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:  Pre-Application for the 2010 NIDA Translational Avant-Garde Award for Medication Development for Diseases of Addiction (X02)

Announcement Type
New

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

Program Announcement (PA) Number: PAR-10-095

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 (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.279

Key Dates
Release/Posted Date: January 26, 2010
Opening Date:  February 22, 2010 (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 Due Date(s): March 22, 2010
Peer Review Date(s): May 2010 
Council Review Date(s): Not applicable
Earliest Anticipated Start Date(s): Not applicable
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: March 23, 2010

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(s)
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

The purpose of this funding opportunity is to advance the development of safe and efficacious products (“small molecules” or biologics) for the treatment of disorders of addiction. Clinical indications may include disorders stemming from tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opiate use or abuse.  “Small molecules” are organic compounds with traditional drug-like properties, while “biologics” may include vaccines and recombinant therapeutic proteins. Applications may focus on the treatment of one or various addictive disorders. Applications may also focus on the specific symptoms of the addictive disorder such as withdrawal, craving or relapse. Testing of new formulations of marketed medications that are available for other indications, or new combinations of existing medications, which may be promising candidates for the treatment of diseases of addiction is within the scope of this Translational Avant-Garde Award.

The NIDA Translational Avant-Garde Award complements NIDA’s traditional investigator-initiated grant programs by supporting applications with an emphasis and focus on translation of scientific discoveries into medications. Research on the neurobiology of addiction has identified an increasing number of genetic, cellular and biological targets where therapeutic intervention could benefit patients suffering from the consequences of drug abuse. Translation of these scientific discoveries into therapeutic interventions requires additional deliberate, persistent, and focused commitment and effort. The NIDA Translational Avant-Garde Award brings this level of support and commitment by providing academic and industrial scientists with a unique opportunity to realize the therapeutic potential of their scientific discoveries and to push them one step closer to regulatory approval. Those steps could be taken at any juncture along the drug development path from Lead Optimization/Early Safety up to Phase II Clinical trials.

Through this FOA, NIDA seeks to attract exceptionally talented investigators to the mission of expanding the number and breadth of lead compounds in the pipeline for drug addiction treatment, optimizing these leads, and advancing them to clinical testing.  Subsequent to efforts supported through this FOA, private sector commitment to further development is highly desirable; however, it is recognized that NIH facilitation of further development may be essential.  NIH resources (such as those offered by the NIH RAID Program) and traditional mechanisms of NIDA grant support may be utilized to continue successful projects.  For this reason, applicants will be expected to submit a two-part pre-application describing (1) their research project (Individual Mission Plan) as well as (2) a comprehensive plan for further development beyond their project timeline (Overall Translational Path). Refer to Special Instructions in Section IV of this FOA for details.

Pre-applications focusing solely on novel target discovery, new animal model generation, development/testing of new human laboratory models or mechanistic studies of neurobiology of addiction are not appropriate for the NIDA Translational Avant-Garde Award. Basic science projects, such as exploratory projects of hypothesis testing and exploring novel paradigms, are appropriate for other NIH funding mechanisms, such as the R01. In contrast, applicants for the NIDA Translational Avant-Garde award are expected to have assembled a robust body of background data in the basic science and discovery phases to be poised for transition to the pre-clinical and clinical phases of medication development.  NIDA expressly seeks to promote research projects that are ready for clinical translation and can accelerate the development of new medications. Accordingly, only those applicants who conduct research studies positioned on a stage between late drug Discovery and Phase II Clinical Trials are appropriate to apply.  That is, for “small molecules”, the earliest stage of eligibility for this Award is already having small-molecule compounds with the proof of desired pharmacological activity. For biologics, the profiling of promising product candidates in animal models of drug addiction will be allowed as the earliest starting point.

Research positioned at the following stages are not appropriate for NIDA Translational Avant-Garde Award support:

1.         Pre-Discovery (understanding the underlying neurobiology of drug addiction; basic causes of disease at the level of genes, proteins and cells).

2.         Target Identification and Validation (identifying new targets (individual proteins or cellular pathways) which can potentially interact with and be affected by a drug molecule, and confirming their role in disease in in vitro and in animal models of addiction).

