Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH), (http://www.nih.gov)

Components of Participating Organizations     
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)

Title:  Epidemiology of Drug Abuse (R01)

Announcement Type
This is a reissue of PA-04-100, which was previously released on May 3, 2004, and is now divided into separate FOAs for R01, R21, and R01 funding mechanisms. 

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

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

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-07-118

Catalog of Federal Domestic Assistance Number(s)
93.279

Key Dates
Release/Posted Date: December 8, 2006
Opening Date:  January 5, 2007 (Earliest date an application may be submitted to Grants.gov).
Letters of Intent Receipt Date(s): Not applicable.
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s):  Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm  
AIDS Application Submission/Receipt Date(s):  Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS.
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward 
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
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

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. Submitting an Application Electronically 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 Contacts
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), supercedes PA-04-100 and is intended to stimulate innovative investigations, based on the R01 mechanism, that enhance our understanding of: (1) drug use patterns and trends within and across populations; (2) interplay of social interactions, social environment, structural context with individual behavioral characteristics and genetic vulnerability; (3) the phenotypic heterogeneity of drug abuse; (4) causal mechanisms leading to onset, maintenance, and remittance of drug abuse, as well as protective mechanisms that reduce the risk of drug abuse; and (5) drug abuse over the life course, including developmental processes that influence drug use trajectories and behavioral, health, and social consequences of drug abuse. In addition, research is encouraged to develop methodologies to improve the accuracy, efficiency, scope, timeliness, and analytic yield of drug abuse epidemiologic data. Because of the breadth of epidemiology research, applications are anticipated to reflect diverse and multidisciplinary putative approaches and multiple levels of causation. To take advantage of the strength of specific research fields in an efficient manner, and to maximize the generalizability of findings, researchers are encouraged to develop and/or incorporate innovations in epidemiologic study design. Such designs may include nesting of biological and/or basic research, contextual analysis, and contemporary longitudinal analyses. 

Background

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

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

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

Crosscutting Issues

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

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

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

Advances in the field of drug abuse epidemiology will require innovations in statistical, epidemiologic, sociologic, and genetic epidemiologic designs to meet challenges in the rapidly evolving drug abuse field. This announcement encourages methodological innovations that address transitions in stages and trajectories of drug abuse, intergenerational transmission of drug abuse, and heterogeneous pathways to and consequences of drug abuse. Especially encouraged are approaches that facilitate: (a) nested case-control and case- cohort designs that efficiently combine the advantages of epidemiologic samples with more intensive laboratory-based and biological measures, (b) innovations in measurement such as real-time measures of drug abuse through the use of handheld devices, and (c) secondary analyses of existing epidemiologic data sets that contain high-quality information about drug abuse. For more information on research using secondary analyses, particularly research on psychopathology vulnerability for drug abuse, see PA-06-439, Risk Factors For Psychopathology Using Existing Data.

Major Program Areas

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

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

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

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

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

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

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

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

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

Special Considerations:

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 services for persons at risk for HIV infection including injecting drug users, crack cocaine users, and sexually active drug users and their sexual partners.  For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-01-001.html.

National Advisory Council on Drug Abuse Recommended Guidelines for the Administration of Drugs to Human Subjects:  That National Advisory Council on Drug Abuse recognizes the importance of research involving the administration of drugs to human subjects and has developed guidelines relevant to such research.  Potential applicants are encouraged to obtain and review these recommendations of Council before submitting an application that will administer compounds to human subjects.  The guidelines are available on NIDA’s home page at http://www.nida.nih.gov under Funding, or may be obtained by calling (301) 443-2755.

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

Section II. Award Information


1. Mechanism of Support

This FOA will use the NIH Research Project Grant (R01) award mechanism.   

The applicant will be solely responsible for planning, directing, and executing the proposed project.  

This FOA uses “Just-in-Time” information concepts. It also uses the modular as well as the non-modular budget formats (see http://grants.nih.gov/grants/funding/modular/modular.htm).

Specifically, if you are a U.S. organization and 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). 

U.S. applicants requesting more than $250,000 in annual direct costs and all foreign applicants must complete and submit budget requests using the Research & Related Budget component found in the application package for this FOA. See NOT-OD-06-096, August 23, 2006.        

