Notice of Availability of Administrative Supplements for Drug Abuse Research on GALT and HIV/SIV Pathogenesis
Notice Number: NOT-DA-08-036
Update: The following update relating to this announcement has been issued:
- October 3, 2008 - See Notice (NOT-DA-08-041) Clarification of Budget Limits.
Key Dates
Release Date: August 15, 2008
Receipt Date: November 21, 2008
Earliest Anticipated Start Date: February 1, 2009
Issued by
National Institute on Drug Abuse (NIDA), (http://www.nida.nih.gov)
Purpose
The National Institute on Drug Abuse announces an administrative supplement program of $2,500,000 in Fiscal Year 2009 to provide funds to NIDA-supported research projects for drug abuse research on gut-associated lymphoid tissue (GALT) and HIV/SIV Pathogenesis. The purpose of this program is to stimulate collaborative, multidisciplinary basic and clinical research to investigate whether chronic exposure to drugs of abuse or being a drug user/abuser affects: 1) SIV/HIV replication in gut-associated lymphoid tissue, 2) depletion of CD4+ cells in GALT, 3) the development of enteropathy and translocation of microbial products, 4) sustained immune activation and pathogenic sequelae. Research is also needed on whether substance abuse influences restoration of CD4+ cells in GALT and gut mucosal repair and restoration following anti-retroviral therapy. In addition, studies of substance abuse influences on the persistence of viral replication in gut CD4+ cells and other viral reservoirs are needed. Proposed supplements should take advantage of ongoing studies using the SIV model, other relevant model systems (e.g., ex vivo or in vitro studies using HIV or SIV), and cohorts of HIV infected patients or substance abusers at high risk for acquiring HIV.
Background
Recent studies have highlighted the importance of early events in HIV/SIV infection on subsequent pathogenesis. Mucosal tissues, particularly gut-associated lymphoid tissue (GALT), harbor the majority of memory T cells and a large proportion of the total T cell population in the body. During acute HIV/SIV infection GALT shows high levels of viral replication followed by severe CD4 T-cell depletion. Persistent viral infection in GALT leads to enteropathy and microbial translocation, which in turn leads to systemic immune activation. The loss of T effector-memory cells and the degree of their restoration in GALT as well as the magnitude of innate and adaptive immune responses appear to be critical determinants of AIDS progression. Whether exposure to drugs of abuse affects the depletion of GALT CD4+ cells or the development of enteropathy associated with HIV-1 infection is unknown. NIDA-funded research has demonstrated effects of drugs of abuse on both T cell function and permeability of the gut, yet the link between substance abuse and GALT immune responses has been largely unexplored. Furthermore, although the effects of HAART therapy on viral suppression and CD4 T-cell restoration in peripheral blood have been extensively investigated, there are limited data on how HAART impacts the restoration of the gastrointestinal mucosal immune system and how substance abuse affects this process.
Eligibility
The current announcement is for supplements to NIDA-supported R01, R37, P01, P30, P50, P60, U01, and U10 research projects. To be eligible, the parent grant must be active, and the research proposed in the supplement must be accomplished within the competitive segment. The proposed supplement MUST be within the general scope of the peer-reviewed activities and aims approved within the parent grant.
Submitting an Administrative Supplement Request
To be considered for an administrative supplement, submit a request in writing to the Institute/Center, not to the Division of Receipt and Referral, Center for Scientific Review. The request must be signed by the authorized Business Official and describe the need for additional funding and the categorical costs.
Requests under this notice should use the PHS 398 forms (rev. 11/2007; available at http://grants.nih.gov/grants/funding/phs398/phs398.html) and include the following elements in the request packet. Font size restrictions apply as designated within the PHS398 (rev. 4/2006) instructions.)
1) Cover Letter - Citing this Notice (NOT-DA-08-036), a request for an Administrative Supplement, and the following information:
- Project Director/Principal Investigator (PD/PI) name
- Parent grant number and title
- Amount of the requested supplement
- Name and title of the institutional official, and
- Phone, email, and address information for both the PD/PI and institutional official.
The cover letter must be signed by the authorized organizational representative/institutional official.
2) PHS 398 Form Page 1 (Face page) MS Word PDF
- The title of the project (Box 1) should be the title of the parent award.
