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: Facilitating Self-Control of Substance Abuse Related Brain Activity Through Real-Time Monitoring of fMRI Signals (R21/R33)

Announcement Type
New

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.

Request For Applications (RFA) Number: RFA-DA-08-020

Catalog of Federal Domestic Assistance Number(s)
93.279

Key Dates
Release/Posted Date: January 10, 2008
Opening Date: February 14, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): February 14, 2008
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):  March 14, 2008
Peer Review Date(s): June 2008 
Council Review Date(s): August 2008
Earliest Anticipated Start Date(s): September 2008
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: March 15, 2008

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. Resource Sharing Plan

3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
    
A. Cooperative Agreement Terms and Conditions of Award
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

Purpose

The purpose of this Funding Opportunity Announcement (FOA) issued by the National Institute on Drug Abuse (NIDA) is to promote investigations that use real-time functional magnetic resonance imaging (rt-fMRI) to enhance the abilities of humans to exert control over activity in specific regions of the brain.  Typically, rt-fMRI uses real-time or near real-time image analysis to present feedback about brain activation patterns, so that subjects can learn to modulate their own brain activity.  The Phased Innovation Award mechanism is used here to encourage methodological and feasibility studies for the implementation and continued development of experimental paradigms, training protocols and brain-computer interfaces for rt-fMRI neuromodulation.  The proposed studies may be conducted in healthy individuals or, if scientifically appropriate, may include substance-abusing populations. All applications, however, must address how the proposed investigations are relevant to the understanding and/or treatment of substance abuse or may be implemented in substance abusing populations.

Because applications are to be exploratory in nature, pilot data that provide support for the proposed hypotheses and aims (i.e., Proof of Concept) are not required, nor is it expected that data to support the hypotheses be provided.  The scientific rationale underlying the studies, however, must be explained and justified.  The focus of the application must be subject self-modulation of cortical and/or subcortical brain regions relevant to substance abuse and dependence in human subjects. Applicants are encouraged to provide evidence that they have the capability to conduct fMRI studies (i.e. Proof of Feasibility) by documenting the availability of needed resources, the training and experience of the investigative team, and/or the conduct of related studies.  While applying investigator teams will be expected to demonstrate expertise in functional MRI methodology (as proof of feasibility), the R21 component of the award may be used for the further transition and adoption of rt-fMRI methodology, including the required brain-computer interface (BCI) and subject training approaches. 

The proposed investigations would be conducted optimally by interdisciplinary teams that include researchers with brain imaging, cognitive neuroscience, and behavioral and treatment expertise although, given the exploratory nature of the projects, it is recognized that not every application will include expertise from all of these disciplines. Applications in response to this FOA may involve multi-institutional collaborations through the use of linked application.   Examples of such collaboration could include, but are not limited to, collaborations between investigators that have real-time fMRI technology and investigators who lack access to such technology, or multi-site validation and standardization of methods and technology. 

Background

This FOA is intended to stimulate research on the use of use real-time functional magnetic resonance imaging (rt-fMRI) to enhance the abilities of humans to exert control over regional brain activity.  In contrast to earlier biofeedback methods, which focused on modulation of indices of autonomic nervous system activity (heart rate, galvanic skin response) or spatially diffuse brain activity (EEG rhythms), rt-fMRI allows the monitoring, and eventual subject modulation, of specific and anatomically defined cortical and subcortical brain regions. For the purposes of this FOA, the term “neuromodulation” will be used to refer to contemporary rt-fMRI methods in order to distinguish it from classical biofeedback methods.

Using fMRI signals from a specific brain region as an independent variable, it has been shown that normal subjects are able to modulate fMRI signals from specific brain regions in real-time.  Subjects can learn to regulate activation in specific regions of the brain in response to real-time feedback of their current brain activation state.  In addition, subjects can also be instrumentally trained to modulate activation by reinforcing changes in region-specific brain activity using secondary rewards (e.g. money or tokens) contingent on successful modulation. Other research has shown that, by using experimenter-specified cognitive strategies, subjects can move cursors in two-dimensional space using region-specific modulation of BOLD signal. These investigations have benefited from incremental advancements in not only general MRI technology, but also from improving brain-computer interfaces (BCI).  Optimized BCI can now perform image reconstruction, motion correction, artifact detection, and presentation of data to subjects within 2-3 seconds of initial data collection.

