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:  2010 NIDA Translational Avant-Garde Award for Medication Development for Diseases of Addiction (DP1)

Announcement Type
New

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

Request for Applications (RFA) Number: RFA-DA-10-013

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:  June 2, 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):  July 2, 2010
Peer Review Date(s): July 2010 
Council Review Date(s): August 2010
Earliest Anticipated Start Date(s): September 30, 2010 
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: July 3, 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
2. Mechanism of Support
3. Funds Available

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. Receipt, 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 required to submit a two-part 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.

Applications focusing solely on novel target discovery, new animal model generation, development/testing of new human laboratory models or mechanistic studies of the neurobiology of addiction are not eligible for this FOA. 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 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 eligible 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 is not eligible 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 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 eligible 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 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.  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.

For this initiative, it is strongly recommended that trans-disciplinary teams be formed as establishing such partnerships is 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 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 DP1 award mechanism. The Project Director/Principal Investigator (PD/PI) will be solely responsible for planning, directing, and executing the proposed project.  This FOA uses “Just-in-Time” information concepts (see SF424 (R&R) Application Guide). Budgets are not required.

2. Funds Available


$2 million have been set aside in 2010 to provide 2-3 awards, contingent upon the submission of a sufficient number of meritorious applications. Awards will be for up to $500,000 in direct costs each year for five years, plus applicable Facilities and Administrative costs to be determined at the time of award.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

NIH grants policies as described in the PAR-10-095 to be eligible to submit a full application in response to this FOA. Only those investigators whose pre-applications are judged to be the most outstanding will be notified of the opportunity to submit full (DP1) applications under RFA-DA-10-013. The full application (DP1) may not be significantly different from what was proposed in the X02 pre-application Significant differences between the full application (DP1) and the X02 may result in the full application not being reviewed.

Recipients of the Translational Avant-Garde Award (DP1) are required to commit the major portion (at least 51%) of their research time (not their total time, which might also include clinical, teaching, etc. duties in addition to research duties) to activities supported by the award. A statement of this commitment must be included in the current and pending support section. Investigators should not apply if they are unable to commit this amount of effort to the project.

There are no citizenship or residency requirements. 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 Applications. An individual may be named as Principal Investigator on only one application.  There is no limit to the number of applications that an institution may submit.

Number of PDs/PIs.  Only one PD/PI (i.e., no multiple PDs/PIs) may be designated on the application.

Resubmissions. Resubmission applications are not permitted in response to this FOA.

Renewals. Renewals applications are not permitted in response to 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 applicationSeveral 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

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

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

For further assistance, contact GrantsInfo -- Telephone 301-435-0714; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY: (301) 451-5936

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms 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).

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

Optional Components:
PHS398 Cover Letter File
PHS 398 Cover Letter File 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: June 2, 2010 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable
Application Due Date(s): July 2, 2010
Peer Review Date(s): July 2010
Council Review Date(s): August 2010
Earliest Anticipated Start Date(s): September 30, 2010

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 and responsiveness by the IC. Incomplete and/or non-responsive 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

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

Pre-award costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs: 1) are necessary to conduct the project, and 2) would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

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

6. Other Submission Requirements and Information

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.

The application items include all those required for the Avant-Garde Award pre-applications (X02) submitted under PAR-10-095. The contents of these items must be substantially the same as those submitted in the pre-application. In addition, applicants submitting applications in response to this DP1 FOA must arrange to have three letters of reference submitted on their behalf and must submit information on human and vertebrate animal subjects, if applicable.

The following documents must be included in the application:  Abstract, Public Health Relevance Statement, Essay, Biographical Sketch (PD/PI only), List of Current and Pending Research Support, a description of the PD/PI’s most significant research accomplishment, and, if applicable, plans for Protection of Human Subjects from Research Risks and Vertebrate Animal Subjects. All documents must be in PDF format and must comply with page limits shown below.  No additional documents should be uploaded to the application. (See detailed information on each component below)

1.     SF424 (R&R) COVER COMPONENT:

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

Item Number 12.  Proposed Project:  Start date: 09/30/2010; End date: 09/29/2015.