- This Notice (number and title, Notice of Availability of Administrative Supplements for Drug Abuse Research on GALT and HIV/SIV Pathogenesis) should be cited in Box 2, and the yes box should be checked.
- The Principal Investigator (PI) must be the same as the PI on the parent award. For Multiple PI parent awards, the Contact PI must be the PI listed on the supplement request, and the supplement cannot change the Multiple PI team.
- The remaining items on the face page should be filled out in accordance with the PHS 398 application instructions.
3) PHS 398 Form page 2 MS Word PDF
Note: The project summary is that of the administrative supplement, not the parent grant.
4) A brief proposal describing the project, including:
a) Scope of the overall project and the anticipated contribution of the requested supplement (not to exceed five pages). Provide a brief description of the scope of the overall project on which the supplemental request is based.
This section should include a description of the supplement's specific aims, including research design and methods and data analysis. Describe the relationship of the supplement request to the parent grant.
b) Budget for the supplement with a justification that details the items requested, including Facilities and Administrative costs. See Budget and Funding Information below.
c) Biographical Sketch for all new key personnel (those who are additions on the supplemental project) MS Word PDF
d) Human Subjects/ Vertebrate Animal documentation (if applicable). Include a current Human Subjects/IRB or Vertebrate Animals/IACUC approval letter, if available. Otherwise, this will be required at the time of funding. All appropriate IRB and IACUC approvals must be in place prior to a supplement award being made.
Any differences in the involvement or use of human subjects or specimens, or use of vertebrate animals, between the administrative supplement activity and the parent grant should be noted. When appropriate, details should be provided on the protection of human subjects and inclusion of women, children, and minorities. Additional guidance on Human Subjects Research and Vertebrate Animals is provided under Part II of the PHS 398 instructions (http://grants1.nih.gov/grants/funding/phs398/phs398.html).
e) PHS 398 Checklist Form MS Word PDF
Selection Factors
Administrative supplement requests will be reviewed administratively by NIDA Program and Grants management Staff. Selection factors will include the following:
- Relevance of the proposed activities to the parent grant
- Adequate progress of the parent grant appropriate to the current stage of the project
- Appropriate and well-described plan to accomplish the goals within the timeframe proposed
- Expertise of the research team proposed to conduct and achieve the goals the supplemental study.
Budget and Funding Information
For FY 2009, $2,500,000 will be available for administrative supplements to existing research projects. Administrative supplements are generally limited to less than 25 percent of the Council-approved direct costs for the current budget year of the project or under $100,000, whichever is less, but given the expense involved in SIV and clinical studies and the possible need to add collaborators, administrative supplements above these limits will be considered. Supplements may be requested for up to two years but may extend no longer than the parent grant. It is anticipated that supplemental funding will begin in early calendar 2009.
How to Apply
This is a one-time announcement. Applications must be received on or before November 21, 2008. Do not send applications to the NIH Center for Scientific Review.
Submit one original, hard copy of the request packet (with original signatures of the authorized business official) to the NIDA address listed below:
Carol Alderson
Grants Management Branch
National Institute on Drug Abuse
6101 Executive Boulevard, Room 270
Rockville MD 20852 (for Express/Courier Delivery)
(For regular U.S. Mail: 6101 Executive Boulevard, MSC 8403, Bethesda MD 20892-8403)
In addition, applicants are encouraged to send an electronic copy of the submitted supplement request as an e-mail attachment in PDF format to the program and grants management contacts listed below under Inquiries.
Inquiries
Inquiries and discussion of plans for responding to this Notice are strongly encouraged.
Program Contact:
Diane M. Lawrence, Ph.D.
AIDS Research Program
National Institute on Drug Abuse
National Institutes of Health
6001 Executive Blvd
Rm 5274, MSC 9581
Bethesda, MD 20892-9555
EXPRESS/COURIER: Rockville, MD 20852
Phone: (301) 594-3225; Fax: (301) 594-5610
Email: [email protected]
Grants Management Contact :
Carol Alderson
National Institute on Drug Abuse
National Institutes of Health
6101 Executive Blvd
Suite 270, MSC 8403
Bethesda, MD 20892-8403
EXPRESS/COURIER: Rockville, MD 20852
Phone: (301) 594-5614; Fax: (301) 594-6849
Email: [email protected]
and Human Services (HHS)
