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:  2008 NIDA Avant-Garde Award Program for HIV/AIDS Research (DP1)

Announcement Type
New

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

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

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

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

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

Request for Applications (RFA) Number: RFA-DA-08-003

Catalog of Federal Domestic Assistance Number(s)
93.279

Key Dates
Release/Posted Date: November 9, 2007
Opening Date: February 26, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s):  March 26, 2008
LETTERS of REFERENCE Submission/Receipt Date(s): March 26, 2008, 5:00 p.m. (EST).
Peer Review Date(s): May 2008 
Council Review Date(s): August 2008
Earliest Anticipated Start Date(s): September 2008
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: March 27, 2008

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

The NIDA Director’s Avant-Garde Award Program for AIDS research is meant to complement NIDA’s traditional investigator-initiated grant programs by supporting individual scientists of exceptional creativity who propose approaches in the forefront of drug abuse and HIV/AIDS research.

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives


Section II. Award Information

1. Mechanism of Support

2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information

2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
          1. Letter of Intent
    B. Submitting an Application Electronically to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

This award is designed to support individual scientists of exceptional creativity who propose cutting edge – and possibly transformative - approaches to major challenges in biomedical and behavioral research on drug abuse and HIV/AIDS. The term “avant-garde” is used to describe highly innovative approaches that have the potential to produce an unusually high impact. The proposed research should reflect ideas substantially different from those already being pursued by the investigator or others. Biomedical and behavioral research is defined broadly in this announcement as encompassing scientific investigations in the biological, behavioral, clinical, social, physical, chemical, computational, engineering, and mathematical sciences. The award is meant to support individuals who intend to pursue new research directions that are not readily supported by other NIH grant mechanisms. The program is not intended simply to expand the funding of an already supported research project, but rather to support highly creative researchers to pursue innovative concepts.and approaches to research on drug abuse and HIV/AIDS.

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

Section II. Award Information


1. Mechanism of Support

This Funding Opportunity Announcement (FOA) will use the NIH Research Project Grant (DP1) award mechanism.   

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

2. Funds Available

Sufficient funds have been set aside in 2008 to provide 2-3 awards.  The awards will be for $500,000 in direct costs each year for five years.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions
 
You may submit an application(s) if your institution/organization has any of the following characteristics:

Non-domestic (non-U.S.) entities (Foreign Organizations) are not eligible to apply.

1.B. Eligible Individuals

Investigators at all career levels are eligible. 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.  We also encourage investigators who have not been previously involved in drug abuse research to consider the scientific opportunity to contribute to this field.  There are no citizenship or residency requirements.

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
The research proposed need not be in a conventional biomedical or behavioral discipline; if the individual's experience is in non-biological areas, however, he/she must demonstrate a commitment to exploring topics of biomedical or behavioral relevance to HIV/AIDS.  This initiative is to support new research directions, and individuals may not request funds to expand currently funded research. If selected, individuals must show evidence of institutional infrastructure support. Awardees are required to commit the major portion (at least 51%) of their research effort to activities supported by the program.

Applicants may submit only one application as a PD/PI in response to this FOA.

There is no limit to the number of applications that institutions may submit.    

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/applicants/apply_for_grants.jsp and follow the directions provided on that Web site.

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

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

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

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

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

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

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

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

1. Request Application Information

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

After clicking “Apply for Grant Electronically,” applicants will be presented with a list of six application packages corresponding to six scientific areas, as described in the Special Instructions in Section 2 below. (The selection of scientific area by applicants is solely to aid in selection of the most appropriate group of peer reviewers. The application requirements and instructions below are identical for all six packages. All six scientific areas are considered as a single competition, are reviewed in the same time period, and compete for a single source of funds.)

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

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

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

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

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

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Other Project Information Component
Research & Related Senior/Key Person Profile Component

Optional Components:
PHS398 Cover Letter File (Note:  Cover letters should be included ONLY when submitting late applications. 

When submitting a Changed/Corrected Application after the submission date, a cover letter is required explaining the reason for the Changed/Corrected Application. If you already submitted a cover letter with a previous submission and are now submitting a Changed/Corrected Application, you must include all previous cover letter text in the revised cover letter attachment. The system does not retain any previously submitted cover letters therefore, you must repeat all information previously submitted in the cover letter as well as any additional information. Cover letters are not required when submitting changed/corrected applications before the receipt deadline.

SPECIAL INSTRUCTIONS  

The Commons ID of the PD/PI must be included in the “Credential” field of the Research & Related Senior/Key Person component. Failure to include this data field will cause the application to be rejected.