Neuromodulation using rt-fMRI has been demonstrated recently in several contexts.  For example, subjects can modulate behavioral and emotional responses to pain and emotionally-valenced photographs, motor response cues, lexical stimuli and reward-related stimuli by selectively manipulating fMRI BOLD signal in anterior cingulate cortex, amygdala, insula, precentral gyrus, and Broca’s area and ventral striatum.  Notably, control experiments in which online feedback of BOLD signal is based on activation patterns in irrelevant brain circuitry (or non-contingent feedback) do not alter the behavioral or emotional response.  Thus, rt-fMRI neuromodulation holds therapeutic promise for a variety of disorders if patients can learn to control activity in brain regions that mediate specific symptomology.  For example, using rt-fMRI neuromodulation, chronic pain patients have learned to reduce activity in the anterior cingulate and, as a result, attenuate their pain for a time after training.  Unknown at this point, however, is how long such effects persist and/or whether the outcome is a long-term functional improvement.

Applications in response to this FOA must propose studies that will be conducted in human subjects.  Preclinical studies using only non-human animal subjects or applications that propose only computational models or software or hardware development without human subject studies will be considered unresponsive. Applications may propose the participation of multi-disciplinary teams that include investigators with expertise in cognitive neuroscience, brain imaging, behavioral analysis or treatment research.  Dependent on the role envisioned, members of such teams may serve as principal investigators, co-investigators, collaborators, or outside consultants. Linked applications can be used to facilitate multi-institutional collaborations (for guidance see section IV “Collaborative Arrangements”).

For an application to be deemed responsive, real-time fMRI must serve as an end point for demonstrating successful neuromodulation in human subjects.  The type of imaging acquisition design (e.g., block, event-related, or more sustained acquisition designs) should be matched to the types of stimuli used and the approaches to be explored.  To facilitate training, applications can propose to use measures of non-regional brain activity (e.g., non-localized EEG/ERP), surface brain activity (e.g., optical imaging) or methods where brain activation is inferred, such as cognitive or neuropsychological measures, or brain-mediated but peripherally measured psychophysiological measures (heart rate, galvanic skin response, startle reflex) as intermediate proxy measures.

For the purpose of this FOA, the term "substance abuse" refers broadly to several different but related concepts including substance use (quantity, frequency, patterns, and trajectories) and substance abuse and dependence as defined by diagnostic criteria.  While it is recognized that these concepts may not be interchangeable, the term substance abuse is used for the purposes of fluency.  The term “substance” refers primarily to nicotine, cannabis, cocaine, stimulants, hallucinogens and opiates, but also includes the entire range of licit and illicit substances of potential addiction.

Research Scope

Research Requirements

While the varieties of potential research aims are diverse, all applications must include each of the following:

Examples of areas where research is being sought include, but are not limited to:

Methodological improvement of rt-fMRI technology. This may include investigation of potential advances in different components of the Brain Computer-Interface, including scanner hardware or architecture, novel pulse sequences, artifact minimization tactics, as well as data processing techniques such as pattern recognition. Applications could include proposals to create robust, standardized software modules or hardware add-ons that could be applied to a variety of scanner makes and models to expand the availability of rt-fMRI to clinical practice, and to reduce variability in rt-fMRI data collection and analysis, both within-subjects, between subjects at the same facility, and even between scanning facilities. Applications could address the development of methods to allow rt-fMRI neuromodulation of networks of brain regions as opposed to single brain areas.  To date, rt-fMRI studies have focused on neuromodulation of a single brain region.  However, it is well recognized that most cognitive and behavioral functions involve coordinated networks of activity involving multiple brain regions.  Applications might also focus on the development of methods to use fMRI signals other than the BOLD signals that have been most commonly used to date.  One example would be perfusion fMRI signals, such as arterial spin labeling.  

Characterization and optimization of neuromodulation training techniques.  This could include studies aimed at elucidating optimal subject instruction strategies, behavioral tasks, contextual stimuli, or direct feedback stimuli (including multimodal feedback presentation) to enhance a subject’s control over his or her fMRI signal.  In addition, this may include further discovery and characterization of the cognitive strategies by which subjects can selectively modulate the fMRI signal in targeted regions.

