R21) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project.

This FOA uses just-in-time concepts. It also uses the modular budget formats (see the “Modular Applications and Awards” section of the NIH Grants Policy Statement. Specifically, if you are submitting an application with direct costs in each year of $250,000 or less (excluding consortium Facilities and Administrative [F&A] costs), use the PHS398 Modular Budget component provided in the SF424 (R&R) Application Package and SF424 (R&R) Application Guide (see specifically Section 5.4, “Modular Budget Component,” of the Application Guide).

Exploratory/developmental grant support is for new projects only; competing renewal (formerly “competing continuation”) applications will not be accepted. Up to two resubmissions (formerly “revisions/amendments") of a previously reviewed exploratory/developmental grant application may be submitted. See NOT-OD-03-041, May 7, 2003.  

2. Funds Available

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 the NIH Institutes and Centers (ICs) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 2 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines for an exploratory/developmental project; direct costs are limited to $275,000 over an R21 two-year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year.  The request should be tailored to the needs of the project, with no more than $200,000 in direct costs allowed in any single year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $275,000 for the combined two-year award period. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this Program Announcement funding opportunity.

F&A costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004, November 2, 2004.

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 as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her 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 support.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current NIH Grants Policy Statement.

3. Other-Special Eligibility Criteria

Applicants may submit more than one application, provided each application is scientifically distinct. 

Section IV. Application and Submission Information

Registration and Instructions for Submission via

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Started 

2) Organizational/Institutional Registration in the eRA Commons

3) ) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R &R) application forms and SF424 (R&R) Application Guide for this FOA through

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance contact GrantsInfo, Telephone 301-435-0714, Email:

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
PHS398 Modular Budget

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the NIH R21 uses ONLY the PHS398 Modular Budget. (Do not use the detailed Research & Related Budget.)

Foreign Organizations
Several special provisions apply to applications submitted by foreign organizations:

Proposed research should provide a unique research opportunity not available in the United States.

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review and Anticipated Start Dates

Opening Date: May 2, 2006 (Earliest date an application may be submitted to
Letters of Intent Receipt Date(s): Not Applicable
Application Submission/Receipt Date(s):  Standard dates apply, please see
AIDS Application Submission/Receipt Date(s):  Please see
Peer Review Date(s): Please see
Council Review Date(s): Please see
Earliest Anticipated Start Date(s): See

3.A.1. Letter of Intent

A letter of intent is not required for the funding opportunity.

3.B. Sending an Application to the NIH

To submit an application in response to this FOA, applicants should access this FOA via and follow steps 1-4. Note: Applications must only be submitted electronically.

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and AOR/SO have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note that such an application is considered a "resubmission" for the SF424 (R&R).

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.   

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 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 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 the NIH Grants Policy Statement.

6. Other Submission Requirements

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

Renewal (formerly “competing continuation” or “Type 2”) applications are not permitted.  

All application instructions outlined in the SF424 (R&R) application are to be followed, with the following requirements for R21 applications:

Note: While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.   

Plan for Sharing Research Data

Not Applicable.

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 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.

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

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

2. Review and Selection Process

Applications submitted for this funding opportunity will be assigned to the ICs on the basis of established PHS referral guidelines.

Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures ( will evaluate applications for scientific and technical merit.

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

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

The NIH R21 exploratory/developmental grant is a mechanism for supporting novel scientific ideas or new model systems, tools, or technologies that have the potential to significantly advance our knowledge or the status of health-related research.  Because the Research Plan is limited to 15 pages, an exploratory/developmental grant application need not have extensive background material or preliminary information as one might normally expect in an R01 application.  Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.  Reviewers will place less emphasis on methodological details and certain indicators traditionally used in evaluating the scientific merit of R01 applications, including supportive preliminary data. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.  Preliminary data are not required for R21 applications; however, they may be included if available.   

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 scientific health 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 PD/PI 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 item 6 of the Research Plan component of the SF424 (R&R).

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 item 7 of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under item 11 of the Research Plan component of the SF424 (R&R) 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 and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the percent effort listed for the PD/PI appropriate for the work proposed? Is each budget category realistic and justified in terms of the aims and methods?

3. Anticipated Announcement and Award Dates

Not Applicable.

Section VI. Award Administration Information

1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the NIH eRA Commons.

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 NoA will be generated via email notification from the awarding component to the grantee 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 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 NoA. 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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 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:

YonetteThomas, Ph.D.
Division of Epidemiology, Services, and Prevention Research
National Institute on Drug Abuse, NIH., DHHS
NSC Bldg., Room 5146, MSC 9589
6001 Executive Boulevard 
Bethesda, MD 20892-9589
Telephone: (301) 402-1910
FAX: (301) 443-2636

2. Peer Review Contacts:
Not Applicable.

3. Financial or Grants Management Contacts:

Gary Fleming, J.D.
National Institute on Drug Abuse
6101 Executive Boulevard, Room 250, MSC 8403
Bethesda, MD  20892-8403
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-6710
FAX:  (301) 594-6849

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,

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 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 SF424 (R&R); 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:

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

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