Applications proposing multiple PIs are not allowed.

The application to be submitted to Grants.gov must include:

Area of Science Selection:   In order to assist NIH staff in assigning applications to the most appropriate reviewers, applicants will designate their area of science by choosing one of six application packages in Grants.gov.  After clicking “Apply for Grant Electronically,” applicants will be presented with a list of six application packages, each with a separate Competition ID and Title.  Each application package corresponds to one of the science areas listed below. 

Areas of Science: Applicants must choose a research area from the following list taken from the Trans-NIH Plan for HIV-Related Research:

Foundational Research

(01) Natural History and Epidemiology
(02) Etiology and Pathogenesis

Prevention Research

(03) Microbicides
(04) Vaccines
(05) Behavioral and Social Science

Therapeutics

(06) Therapeutics

Effort Commitment:  Awardees are required to commit the major portion (at least 51%) of their research effort to activities supported by this announcement.  In their list of current and pending support, applicants must include a statement in the biographical sketch that, if chosen to receive an award, the applicant will commit a minimum of 51% of his/her their research efforts to this award activity

An abstract of no more than 300 words and no more than one page describing the goals of the project.  This document is uploaded on the Research & Related Other Project Information Component form, Item 6.)

An essay of 3-5 pages that addresses the investigator's innovative vision for, and the significance of, the HIV/AIDS biomedical or behavioral problem to be addressed, and his/her qualifications to engage in groundbreaking research. The essay should describe the individual's view of the major challenges in biomedical or behavioral research in HIV/AIDS and drug abuse to which he/she can make seminal contributions. No detailed scientific plan should be provided since the research plan is expected to evolve during the tenure of the grant. The essay should include the following sections within the 3-5 page limit:

How the planned research differs from your past or current work: Describe how the project represents a new and distinct direction for your research.

A two-page biographical sketch for the PD/PI only.  (Use the sample format in the URL in Section 4.5.2 of the Application Guide, omitting Section C, Research Support.)  This document is uploaded on the Research & Related Senior/Key Person Component form, Item 7.  No other biographical sketches are to be submitted.

Special requirements for completing the SF424 (R&R) application are in Section IV.6, below.

The Budget request is entered only on Line 16a and b, as described in Section IV.6, below. Awards are for $2.5 million in direct costs for the five-year budget/project period. Funds may be requested for personnel (including collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the five-year total – $2.5 million -- should be entered on Line 16a and b. A detailed budget is not requested and will not be accepted.

No other documentation, such as letters of collaboration or biographical sketches of other personnel will be accepted. Information about personnel other than the PD/PI is not required, but may be included within the 3-5-page essay.

Format specifications for Text (PDF) Attachments: All attachments must be in PDF format. Follow format specifications for PDF attachments in the Application Guide (http://grants.nih.gov/grants/funding/424/SF424_RR_Guide_General_Ver2.pdf

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: February 26, 2008 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): Not applicable.
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Submission/Receipt Date(s):  March 26, 2008
LETTERS of REFERENCE Submission/Receipt Dates: March 26, 2008, 5:00 p.m. (EST).
Peer Review Date(s): May 2008 
Council Review Date(s): August 2008
Earliest Anticipated Start Date(s): September 2008

3.A.1. Letter of Intent

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

3.B. Submitting an Application Electronically to the NIH

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

3.C. Application Processing

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

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness and eligibility by NIDA staff. Incomplete and 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 receives the Grants.gov acknowledgments. The AOR and the PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

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.

6. Other Submission Requirements

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

The NIH requires the PD/PI(s) to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

Research Plan Component Sections

Not applicable.

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

1.  SF424 (R&R) (COVER COMPONENT):

Item Number and Title

Instructions

8.  Type of Application

Must be “New”

13.  Proposed Project

Enter start date: 09/30/2008; Enter end date: 09/29/2013.

16.  Estimated Project Funding
    a.  Total Estimated Project Funding

Enter $2,500,000

    b.  Total Federal & Non-Federal Funds

Enter $2,500,000

2.  RESEARCH & RELATED OTHER PROJECT INFORMATION COMPONENT:

Item Number and Title

Instructions

1.  Are Human Subjects Involved?

Follow the Application Guide instructions for all fields in Section 1.a.  Check “Yes” or “No” as appropriate.  If “Yes”, enter “None,” or the IRB Approval Date, Exemption Number, and Human Subject Assurance Numbers may be entered but are not required at the time of submission.  Detailed plans regarding protection of human subjects, inclusion of women and minorities, targeted/planned enrollment, and inclusion of children are not required at the time of submission.  This information will be requested on a just-in-time basis at the time of award. 