Characterization of variability in rt-fMRI neuromodulationn.  Proposed research could address differential ability to modulate the rt-fMRI signals across subjects or brain regions.  Individual differences in subjects may include neuropsychological, personality or biological characteristics of subjects with high- versus low- self-regulation ability, as well as preliminary comparisons of self-regulation ability between controls and substance abusers. Proposed research could also address systematic characterization of differences in how amenable different brain regions are to rt-fMRI neuromodulation.  The vast majority of successful subject rt-fMRI signal regulation has occurred in cortical surface regions, with less research on subcortical or deeper cortical structures.  Another potential area for investigation is within-subject  longitudinal stability of rt-fMRI signal neuromodulation.  This could include repeated-measures research on the long term ability of individuals to self-regulate fMRI signal both with and without neurofeedback as well as potential contextual cues to promote longer-term maintenance of self-regulation ability.

Use of rt-fMRI neuromodulation approaches to improve brain dysregulation related to substance abuse.  For example, substance use disorder (SUD) is often characterized by craving for drug after exposure to drug-predictive environmental cues, particularly in the presence of a stressor.  fMRI signal change in cortical and subcortical brain regions can be elicited by drug-related cues, where activation by drug-related stimuli has correlated with individual differences in cue-elicited drug craving.  Other examples of dysregulated brain activity that may serve as targets for rt-fMRI neuromodulation may include brain regions involved in inhibitory control of behavior, choice and decision-making, instrumental reinforcement learning and extinction, regulation of body homeostasis or emotionality.

The funding mechanism for this initiative is the Phased Innovation Award.  The initial R21 phase of the award is intended to enable the grantee(s) to demonstrate feasibility and optimization of rt-fMRI techniques or to support development and implementation of rt-fMRI neuromodulation techniques and methods. The R21 phase may also be used to implement transfer of technology and reliability testing of methodology between multiple institutions in linked applications.  Such techniques and methods might range from MRI signal acquisition and signal processing hardware and software to cognitive or behavioral methods for subject instruction and training.  Given the hypothesis-generating nature of the R21/R33 Phased innovation award, only pilot data that demonstrate feasibility of the studies should be included in the application.  All applications must include a proposed timeline of progress for the R21 phase that includes justification for the time needed to complete the R21 phase and specific milestones to be achieved by the end of the R21 funding period.  The R21 phase may be up to a maximum of 2 project years. Given the exploratory nature of the applications, and that the R21 phase allows experienced fMRI investigators to develop rt-fMRI techniques, preliminary data that demonstrate experience with real-time fMRI methodology may be helpful but is not required.

NIDA staff will be responsible for the administrative review of whether the R21 phase milestones specified in the application have been achieved sufficiently to justify award of the R33 component. The studies proposed in the R33 phase may be hypothesis-generating in nature, but not necessarily hypothesis-confirming.  The goal of the proposed studies should be demonstrating feasibility and utility of the new application of rt-fMRI neuromodulation.  It is expected that the conduct of full-scale studies with adequate controls to rule out alternative mechanistic hypotheses would be the subject of subsequent applications.

Since exploratory applications are expected to be descriptive and hypothesis-generating in nature, pilot data that provide support for the proposed hypotheses and aims (i.e., Proof of Concept) are not required, nor should applications be penalized for lacking preliminary data supporting the proposed hypotheses and aims. However, applicants are encouraged to provide evidence that they have the capability to conduct functional MRI studies (i.e. Proof of Feasibility), by documenting the availability of needed resources, the training and experience of the investigator team, and/or the conduct of related studies. The studies proposed in the R33 phase should be hypothesis-generating in nature, and not necessarily hypothesis-confirming.  The goal of such studies should be directed towards demonstrating feasibility and utility of the implementation and use of rt-fMRI rather than completion of a full study.  It is expected that the conduct of full clinical studies with adequate controls to rule out alternative mechanistic hypotheses would be the subject of subsequent applications.

In summary, the current initiative seeks to advance a program of methodological development and/or descriptive, hypothesis-generating research into the use of rt-fMRI neuromodulation in human subjects.  Ultimately, such knowledge may facilitate the translation of rt-fMRI from a research tool to a treatment intervention.