3.         Early Discovery (searches for small-molecule compounds or biologics that act on previously validated targets to alter the disease course; random screening of chemical libraries; medicinal chemistry efforts utilizing Structure-Activity-Relationship studies for the sole purpose of improving the affinity and selectivity of ligands, without regard to measures that are relevant to pharmacokinetic or toxicological properties; development of robust assays to test compounds in high throughput screens).

4.         Phase II clinical efficacy studies of marketed medications in their currently available dosage forms.

5.         Phase III clinical efficacy studies.

Although not intended to be entirely inclusive, the following list of research efforts provides examples of project components that will be appropriate for support under the NIDA Translational Avant-Garde Award program:

The research proposed must fit along a defined research continuum leading to practical applications. It may elect to enter at a specific point within the translational continuum (late Discovery (=Lead Optimization/Early Safety) to Phase II clinical trial), and exit when the project has been developed enough to enable the next stage of testing (for example, completion of preclinical development directly enabling IND filing). Given the lengthy process of treatment development, it is recognized that, during the period of research support under this award, not all projects will develop treatments to the point of enabling clinical efficacy testing; however, substantial progress toward this goal is expected.  Pre-applications must clearly define the planned entry and exit points along the treatment development continuum during the requested period of support, as well as long-term plans for further development.

In summary, the NIDA Translational Avant-Garde Award is meant to support individuals who intend to pursue research directions that are not readily supported by other NIH grant mechanisms. Examples of projects that may be more suitable for the NIDA Translational Avant-Garde Award are those that lack an immediate hypothesis-testing component, such as projects focused on bulk synthesis, dosage formulation, and preclinical or clinical safety testing, and projects that would involve the use of unique, proprietary methods.  For this initiative, it is strongly recommended that trans-disciplinary teams be formed as establishing such partnership is often vital to the translational research process.

Awardees are required to commit the major portion (at least 51%) of their research effort to activities supported by the Translational Avant-Garde Award program. Those who will not be able to meet this requirement should not submit pre-applications.

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 X02 mechanism for submission of pre-applications.  Pre-applications are a first step in applying for a 2010 NIDA Translational Avant-Garde Award. Pre-applications will be reviewed by a group of external reviewers.  Those applicants whose pre-applications are identified as being outstanding (e.g., research projects, which are effectively positioned for translation and are not easily admissible for traditional grant mechanisms, from individuals with specific accomplishments and qualifications in the area of translational research) will be notified of the opportunity to submit full applications under RFA-DA-10-013 (DP1).  The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.

2. Funds Available

All awards will be made under RFA-DA-10-013.  No awards will be made under this FOA.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

The following organizations/institutions are eligible to apply:

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 a pre-application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. Those at early to middle stages of their careers, and women and members of groups underrepresented in biomedical or behavioral research are especially encouraged to apply. Investigators who have not been previously involved in drug abuse research are encouraged to consider the scientific opportunity to contribute to this field. 

DP1 awardees are required to commit the major portion (at least 51%) of their research effort to activities supported by the Avant-Garde Award program.  Those who will not be able to meet this requirement should not submit pre-applications.

Only one PD/PI (i.e., no multiple PDs/PIs) may be designated on the pre-application.  NIH intramural investigators are not eligible for support under this program.

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

Number of Pre-applications. An individual may be named as Principal Investigator on only one pre-application. There is no limit to the number of pre-applications that an institution may submit.

Resubmissions. Resubmission applications are not permitted under this FOA.

Renewals. Renewals applications are not permitted under this FOA.

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, use the “Apply for Grant Electronically” button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application.  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 with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered “on-time” (see 3.C.1 for more information about on-time submission).

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 NIH eRA Commons.

Several additional separate actions are required before an applicant 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 and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential.  Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number.  Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

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. Some fields within the SF424 (R&R) application components, 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
PHS 398 Cover Page Supplement
PHS 398 Research Plan

Optional Components:
PHS 398 Cover Letter File
Note: Cover letters should be submitted only when submitting a Changed/Corrected application after the submission date, and should include an explanation for the late submission.

SPECIAL INSTRUCTIONS

Applications proposing multiple PD/PIs are not allowed.

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date: February 22, 2010 (Earliest date an application may be submitted to Grants.gov) 
Letter of Intent Receipt Date(s): Not applicable
Application Due Date(s):March 22, 2010
Peer Review Date(s): May 2010;
Council Review Date(s): Not applicable
Earliest Anticipated Start Date(s): Not applicable

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.  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.

