and Human Services (HHS)
EXPIRED
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:
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
301-710-0267, Email: [email protected].
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 |
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 [email protected]
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.
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: [email protected]
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: [email protected]
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: [email protected]
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/.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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