Special Considerations

HIV/AIDS Counseling and Testing Policy for the National Institute on Drug Abuse: In light of recent significant advances in rapid testing for HIV and in effective treatments for HIV, NIDA has revised its 2001 policy on HIV counseling and testing.  NIDA-funded researchers are strongly encouraged to provide and/or refer research subjects to HIV risk reduction education and education about the benefits of HIV treatment, counseling and testing, referral to treatment, and other appropriate interventions to prevent acquisition and transmission of HIV.  This policy applies to all NIDA funded research conducted domestically or internationally.  For more information see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-07-013.html.

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

Section II. Award Information


1. Mechanism of Support

Use of the NIH Phased Innovation (R21/R33) Grant Award

This Funding Opportunity Announcement (FOA) will use the R21/R33 Phased Innovation Award mechanism, with the potential for conversion to the R33 mechanism. The NIH Phased Innovation (R21/R33) grant award is being used to permit an investigator to perform initial developmental work in the R21 phase (i.e., Phase I), to demonstrate feasibility by meeting a set of quantitative, peer-reviewed milestones, and then to move directly into more extensive study in the R33 phase (i.e., Phase II).

The combined R21/R33 Phased Innovation Award application offers the following two advantages over the regular application process:

Single submission and peer review of both the R21 and R33 Phases in one application; and

Minimal or no funding gap between the R21 and R33 phases. The award of R33 funds will be based on program priorities, on the availability of funds and on successful completion of Phase 1 aims, including negotiated Milestones (Objective Performance Targets), as determined by NIDA staff in the context of peer review recommendations.

To be eligible for the Phased Innovation Award, the R21 phase must include well-defined, objective, and preferably quantifiable performance targets (Milestones) useful for judging the success of the proposed research, as well as a credible plan for the studies in the R33 phase. The Research Design and Methods section of the Phased Innovation Award application must have a section labeled “Estimated R21 Progress Milestones” at the end of the R21 section of the Research Plan (See section VI part 6, below). This section must include well-defined, objective (quantitative if possible) performance targets (Milestones) for completion of the R21 Phase part of the application, a discussion of the suitability of the proposed Milestones for assessing success of the R21 phase work, and a discussion of the implications of successful completion of these Milestones for the proposed R33 study. Transition of the R21 to the R33 phase will be expedited and is dependent on the completion of negotiated milestones.

This FOA uses just-in-time concepts. It also uses the non-modular budgeting formats. Full budget presentations and justifications are required. Follow the instructions fornon-modularbudget research grant applications. Applicants must complete and submit budget request using the SF424 Research and Related (R&R) Budget component found in the application package. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm.

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

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.

All applications must be new applications.  No Renewal or Revision applications will be accepted.

2. Funds Available

NIDA intends to commit approximately $3 million dollars in FY2008 to fund 6-10 applications. Direct costs for individual applications are limited to $200,000 per year for the R21 phase and $400,000 per year for the R33 phase.  These budget limits also apply to the individual submissions comprising linked applications.  The amount of funds requested and the distribution of funds across linked applications should be tailored to the needs of the project.  The R21 phase can be up to two years, and the R33 phase can be up to 3 years. 

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.

Facilities and Administrative (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 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 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

All applications must be new applications.  No renewal or revision applications will be allowed.

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

General Characteristics of Responsive Applications

In order to be judged responsive, applications submitted under this FOA must:

1) proposed studies to be conducted in human subjects, but not necessarily in subjects who are current or past users of drugs of abuse;

2) propose studies throat use real-time fMRI as an end point for demonstration of successful neuromodulation by human subjects.  The type of imaging acquisition design (e.g., block, event-related, or more sustained acquisition designs) should be matched to the types of stimuli used and the hypotheses to be tested.  Applications can use measures of non-regional brain activity (e.g., non-localized EEG/ERP), surface brain activity (e.g., optical imaging), or methods where brain activation is inferred, such as cognitive or neuropsychological measures or brain mediated but peripherally measured psychophysiological measures (heart rate, galvanic skin response, startle reflex) as intermediate proxy measures to facilitate training. Applications that only incorporate physiological methods not tied to the activity of specific brain regions by rt fMRI(e.g., non-localized EEG/ERP, peripheral psychophysiological measures) are not responsive, but such measures can be used in conjunction with a regional brain imaging technique;

3) provide a justification of how the brain region selected for modulation relates to substance use disorder. 