3.C. Application Processing

3.C.1 Submitting On-Time

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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due date(s) and time, the application may be delayed in the review process or not reviewed. All applications must meet the following criteria to be considered “on-time”:

Please visit http://era.nih.gov/electronicReceipt/app_help.htm for detailed information on what to do if Grants.gov or eRA system issues threaten your ability to submit on time.

Submission to Grants.gov is not the last step – applicants must follow their application through to the eRA Commons to check for errors and warnings and view their assembled application!

3.C.2 Two Day Window to Correct eRA Identified Errors/Warnings

IMPORTANT NOTE! NIH has eliminated the error correction window for due dates of January 25, 2011 and beyond. As of January 25, all corrections must be complete by the due date for an application to be considered on-time. See NOT-OD-10-123.

Once an application package has been successfully submitted through Grants.gov, NIH provides applicants a two day error correction window to correct any eRA identified errors or warnings before a final assembled application is created in the eRA Commons.  The standard error correction window is two (2) business days, beginning the day after the submission deadline and excluding weekends and standard federal holidays.  All errors must be corrected to successfully complete the submission process.  Warnings will not prevent the application from completing the submission process.

Please note that the following caveats apply:

3.C.3 Viewing an Application in the eRA Commons

Once any eRA identified 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 weekdays (Monday – Friday, excluding Federal holidays) to view the assembled application before it automatically moves forward to NIH for further processing.

Upon receipt, applications will be evaluated for completeness by the CSR . Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO 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 the 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

Not applicable.

6. Other Submission Requirements

The following instructions are specific to the Avant-Garde Award X02 pre-applications and are exceptions to the general SF424 instructions.  Pre-applications that do not conform to the specific instructions detailed below will not be reviewed,

NOTE: Letters of reference are not required and will not be accepted with pre-applications.  Reference letters will be required of those applicants submitting full (DP1) applications to RFA-DA-10-013.

All application instructions outlined in the SF 424 (R&R) Application Guide (SF424 Application Guide - Adobe Forms B) are to be followed, incorporating “Just-in-Time” information concepts, with the following exceptions, which are specific requirements for Translational Avant-Garde Award applications. Applications that do not conform to the specific instructions detailed below will not be reviewed.

All of the following must be submitted for the pre-application to be considered complete:

1.     SF424 (R&R) COVER COMPONENT:

Item Number 1. Type of Submission: Must be “Pre-Application”

Item Number 8. Type of Application:  Must be “New”.

Item Number 12.  Proposed Project:  Start date:09/30/2010; End date:09/30/2015.

Item Number 15a.  Total Federal Funds Requested:  Enter $0Item Number 15c. Total Federal & Non-Federal Funds:  Enter $0.

Item Number 15d: Estimated Program Income: Enter $0.

2.     RESEARCH & RELATED PROJECT/PERFORMANCE SITE LOCATIONS. Complete as appropriate.

3.     RESEARCH & RELATED Other Project Information Component:

Item Number 1. Are Human Subjects Involved?  Check “No”. Detailed plans regarding protection of human subjects, inclusion of women and minorities, targeted/planned enrollment, and inclusion of children are not required and should not be submitted with this pre-application.  This information will be required from only those individuals who submit a full application in response to RFA –DA-10-013.

Item Number 2. Are Vertebrate Animals Used? Check “No”. Detailed information regarding the use of vertebrate animals is not required at the time of submission. This information will be required only from those individuals, who submit a full application in response to RFA-DA-10-013

Item Number 7. Project Summary/Abstract:  Attach a one page (maximum) abstract of 300 words or less describing the goals of the project. Text only, in PDF format – no figures, animations, or Web links are allowed.

The abstract should contain a brief statement describing how the proposed research project is ready for clinical translation, how it can accelerate the development of new medications, and how it will have the potential for major practical impact. 

Item Number 8. Project Narrative:  Attach Public Health Relevance Statement in PDF format:  In 2-3 sentences using plain language, concretely describe Practical Outcome (the endpoint of a practical value that the proposed research would enable), Discovery Application (a clear vision for future implementation that extends the expected project endpoints), and Impact (an analysis of the significance of the project impact on disease and medical practice – “how can patients finally benefit from this?”).

Item Number 9.  Bibliography & References Cited:  Do not use. 

Item Number 10.  Facilities & Other Resources:  Do not use.  Item Number 11.  Equipment:  Do not use.