2.  Are Vertebrate Animals Used?

Follow the Application Guide instructions for all fields in 2.a.  Check “Yes” or “No” as appropriate. Enter “None.” Detailed plans regarding the use of vertebrate animals are not required at the time of submission.  The IACUC Approval Date and Animal Welfare Assurance Numbers may be entered but are not required at the time of submission.  This information will be requested on a just-in-time basis at the time of award. 

6.  Project Summary/Abstract

Attach abstract.  (Maximum of 300 words and no more than one page; PDF format).

7.  Project Narrative

Attach essay (Maximum of five-pages; PDF format).

8.  Bibliography & References Cited

Do not use.  If you choose to include references, they must be included in the essay, subject to the 5-page limit.

9.  Facilities & Other Resources

Do not use.

10.  Equipment

Do not use.

11.  Other Attachments

Attach description of your most significant research accomplishment (one page maximum, PDF format).

Note: Applications found not to comply with the page limit requirements or that contain attachments other than those specified will be rejected during the agency validation process.

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

Complete items only for Project Director/Principal Investigator.  Do not submit profiles for other senior/key personnel.

Item Title

Instructions

Profile- PD/PI - Attach Biographical Sketch

Attach biographical sketch here (two-page maximum, PDF format).  Use the format shown on page I-58 of the Application Guide, omitting Section C, Research Support (see below).Be sure to include statement indicating your citizenship status.

Profile- PD/PI - Attach Current & Pending Support

Attach a list of Current and Pending Support here (PDF format).  Use the format shown on pages 3.1.1.8 of the Application Guide. Be sure to include statement affirming that you will devote at least 51% of research effort to Avant-Garde Award project.

Profile – Senior Key Person 1

Do not use. Submit information only for PD/PI.  Information on collaborators may be included in the essay.

Note: Applications found not to comply with the page limit requirements will be rejected during the agency validation process.

4.  PHS 398 Cover Letter File (Optional):

Cover letters should be included only when submitting Changed/Corrected applications.  Do not submit cover letters for initial submissions.  The cover letter should contain only the following information:

1.  PD/PI name

2.  Funding Opportunity Title:  2008 NIDA’s Avant-Garde Award Program for HIV/AIDS Research (DP1)

3.  For Changed/Corrected Applications after the submission deadline, include an explanation of the reason for the Changed/Corrected Application.

(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.)

Letters of Reference:

Letters of reference are an important component of the Avant-Garde Award 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 non-responsive 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 can check the status of their letters in their Commons accounts.

Letters may be submitted beginning February 26, 2008, and must be submitted no later than 5:00 p.m. (EST) March 26, 2008.

Applicants must provide the following to their referees (Note: referees will not be able to submit letters without this information):

Funding Opportunity Number (FOA) for this announcement RFA-DA-08-003;

The applicant’s Commons User Name (Note:  Referees do not have to be registered in the Commons and do not need their own Commons User Name – only the Commons User Name of the applicant is required);

The applicant’s first and last name (note – the name must match exactly the applicant’s name in the Commons);

The URL to the letter submission page (https://commons.era.nih.gov/commons/);

The letter of reference submission dates – February 26, 2008 - 5:00 p.m. (EST) March 26, 2008.

Applicants are encouraged to forward the instructions below to their referees or to direct their referees to the following web page that includes the instructions (http://drugabuse.gov/avgp.html).

Confirmations will be sent by email 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.  

Letters of reference are confidential. Applicants will not have access to the letters.

Note: Since email 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 encouraged to send the following instructions to their referees:

Instructions for Referees:

Letters may be submitted to the Commons at (URL) beginning February 26, 2008, and must be submitted no later than 5:00 p.m. (EST), March 26, 2008.  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 his/her claim to scientific innovativeness and creativity. When possible, give specific examples that illustrate these qualities. Address the likelihood that the applicant will conduct groundbreaking research in HIV/AIDS and drug abuse the proposed research area.

Letters may be submitted from February 26, 2008 to 5:00 p.m. (EST) March 26, 2008 at (https://commons.era.nih.gov/commons/)

The following information is required and must be entered on the letter submission page at the time of submission:

Referee Information:

Note:  The letter submission page can be accessed without signing into the Commons, and referees do not have to be registered in the Commons.  Referees must provide the applicant’s Commons User Name and the other information detailed in this section.

Applicant Information (to be provided to referees by applicants):

Confirmation Number (Required only when resubmitting a letter for the current FOA)

Email 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 when resubmitting letters.  Please print the confirmation email for your records.