Applicants are strongly encouraged to contact program staff with any questions regarding the responsiveness of their proposed project to the goals of this RFA. 

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/Apply/ 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 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.

Both the PD/PI 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 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 is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY 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
Research & Related Budget

PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist 

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/R33__ uses ONLY the detailed Research & Related Budget. (Do not use the PHS398 Modular Budget.)

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 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 PHS398 Research Plan component), must be included. The governance and organizational structure of the research project should be described, including communication plans, process for making decisions on scientific direction, allocation of resources, publications, intellectual property issues, 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, including responsibilities for human subjects or animal studies as appropriate.

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.

Unlinked Collaborative Applications 

When collaborations across multiple institutions are proposed in a single, unlinked application, 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.  Note that unlinked applications featuring collaborations will still be subject to the budget limit of $200,000 per year for the R21 phase, and $400,000 per year for the R33 phase.

 Information concerning the consortium/subcontract budget is provided in the budget justification.

Linked Collaborative Applications

Direct costs for collaborative applications are limited to $200,000 per year for the each individual application in the R21 phase and $400,000 per year for each individual application in the R33 phase,  The budget of each individual linked application will be expected to reflect that institution’s contribution to a given collaboration.

Collaborative applications must incorporate the following items in the application from each of the clustered institutions:

1) A common base title plus a tag denoting the linkage of the form “1/N in the Title field, e.g. “1/6 – Multisite Investigation of”.  Titles need to be succinct so that they do not exceed 80 characters.

2) A cover letter that lists all of the collaborative applications with the PD/PI name, Title (including the tag) and Applicant Institution.  The list must be identical for all of the collaborative applications.

3) An attachment to each application that lists all of the collaborative applications.  The list must be included in Item 11. Other Attachments in the Other Project Information Component.  The list must be the same in format and content as in the cover letter and must be the same in each of the collaborating applications.   In the body of the text, the section must begin with the heading “Collaborative Applications”.  When saving the file, it must be named “Collaborative Applications” as well to ensure the application is bookmarked properly.

4) The specific aims portion of a linked application should stress the contribution of the applicant’s institution to the global collaboration, such as subject recruitment and characterization, or conducting training sessions, for example.  It is anticipated that linked applications will share some language pertaining to the global research plan and experimental goal of the collaboration as a whole.

3. Submission Dates and Times

See Section IV.3.A for details.

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

Opening Date: February 14, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): February 14, 2008
Application Submission/Receipt Date(s): March 14, 2008
Peer Review Date(s): June 2008
Council Review Date(s): August 2008
Earliest Anticipated Start Date(s): September 2008  

3.A.1. Letter of Intent

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

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

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

DA-08-020
Director, Office of Extramural Affairs
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD  20892-8401
Rockville, MD  20852 (for express/courier service)
Telephone:  (301) 443-2755
FAX:  (301) 443-0538
Email:  tlevitin@mail.nih.gov

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. 

In order to expedite the review, applicants are requested to notify the NIDA Referral Office by email (tlevitin@mail.nih.gov) when the application has been submitted.  Please include the FOA number and title, PD/PI name, and title of the application.

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. 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 funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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.

Prior to funding an application, the NIDA Program Official will contact the applicant to discuss the proposed milestones and any changes suggested by the review panel as indicated in the Summary Statement. The Program Official and the applicant will negotiate and agree on a final set of milestones. These will be the basis for judging the success of the R21 work. At least one interim progress report will be required during the R21 phase.

For funded applications, completion of the R21 milestones will elicit an expedited review by NIDA staff that will determine whether or not the R33 grant should be awarded. The release of R33 funds will be based on successful completion of negotiated scientific milestones, program priorities, and on the availability of funds. The expedited transitional review may result in additional negotiations of award.

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.

Total Direct costs for individual applications are limited to $200,000 per year for the R21 phase and $400,000 per year for the R33 phase.  Total Direct costs for linked collaborative applications are limited to $200,000 per year for the each individual application in the R21 phase and $400,000 per year for each individual application in the R33 phase.  The budget of each individual linked application will be expected to reflect that institution’s contribution to a given collaboration.