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 ICs provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

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 institution/organization has any of the following characteristics:

1.B. Eligible Individuals

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with his/her organization 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.

More than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach that clearly does not fit the single-PD/PI model.  Additional information on the implementation plans and policies and procedures to formally allow more than one PD/PI on individual research projects is available at http://grants.nih.gov/grants/multi_pi. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application (see http://era.nih.gov/ElectronicReceipt/preparing.htm for instructions).

The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project. Applications for multiple PD/PI grants will require additional information, as outlined in the instructions below. The NIH review criteria for approach, investigators, and environment have been modified to accommodate applications involving either a single PD/PI or multiple PDs/PIs. When considering multiple PDs/PIs, please be aware that the structure and governance of the PD/PI leadership team as well as the knowledge, skills and experience of the individual PD/PIs will be factored into the assessment of the overall scientific merit of the application.  Multiple PDs/PIs on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each PD/PI is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the submission of required reports. For further information on multiple PDs/PIs, please see http://grants.nih.gov/grants/multi_pi.

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


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 http://www.grants.gov/applicants/apply_for_grants.jsp 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 Grants.gov/Get Registered

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.

Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

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 Grants.gov 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 the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

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: GrantsInfo@nih.gov.

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 for this FOA through Grants.gov/Apply.

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 “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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 or Research & Related Budget: Select one, as appropriate (See Section IV.6., “Special Instructions,” regarding appropriate required budget component. Research & Related Budget is required for foreign applications.)  

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

Foreign Organizations (Non-domestic (non-U.S.) Entity)

NIH policies concerning grants to foreign (non-U.S.) organizations can be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part12.htm#_Toc54600260.

Applications from foreign organizations must:

Proposed research should provide special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources.

SPECIAL INSTRUCTIONS  

Applications with Multiple PDs/PIs

When multiple PDs/PIs are proposed, NIH requires one PD/PI to be designated as the "Contact” PI, who will be responsible for all communication between the PDs/PIs and the NIH, for assembling the application materials outlined below, and for coordinating progress reports for the project. The contact PD/PI must meet all eligibility requirements for PD/PI status in the same way as other PDs/PIs, but has no other special roles or responsibilities within the project team beyond those mentioned above.

Information for the Contact PD/PI should be entered in item 15 of the SF424(R&R) Cover component. All other PDs/PIs should be listed in the Research & Related Senior/Key Person component and assigned the project role of “PD/PI.” Please remember that all PDs/PIs must be registered and be assigned the PI role in the eRA Commons prior to application submission. The Commons ID of each PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

All projects proposing Multiple PDs/PIs will be required to include a new section describing the leadership of the project.

Multiple PD/PI Leadership Plan: For applications designating multiple PDs/PIs, a new section of the research plan, entitled “Multiple PD/PI Leadership Plan” (Section 14 of the Research Plan Component in the SF424 (R&R)) must be included. A rationale for choosing a multiple PD/PI approach should be described.  The governance and organizational structure of the leadership team and the research project should be described, including communication plans, process for making decisions on scientific direction, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators. 

If budget allocation is planned, the distribution of resources to specific components of the project or the individual PDs/PIs should be delineated in the Leadership Plan.  In the event of an award, the requested allocations may be reflected in a footnote on the Notice of Award

Applications Involving a Single Institution

When all PDs/PIs are within a single institution, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions 

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component. All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form. See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form. 

When submitting a modular budget, the prime institution completes the PHS398 Modular Budget component only. Information concerning the consortium/subcontract budget is provided in the budget justification. Separate budgets for each consortium/subcontract grantee are not required when using the Modular budget format. See Section 5.4 of the Application Guide for further instruction regarding the use of the PHS398 Modular Budget component.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date:  January 5, 2007 (Earliest date an application may be submitted to Grants.gov).
Application Submission/Receipt Date(s):  Standard dates apply, please see http://grants.nih.gov/grants/funding/submissionschedule.htm
AIDS Application Submission/Receipt Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#AIDS
Peer Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Council Review Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward
Earliest Anticipated Start Date(s): Standard dates apply, please see http://grants1.nih.gov/grants/funding/submissionschedule.htm#reviewandaward

3.A.1. Letter of Intent

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

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov 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 Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (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 Grants.gov and the Commons. The submitting AOR receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status 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 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 or competing renewal (formerly “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 renewal 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

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI(s) 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.