Send questions to avant-garde@nida.nih.gov

PHS398 Research Plan Component Sections:

Not applicable.

Appendix Materials:

Appendices are not allowed and will not be accepted. Applications that contain attachments other than those specified may be rejected during the agency validation process.

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

Not applicable.

Section V. Application Review Information


1. Criteria 

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

2. Review and Selection Process

Applications will be evaluated based on the likelihood that the applicant will pursue a highly innovative, cutting edge approach to a problem of relevance to biomedical or behavioral drug abuse HIV/AIDS research, the absence of alternative funding to pursue this direction; and compelling justification for the advantage of evaluation by the Avant-Garde process rather than by the standard peer review process. In particular, reviewers will evaluate:

The following will also be considered in making funding decisions:

Availability of funds

Relevance to program priorities

Applications that are complete and responsive to the FOA will be evaluated by a multidisciplinary group of outside experts using the review criteria stated above. All candidates will be provided with individual scores for each evaluation criterion as well as an overall score.  Those candidates who are identified as the most outstanding will be invited for interviews by a distinguished panel of outside experts. The National Advisory Council on Drug Abuse will conduct the final level of review. The Director, NIDA, will make the final selection of awardees based on the evaluations by the outside experts, the recommendations of the Council, and programmatic considerations. Final selections will be publicly announced, and awards will be made, by the end of September 2008.

2.A. Additional Review Criteria

NOTE: For this FOA only, information regarding protection of human subjects, inclusion of women, minorities and children in research, animal care and use, biohazard protection, and sharing of model organisms should not be submitted with this application. The required information will be requested just-in-time if an award is being considered.

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R).   

Inclusion of Women, Minorities and Children in Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research will be assessed. Plans for the recruitment and retention of subjects will also be evaluated. See the “Human Subjects Sections” of the PHS398 Research Plan component of the SF424 (R&R)

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the adequacy of the plans for their care and use will be assessed. See the “Other Research Plan Sections” of the PHS398 Research Plan component of the SF424 (R&R). 

2.B. Additional Review Considerations

For this FOA, no specific budget information is to be submitted either with the application or just-in-time.

2.C. Sharing Research Data

Not Applicable.

2.D. Sharing Research Resources

Not Applicable.

3. Anticipated Announcement and Award Dates

Finalists selected for interviews and those applicants not selected for interviews will be notified in a timely fashion.   Awardees will be notified in August, 2008, and awards will begin September 20, 2008.

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 NoA and will be provided to the PD/PI and the appropriate institutional official at the time of award:

2a.    When issuing statements, press releases, and other documents describing projects or programs funded with Avant-Garde funds, please use the following   acknowledgement: "This work was funded by the National Institute on Drug Abuse Avant-Garde Award Program for HIV/AIDS Research. Information on the program, is at http://drugabuse.gov/avgp.html.

2b.    As indicated in the FOA, awardees are expected to commit the major portion (at least 51%) of their research effort to activities supported by the award.

3. Reporting

Although there are no stipulations on the research agenda, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.  Awardees will also be required to submit progress reports at the end of each grant period and Final Invention Statements and Financial Status Reports at the end of the award.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

1. Scientific/Research Contact(s):

Jacques Normand, Ph.D.
Director, AIDS Research Program
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd
Rm 5274  MSC 9581
Bethesda, MD 20892
Telephone: 301-443-1470
FAX: 301-594-5610
Email: jnormand@nida.nih.gov

2. Peer Review Contact:

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:

Pam Fleming
Chief, Grants Management Branch
National Institute on Drug Abuse/NIH/DHSS
6001 Executive Blvd., MSC 9541
Rockville, MD  20892-9541
Telephone:  301-443-6710
Fax:  301-594-6849
Email: pfleming@nida.nih.gov

Section VIII. Other Information


Required Federal Citations

Use of Animals in Research:
Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.

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

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (Phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (“NIH Policy for Data and Safety Monitoring,” NIH Guide for Grants and Contracts, http://grants.nih.gov/grants/guide/notice-files/not98-084.html).

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

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see http://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement. Beginning October 1, 2004, all investigators submitting an NIH application or contract proposal are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research” (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the SF424 (R&R) application; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Inclusion of Children as Participants in Clinical Research:
The NIH maintains a policy that children (i.e., individuals under the age of 21) must be included in all clinical research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them.

All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/funding/children/children.htm).

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

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

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov/) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov// and view the Policy or other Resources and Tools, including the Authors' Manual.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the HHS Office for Civil Rights (OCR).

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

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) 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 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov/.


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NIH Funding Opportunities and Notices


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