Item Number 12.  Other Attachments (in PDF format):  

Research Accomplishments and Qualifications: Attach a description of no more than one page of the PD/PI’s specific accomplishments and qualifications in the area of translational research (e.g. expertise in developing of innovative small molecules or biologics for the treatment of diseases). Provide concrete evidence of the PD/PI’s ability to successfully oversee the proposed project and to successfully apply the proposed technologies and methodologies. What is expected is a summary of specific and relevant accomplishments, not a list of multiple publications and not background narratives. Publications or similar documents will not be accepted.

4.     RESEARCH & RELATED Senior/Key Person COMPONENT

Profile – PD/PI – Attach Biographical Sketch:  Complete items only for Project Director/Principal Investigator. Do not submit profiles for other senior/key personnel.  Attach PD/PI’s biographical sketch, two pages maximum, PDF format, following the sample format shown in the URL in Section 4.5.2 of the Application Guide, omitting Section C, Research Support.)   No other biographical sketches are to be submitted.

Profile – PD/PI – Attach Current and Pending Support:  Attach a list of Current and Pending Support from all sources, including current year direct costs and percent effort devoted to each project. Use the format shown in Section 3.1.1.8 of the Application Guide. A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of 51% of his/her research effort to the project supported by the Translational Avant-Garde Award.

Profile – Senior Key Person 1:  Do not use.  Submit information only for PD/PI.  Information on collaborators or other key personnel is not required but may be included in the Essay.

Note: Pre-applications found not to comply with the page limit requirements or that contain attachments other than those specified will not be reviewed.

5.     PHS398 COVER PAGE SUPPLEMENT

Item Number 2: Human Subjects: Omit

Item Number 4: Human Embryonic Stem Cells: Enter “yes” or “no” as appropriate.

6.     PHS398 RESEARCH PLAN ATTACHMENTS

Item Number 1. Introduction to Application (for Resubmission or Revision only): Omit

Item Number 2: Specific Aims: Limited to one page.

Item Number 3: Research Strategy: The Research Strategy must consist of a single 6-page document containing the following two elements: 1) Essay (limited to 5 pages); 2) Research Accomplishments and Qualifications (limited to one page, see detailed instructions immediately below).

1) Essay:  Using a maximum of five pages, compose an essay consisting of two key parts: (A) the Overall Translational Path and (B) the Individual Mission Plan. The Overall Translational Path must demonstrate an understanding of the translational process and the research continuum from discoveries to patients. It should also describe how the proposed research fits into the continuum. The Individual Mission Plan must contain a sound research plan specifically indicating how this particular research will contribute to the translational process.  The proposed research must have entry and end points along the Translational Path.  References are not required but, if included, must fit within the 5 page limit.

A) Overall Translational Path: Demonstrate an understanding of the translational process and the research continuum from basic concept to novel therapies for the treatment of diseases of addiction in relation to the proposed research project. Where is project placed along the Overall Translational Path? What is the overall plan for developing the proposed treatment, including the patient population and primary endpoints envisioned for the first clinical efficacy trial?  Include a description of the current status of the intellectual property (IP) protection as well as plans for protection of future IP. Also describe any private sector support for continuation of development beyond the period of the award or plans to seek such support from the public or private sector.

B) Individual Mission Plan: Present a sound research plan specifically indicating how this particular research project will contribute to the translational process. The proposed project must have entry and exit points along the Overall Translational Path.  The Individual Mission Plan should include the following.

References are not required but, if included, must fit within the 5 page essay limit.  Figures and illustrations may be included but must also fit within the 5 page limit.

2) Research Accomplishments and Qualifications: Using a maximum of one page, describe the PD/PI’s specific accomplishments and qualifications in the area of translational research (e.g., expertise in developing innovative small molecules or biologics for the treatment of diseases).  Provide concrete evidence of the PD/PI’s ability to successfully oversee the proposed project and to successfully apply the proposed technologies and methodologies. Expected is a summary of specific and relevant accomplishments, not a list of multiple publications and not background narratives. Publications or similar documents will not be accepted.

Note: Pre-applications found not to comply with the page limit requirements or that contain attachments other than those specified will not be reviewed.

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

The NIH requires the PD(s)/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.”

Appendix Materials 

Appendices are not allowed and will not be accepted.