Modular Budget concept will not be used.  Even though there are upper limits on the budget of both the R21 and R33 phases, use the detailed SF424 RR budget forms for all years.  Indicate in the budget justification whether the budget year is for the R21 or R33 phase. 

6. Other Submission Requirements

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

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 Grants.gov. For additional information, see “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

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.”

Research Plan Component Sections

There should be a single Research Plan.  Within the individual sections, describe the R21 and R33 phases as appropriate, but there it is not necessary to repeat background information or details of methods in the R33 section that were provided in the R21 section. Item 2 (Specific Aims) must provide separate sets of aims for the R21 and R33 phases.  Item 5 (Research Design and Methods) must provide separate descriptions of the R21 and R33 phases.

Preliminary Data: The R21 component of an R21/R33 application will be considered exploratory, so that extensive preliminary data from the applicant’s own laboratory are not required. However, the project must be based on a strong rationale, and the applicant should provide evidence that the proposed approach and methods are feasible. The R21 phase provides time for necessary preliminary work such as, for example, the substantial modification of approaches, methods and technology. Although preliminary data are not required for an R21/R33 application, they may be included.

The “Research Design and Methods” section of the application is expected to feature clear sub-headings demarcating the R21 and R33 portions of the proposal. The first component must be the research plan for the R21 stage of the proposal.  The R21 research plan must then be followed by a section entitled “Estimated R21 Progress Milestones.” This section must include specific estimates of expected progress in data collection and/or methods development during the R21 phase, expressed in terms of elapsed months from time of award (up to 24 months), a discussion of the suitability of the proposed progress milestones for assessing success in the R21 phase, and a discussion of the implications of successful completion of these milestones for the proposed R33 study. Milestones should be specific, quantifiable and scientifically justified; they should not be simply a restatement of the R21 specific aims.  

The second component of the research plan must be the research plan for the R33 stage of the proposal.  The R33 phase of the study must be described in sufficient detail to permit reviewers to assess the significance and innovation of the proposed work and the strength of the experimental design. For the R33 phase, Item 5 of the Research Plan should include a statistical section that discusses the choice of the study design and laboratory methods. A method for determining sample sizes for the R33 phase using power calculations based on the outcome of the R21 phase must be clearly stated.

Applicants are encouraged to include all information required for adequate evaluation for reviewers. However, in the event that a technology is not yet patent protected and the applicant does not wish to include complete details, the application should at a minimum provide a demonstration of the capabilities of the proposed approach.

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.

Appendix Materials

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. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

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

6. Other Submission Requirements

Resource Sharing Plan(s)

NIH considers the sharing of unique research resources developed through NIH-sponsored research an important means to enhance the value and further the advancement of the research. When resources have been developed with NIH funds and the associated research findings published or provided to NIH, it is important that they be made readily available for research purposes to qualified individuals within the scientific community. If the final data/resources are not amenable to sharing, this must be explained in the application. See http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm.

(a) Data Sharing Plan: Investigators seeking $500,000 or more in direct costs in any year are expected to include a brief 1-paragraph description of how final research data will be shared, or explain why data-sharing is not possible. Applicants are encouraged to discuss data-sharing plans with their program contact. See Data-Sharing Policy or http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html.

(b) Sharing Model Organisms: Regardless of the amount requested, all applications where the development of model organisms is anticipated are expected to include a description of a specific plan for sharing and distributing unique model organisms or state appropriate reasons why such sharing is restricted or not possible. See Sharing Model Organisms Policy, and NIH Guide NOT-OD-04-042.

(c) Genome Wide Association Studies (GWAS): Regardless of the amount requested, applicants seeking funding for a genome-wide association study are expected to provide a plan for submission of GWAS data to the NIH-designated GWAS data repository, or provide an appropriate explanation why submission to the repository is not possible.  GWAS is defined as any study of genetic variation across the entire genome that is designed to identify genetic associations with observable traits (such as blood pressure or weight) or the presence or absence of a disease or condition.  For further information see Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088, and http://grants.nih.gov/grants/gwas/.

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 that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA in accordance with the standard NIH peer review procedures (http://cms.csr.nih.gov/ResourcesforApplicants/ ) and the review criteria stated below.

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

Award of the R33 phase will be contingent on achievement of the milestones specified in the R21 phase of the application. NIDA staff will be responsible for the administrative review of whether the milestones have been achieved sufficiently to justify award of the R33 component.   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.