Item Number 15a.  Total Federal Funds Requested:  Enter $2,500,000.

Item Number 15c. Total Federal & Non-Federal Funds:  Enter $2,500,000. (See note below.)

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

Note:  The Budget Request is entered only on Lines 15a and c, as described above.  Funds may be requested for personnel (including co-investigators and collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the five-year total – $2.5 million -- should be entered on Lines 15a and c. Applicable Facilities and Administrative (F&A) costs will be determined at the time of award and should not be included in the budget request.  A detailed budget is not requested and will not be accepted.

2.     R&R Other Project Information Component:

Item Number 1. Are Human Subjects Involved?  If “Yes”, upload Plan for Protection of Human Subjects to Item 12, Other Attachments, on this form.

Item Number 2. Are Vertebrate Animals Used?  If “Yes,” upload Plan for Protection of Vertebrate Animal Subjects to Item 12, Other Attachments, on this form.

Items 7-12 are the same as in the X02 pre-application except for correction of minor typographical errors.

Item Number 7. Project Summary/Abstract:  Attach abstract (not to exceed one page) describing the goals of the project. The abstract must be substantially the same as that submitted in response to PAR-10-XXX. Only minor changes, such as fixing typographical errors, will be allowed. Text only – no figures, animations, or Web links are allowed.

The abstract should contain a brief statement describing how the proposed research project is ready for 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 the Public Health Relevance Statement:  In 2-3 sentences using plain language, concretely describe the Practical Outcome (the endpoint of a practical value that the proposed research would enable), the Discovery Application (a clear vision for future implementation that extends the expected project endpoints), and the Impact (an analysis of the likely project impact on disease and medical practice – “how can patients finally benefit from this?”).

Item Number 9.  Bibliography & References Cited:  Do not use.  Reference citations are not required, but may be included in the essay and would be included in the 5-page limit.

Item Number 10.  Facilities & Other Resources:  Do not use.  Include a brief statement of the facilities to be used for the conduct of the research in the List of Current and Pending Research Support document.

Item Number 11.  Equipment:  Do not use.

Item Number 12.  Other Attachments:   The following three documents must be attached: 1) Specific Aims, 2) Essay (limited to 5 pages); 3) Research Accomplishments and Qualifications (limited to one page, see detailed instructions immediately below). If appropriate, Plans for Protection of Human Subjects and/or Vertebrate Animal Subjects must also be attached.

1) Specific Aims:  The Specific Aims are limited to one page and must be substantially the same as those submitted in the pre-application in response to PAR-10-095.

2) Essay:  The essay must be substantially the same as that submitted in the pre-application (X02) in response to PAR-10-095.  Using a maximum of six 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 the 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.

3) Research Accomplishments and Qualifications: The text must be essentially the same as that submitted in the pre-application (X02) in response to PAR-10-095.  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. 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.

3)  Human/Animal Subjects Plans:  If appropriate, separately attach Plans for Protection of Human Subjects/Vertebrate Animal Subjects.

Note:  Applicants may upload a maximum of four documents in Field 12 of the Other Project Information component as follows: (1) Specific Aims (2) Essay; (3) Research Accomplishments and Qualifications; and, if appropriate, (4) Plan for Protection of Human Subjects/Plan for Protection of Vertebrate Animal Subjects.  Applicants uploading more than two documents to this field may receive a warning stating that the maximum number of documents has been exceeded.  This warning should be ignored as it does not apply to Translational Avant-Garde Award applications.

3.     SF424 (R & R) SENIOR/KEY PERSON PROFILE COMPONENT:

Profile – PD/PI – Attach Biographical Sketch:  Complete items only for Project Director/Principal Investigator(s). Do not submit profiles for other senior/key personnel.  Attach PD/PI’s biographical sketch, two pages maximum, 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 PD/PI 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.