Organizational DUNS

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 Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

PHS398 Research Plan Component Sections

Items 2-5 of the PHS398 Research Plan component are limited to 25 pages. While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component 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.   

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Special Instructions for Modular Grant applications

R01 applications from U.S. institutions/organizations requesting up to $250,000 per year in direct costs (excluding consortium F&A costs) must be submitted in a modular budget format. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm. When submitting a modular budget, the applicant organization will include only the PHS398 Modular Budget component. See Section 5.4 of the SF424 (R&R) Application Guide for further instructions regarding the use of the PHS398 Modular Budget component.

Foreign organizations may not submit modular budgets. See NOT-OD-06-096

Special Instructions for Applications Requesting $500,000 (direct costs) or More Per Year

Applicants requesting $500,000 or more in direct costs for any year (excluding consortium F&A costs) must carry out the following steps:

1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study;

2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and,

3) Include the PHS398 Cover Letter component with the application to identify the staff member and IC who agreed to accept assignment of the application.

This policy applies to all new applications, competing renewal (formerly “competing continuation”) applications, resubmission (formerly “revised/amended”) applications, and revision (formerly “competing supplemental”) applications. See NOT-OD-02-004, October 16, 2001. 

APPENDIX MATERIALS

Stop SignIMPORTANT NOTE: NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review.

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better 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.  

Foreign Applications (Non-domestic (non-U.S.) Entity)

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 Web site, 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.

Applicants requesting more than $500,000 in direct costs in any year of the proposed research must include a plan for sharing research data in their application. The funding organization will be responsible for monitoring the data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

The reasonableness of the data sharing plan or the rationale for not sharing research data may 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 expects that grant 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  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). 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 (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit.

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

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 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?  For applications designating multiple PDs/PIs, is the leadership approach, including the designated roles and responsibilities, governance, and organizational structure, consistent with and justified by the aims of the project and the expertise of each of the PDs/PIs?

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 or methodologies, tools, or technologies for this area?

Investigators: Are the PD/PIs and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator(s) and other researchers? Do the PD/PIs and investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Do(es) the scientific environment(s) 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(s), 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:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate? Are the improvements in the resubmission application appropriate?

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 “Human Subjects Sections” of the PHS398 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 the “Human Subjects Sections” of the PHS398 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, t
he adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R).

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. The priority score should not be affected by the evaluation of the budget.

Applications from Foreign Organizations: Whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions in other countries that are not readily available in the United States or that augment existing U.S. resources will be assessed.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data may 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 funding organization will be responsible for monitoring the data sharing policy. http://grants.nih.gov/grants/policy/data_sharing.

2.D. Sharing Research Resources

NIH policy expects that grant 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  http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600131). 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 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.”

Model Organism Sharing Plan: Reviewers are asked to assess the sharing plan in an administrative note. The sharing plan itself should be discussed after the application is scored. Whether a sharing plan is reasonable can be determined by the reviewers on a case-by-case basis, taking into consideration the organism, the timeline, the applicant's decision to distribute the resource or deposit it in a repository, and other relevant considerations.

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 Contact(s):

Yonette Thomas, Ph.D.
Division of Epidemiology, Prevention, and Services Research
National Institute on Drug Abuse/NIH/DHHS
6001 Executive Boulevard, Room 5185, MSC 9589
Bethesda, MD 20892-9589
Rockville, MD 20852 (for express/courier service)
Telephone: 301-402-1910
Fax: (301) 480-2543
Email: yt38e@nih.gov

2. Peer Review Contact(s):

Not applicable.

3. Financial/Grants Management Contact(s):

Edith Davis
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Room 260
Bethesda, MD 20892
Telephone: 301-443-6710
Fax: 301-594-6849
Email:
Edavis1@nida.nih.gov

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 (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

Human Subjects Protection:
Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). 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, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (http://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies 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 http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. 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 http://grants.nih.gov/grants/policy/model_organism/index.htm). 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. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal 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” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; 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 (http://grants.nih.gov/grants/funding/children/children.htm).

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

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

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) 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 http://publicaccess.nih.gov// 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 (HHS) 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 HHS Office for Civil Rights (OCR).

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles. Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations:
This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 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 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: http://www.lrp.nih.gov/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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