Special R21/R33 Criteria

Since exploratory applications are expected to be descriptive and hypothesis-generating in nature, pilot data that provide support for the proposed hypotheses and aims (i.e., Proof of Concept) are not required, nor should applications be penalized for lacking preliminary data supporting the proposed hypotheses and aims. However, applicants are encouraged to provide evidence that they have the capability to conduct functional MRI studies (i.e. Proof of Feasibility), by documenting the availability of needed resources, the training and experience of the investigator team, and/or the conduct of related studies. The studies proposed in the R33 phase should be hypothesis-generating in nature, and not necessarily hypothesis-confirming.  The goal of such studies should be directed towards demonstrating feasibility and utility of the implementation and use of rt-fMRI rather than completion of a full study.  It is expected that the conduct of full clinical studies with adequate controls to rule out alternative mechanistic hypotheses would be the subject of subsequent applications.

Note that the scientific merit and feasibility of both the R21 and R33 components will be jointly evaluated by the scientific review committee, and applications scored accordingly. 

Program staff will only evaluate progress of the R21 component relative to progress milestones stated in the Research Plan of the application.

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?  Emphasis should be placed on the novelty and innovation of the use of rt-fMRI neuromodulation.

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 (or do the applicants) propose realistic time-frame for methodological or data collection progress under the R21 component of the research plan?  Does the applicant acknowledge potential problem areas and consider alternative tactics? Does the applicant (or do the applicants) propose a realistic time-frame for methodological or data-collection progress under the R21 component of the research plan?  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 clinical 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?  Emphasis should be placed on the novelty and innovation of the use of rt-fMRI neuromodulation.

Investigators: Are the PD/PI(s) and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the PD/PI(s) and investigative team bring complementary and integrated expertise to the project (if applicable)?    Linked applications will be considered and reviewed in tandem, such that this criterion will be evaluated by considering the expertise of the complete team of investigators across the linked applications.

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, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?  Linked applications will be considered and reviewed in tandem, such that this criterion will be evaluated by considering the combined facilities and institutional support across the linked applications.

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:.  Applications proposing non-human research will be considered non-competitive.

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. 

Milestones:  How appropriate are the proposed milestones to judge the success of the proposed R21 project and to determine whether the R33 grant should be awarded? Do they set forth specific criteria, in sufficient detail that will permit a straightforward decision about whether or not they have been accomplished? Do the milestones establish feasibility for all aspects of the proposed R33 work?

For the R21/R33 Phased Innovation Award Application, the initial review group will evaluate the specific goals for each phase and the feasibility milestones that would justify expansion to the R33 phase. A single priority score will be assigned to each scored application. The initial review group has the option of recommending support for the R21 portion only,  basing the final merit rating on the recommended portion of the application solely, and articulating concerns related to the application's specific goals and the feasibility milestones justifying expansion to the R33 phase. The recommendation by the review panel to delete the R33 phase or presentation of inadequate milestones in the application may affect the merit rating of the application.

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.B. Additional Review Considerations

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

2.C. Resource Sharing Plan    

When relevant, reviewers will be instructed to comment on the reasonableness of the following Resource Sharing Plans, or the rationale for not sharing the following types of resources. However, reviewers will not factor the proposed resource sharing plan(s) into the determination of scientific merit or priority score, unless noted otherwise. Program staff within the Institute or Center will be responsible for monitoring the resource sharing.

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/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:

James Bjork, Ph.D.
Clinical Neuroscience Branch
Division of Clinical Neuroscience and Behavioral Research
6001 Executive Blvd, Rm.3151
Bethesda, MD 20892-9593
Ph: 301-443-4877
Fax: 301-443-6814
E-mail: jbjork@nida.nih.gov

2. Peer Review Contacts:

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

3. Financial or Grants Management Contacts:
.
Pam Fleming
Chief, Grants Management Branch
National Institute on Drug Abuse/NIH/DHSS
6001 Executive Blvd., MSC 9541
Rockville, MD  20892-9541
Telephone:  301-443-6710
Fax:  301-594-6849
Email: pfleming@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) must be used for publicly accessible on-line journal articles.  Unless otherwise specified in this solicitation, Internet addresses (URLs) should not be used to provide any other information necessary for 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 FOA 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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