PHS 398 Cover Letter (Optional):

Cover letters should be included only when submitting late applications or Changed/Corrected applications after the submission deadline. Do not submit cover letters for initial submissions or for changed/corrected applications submitted before the submission deadline. The cover letter should contain only the following information:

PD/PI name; Funding Opportunity Title: 2010 NIDA Avant-Garde Award Program (DP1); and an explanation of the reason for the late submission.

(See full instructions for submitting the Cover Letter Component in Section 5.2 of the Application Guide. Note: Items 3 – 6 of the Guide do not apply to Avant-Garde Award applications.)

4.     Letters of Reference:

Letters of reference are an important component of the application. Applicants must arrange to have three (and no more than three) letters of reference submitted on their behalf. Applications that are missing letters of reference may be considered incomplete and may not be reviewed.  Late letters will not be accepted.  Applicants are responsible for monitoring the submission of their letters to ensure that three letters have been submitted prior to the submission deadline.  Applicants are encouraged to check the status of their letters in their Commons accounts.

Letters may be submitted beginning June 2, 2010, and must be submitted no later than 5:00 p.m. (EST) July 2, 2010.

To submit a letter of reference, the referee will need the following information:

Letters of reference are confidential. Applicants will not have access to the letters. E-mail confirmations will be sent to both the applicant and the referee.  The confirmation sent to the applicant will include the referee’s name and the date and time the letter was submitted.  The confirmation sent to the referee will include the referee and applicant’s names, a confirmation number, and the date and time the letter was submitted.  

Note: Since e-mail can be unreliable, it is the applicant’s responsibility to check the status of his/her letters of reference periodically in the Commons.

Applicants are strongly encouraged to send the following to their referees or to send their referees the following link to this information:  (http://nihroadmap.nih.gov/pioneer/LettersofReferenceFormat.aspx).   (Note: referees will not be able to submit letters without this information):

Instructions for Referees:

Letters may be submitted to the Commons at (https://public.era.nih.gov/commons/public/reference/submitReferenceLetter.do?mode=new) beginning June 2, 2010, and must be submitted no later than 5:00 p.m. (EST), July 2, 2010.  Late letters will not be accepted and applications with fewer than three letters may not be reviewed. Letters must be submitted electronically – paper copies will not be accepted.

The applicant’s name should be placed at the top of the letter.  Although signatures are not required, the letter must include a signature block with the referee’s full name, title, institution, and contact information. 

In two pages or less, describe the applicant’s qualities that support the applicant’s claim to be able to advance the development of novel therapy development products for the treatment of diseases of addiction. When possible, give specific examples that illustrate these qualities. Address the likelihood that the applicant will conduct translational research in the proposed research area.

Note:  The letter submission page can be accessed without signing into the Commons, and referees do not need to be registered in the Commons.  Referees must provide the applicant’s Commons User Name (User ID) and the other information below:

REFEREE INFORMATION (the individual providing the letter of reference):

APPLICANT INFORMATION (applicants must send this information to their referees):

E-mail confirmations will be sent to both the applicant and the referee following submission of the letter.  The email confirmation will include a Confirmation Number that will be required only when submitting a revised or changed/corrected letter.  Please print the confirmation email for your records. 

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.

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

Applications that are complete and responsive to this FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NIDA in accordance with NIH peer review procedures (http://grants1.nih.gov/grants/peer/).  Review of applications for this FOA will be conducted by an interview process. Investigators will be interviewed by a panel of distinguished external scientists; interviews will be held late July 2010 in the Washington, D.C. area.  A second level of review will be conducted by the National Advisory Council on Drug Abuse. The Director, NIDA, will make the final selection of awardees based on the evaluations of the interview panel, the recommendations of the Advisory Council, and programmatic considerations. Final selections will be announced publicly, and awards made, by the end of September 2010.