Resource Sharing Plan(s)

The following resource sharing policies do not apply to this FOA:

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

Review Process

Pre-applications that are complete will be evaluated by a multidisciplinary group of outside experts with expertise in translational research convened by NIDA, who will evaluate the pre-applications based on the criteria listed below.  PIs with the most outstanding pre-applications will be notified of the opportunity to submit full applications for the NIDA Translational Avant-Garde Award (DP1) in response to RFA-DA-10-013. Please note that RFA-DA-10-013 includes additional review criteria of significance, investigator(s), innovation, approach,  and environment.

Using the three review criteria below, reviewers will assess 1) the likelihood that meaningful progress will be made toward the development of an innovative small molecule or biologic to address unmet medical needs in the drug addiction treatment field, 2) that there is an absence of alternative funding to pursue this direction, and 3) that there is compelling justification for needing the NIDA Translational Avant-Garde Award to pursue the stated goals and objectives.

Programmatic Requirements for Translational Research. Does the research project clearly identify the practical outcome of the research efforts? Does the research project represent a significant leap from incremental knowledge-gathering to a practical application (a translational endpoint)? Is the project original? Will it yield meaningful advances in the field of medication development for diseases of addiction? Is the research project built on a thorough analysis of pre-existing evidence and will progress already made allow for advancing the translation process? Are the project’s entry and exit points on the Translational Path well-defined and well-justified? What is the quality of the plans for evaluating the process and outcomes of the translational effort, the probability of success, and the estimated timeframe for development? Does the application acknowledge potential problem areas and consider alternative tactics?

Investigator(s).  Are the PD/PI, collaborators, and other researchers well suited to the project?  That is, is there sufficient evidence of the investigator’s expertise in drug discovery and development and/or translational research, and is there demonstrated ability by the investigator to devote at least 51% of his/her effort to activities supported by this Award? If Early Stage Investigators or New Investigators, do they have appropriate experience and training?  If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? 

The suitability for Translational Avant-Garde Award mechanism: How well has the case been made that the proposed project carries much higher levels of translational need and potential impact than investigator-initiated NIH-supported research projects in basic and clinical sciences?

Additional Review Criteria 

None

3. Anticipated Announcement and Award Dates

Submitting individuals will be notified in late May 2010 whether or not they will be invited to submit full applications in response to the companion RFA-DA-10-013.

Section VI. Award Administration Information


1. Award Notices

Not applicable

2. Administrative and National Policy Requirements

Not applicable

3. Reporting

Not applicable

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 (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Elena Koustova, PhD,
Division of Basic Neuroscience & Behavioral Research
National Institute on Drug Abuse
6001 Executive Boulevard Rm 4282, MSC 9555
Bethesda, MD 20892-9555
Tel:  301-496-8768
Fax: 301-594-6043
E-mail: koustovae@mail.nih.gov

Nora Chiang, PhD
Division of Pharmacotherapies and Medical Consequences of Drug Abuse
Chemistry and Pharmaceutics Branch
6001 Executive Boulevard Rm 4123, MSC 9551
Bethesda, MD 20892-9551
Tel:  301-443-5280
E-mail: nchiang@nih.gov

2. Peer Review Contact(s):

Teri Levitin, Ph.D.
Director, Office of Extramural Affairs
National Institute on Drug Abuse
6101 Executive Boulevard, Suite 220, MSC 8401
Bethesda, MD 20892-8401
Telephone: (301) 443-2755
Fax: (301) 443-0538
Email: tlevitin@mail.nih.gov

3. Financial/Grants Management Contact(s):

Pam Fleming
Grants Management Branch
National Institute on Drug Abuse/NIH/DHHS
6101 Executive Blvd., MSC 8403
Rockville, MD 20892-8403
Telephone: 301-435-1369
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 institutional review board (IRB) rules, as well as local, State and Federal laws and regulations, including the Privacy Rule.

Policy for Genome-Wide Association Studies (GWAS):
NIH is interested in advancing genome-wide association studies (GWAS) to identify common genetic factors that influence health and disease through a centralized GWAS data repository. For the purposes of this policy, a genome-wide association study is defined as any study of genetic variation across the entire human 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. All applications, regardless of the amount requested, proposing 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. Data repository management (submission and access) is governed by the Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies, NIH Guide NOT-OD-07-088. For additional information, see http://grants.nih.gov/grants/gwas/.

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.

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.

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-09-116.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.

NIH Public Access Policy Requirement:
In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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 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. 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/.


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