The mission of the NIH is to support science in pursuit of knowledge about the biology and behavior of living systems and to apply that knowledge to extend healthy life and reduce the burdens of illness and disability.  As part of this mission, applications submitted to the NIH for grants or cooperative agreements to support biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system. 

Applications will be evaluated based on the likelihood that each applicant will make meaningful progress toward the development of an innovative small molecule or biologic to address unmet medical needs in the drug addiction treatment field, the absence of alternative funding to pursue this direction, and. In particular, reviewers will evaluate:

The programmatic requirement for a translational project: Is the research project focused in a forward, translational direction and on a course for practical application? Does the research project clearly identify the practical outcomes 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 research project built on a thorough analysis of pre-existing evidence and will the progress already made allow the project to advance along the Translational Path? Does the research project define key steps or milestones on a path from the present level of research knowledge to the practical application? 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?

The suitability for Translational Avant-Garde Award mechanism: Evidence that the proposed project carries high levels of translational need and potential impact.

The following core review criteria will also be used in assessing the merits of the applications.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following five scored review criteria, and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the five review criteria below in the determination of scientific and technical merit, and give a separate score for each.  An application does not need to be strong in all categories to be judged likely to have major scientific impact.  For example, a project that by its nature is not innovative may be essential to advance a field.

Significance.  Does the project address an important problem or a critical barrier to progress in the field?  If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved?  How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does this study address an important problem in medication development for diseases of addiction?

Investigator(s).  Are the PD/PI, collaborators, and other researchers well suited to the project?  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)?  If the project is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation.  Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?  Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense?  Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach.  Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?  Are potential problems, alternative strategies, and benchmarks for success presented?   If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Are the project’s entry and exit points on the Translational path well-defined and justified? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Environment.  Will the scientific environment in which the work will be done contribute to the probability of success?  Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed?  Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? 

Additional Review Criteria

As applicable for the project proposed, reviewers will consider the following additional items in the determination of scientific and technical merit.

Protections for Human Subjects.  For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects  and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children.  When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals.  The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.  For additional information, see http://grants.nih.gov/grants/olaw/VASchecklist.pdf.

Biohazards.  Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Additional Review Considerations 

As applicable for the project proposed, reviewers will address each of the following items, but will not give scores for these items and should not consider them in providing an overall impact/priority score.

Select Agents Research. Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans.  Will be expected if an award is considered likely, or an explanation of why sharing is not possible.

Budget and Period Support.  Evaluate the reasonableness of the overall costs and project duration.

Selection Process

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

3. Anticipated Announcement and Award Dates

Applicants will be notified of their status - whether or not they have been selected for interviews - at the end of April, 2010.   Awardees will be notified in August, 2010, and awards will begin September, 2010. 

Section VI. Award Administration Information


1. Award Notices

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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

2. Administrative and National Policy Requirements

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

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

1. This award provides funding for an application submitted in response to RFA-DA-10-013. This grant should be administered in accordance with the guidelines described in this specific announcement. These guidelines are in addition to the standard “Terms and Conditions” referenced in Section III of this Notice of Grant Award.

2a. When issuing statements, press releases, and other documents describing projects or programs funded as a NIDA Translational Avant-Garde Award, please use the following acknowledgement: "This work was funded by the National Institute on Drug Abuse, National Institutes of Health through the NIDA Translational Avant-Garde Award Program, grant number DP1-DA-10-013.

2b. As indicated in the FOA, awardees are expected to commit at least 51% of their research effort to the project supported by the NIDA Translational Avant-Garde Award.

3. Reporting

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

Awardees will be required to submit a scientific progress report on June 1 of each year describing the progress made under this grant and to submit a final progress report, Final Invention Statement, and Financial Status Report at the end of the budget/project period.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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
National Institute on Drug Abuse
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
6101 Executive Boulevard., MSC 8403
Bethesda, 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/.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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