Administrative Supplements for Translational Aging Research leading to New Interventions, Health Practices and Policies

Notice Number: NOT-AG-07-006

Key Dates
Release Date: May 4, 2007
Application Receipt Date: July 16, 2007
Earliest Anticipated Start Date: December 1, 2007

Issued by
National Institute on Aging (NIA), (http://www.nia.nih.gov/)

Purpose

The National Institute on Aging supports research in a variety of scientific disciplines. However, a paramount ultimate goal of the NIH is the application of the knowledge acquired to extend healthy life and reduce the burdens of illness and disability. In an effort to facilitate more rapid movement of NIA-supported research towards that goal, the NIA is requesting applications for administrative supplements for NIA-funded R01, P01, MERIT (R37), Cooperative Agreement (U01) grants to domestic institutions interested in pursuing translational research directly relevant to their currently funded grants. Requests for supplemental funding should demonstrate that the proposed translational research exploits a promising research opportunity or takes advantage of new technology that fits within the scope of the parent grant and that timely progress towards translation is best supported by an administrative supplement. Depending on the merit of the requests received and the availability of funds, the NIA may award up to $2 million per year in supplemental funding in connection with this funding opportunity announcement in FY08. The administrative supplements may be awarded for up to two years with the second year of support dependent on demonstrated progress on milestones established by the PI and approved by program staff. At the end of the supplemental period of either one or two years, the research supported should demonstrate whether additional testing of the proposed intervention is warranted. Thus, the supplement is intended to encourage extension of the course of research from the original research findings to a point where further support of an independent translational or clinical grant proposal can be generated for funding under mechanisms such as the R01 or P01. Potential applicants are strongly encouraged to contact their Program Official as identified on the Award notice, to determine eligibility of their proposed projects for this funding opportunity.

Research Objectives

The primary objective of this announcement for administrative supplements is to facilitate the broad range of studies needed for the translation of both basic aging research into new interventions targeting aging conditions (“T1” translational research) and for implementation of health practices and policies affecting the elderly (“T2”). Requests for supplemental funding for “T1” research may involve studies leading to the development of new drugs, therapeutic biological products, as well as to the development of non-pharmacological interventions (e.g. exercise) and devices targeted at preventing or improving aging related conditions or pathologies. Investigators with NIA-funded basic research parent projects must demonstrate within the request that the course of research extends the results from their parent grant using appropriate models and techniques for eventual clinical development. The application must propose a course of investigation that clearly progresses toward clinical testing of the proposed treatment, with milestones to be achieved for each year of supplemental funding.

Translational research projects proposed in humans must provide evidence of approval for inclusion of human subjects and necessary assurances for human subjects as part of their parent NIA-supported study. If human testing is proposed, the applicant may also be required to have an existing Investigational New Drug (IND) application with the Food and Drug Administration (FDA) and have completed the preclinical studies to support the proposed human testing, per FDA guidance.

“T1” translational studies appropriate for this NIA supplemental funding opportunity include various types of studies needed to better define therapeutic targets and/or to test efficacy of proposed new interventions. Exploratory studies in both animals and in humans may be proposed. The type of translational studies to be supported under this funding opportunity will depend on the stage of development of the scientific field. Because this funding opportunity is for supplements to existing grants, the goals of each of the four programs within NIA are slightly different, and they are stated below. Applicants are encouraged to contact the Program Official associated with their active grant to establish eligibility and other criteria.

Biology of Aging Program (BAP)
Supplements to grants administered by BAP should be directed towards gathering more substantive evidence of the translational potential of therapeutic interventions to retard or reverse age-related conditions such as sarcopenia, osteoporosis, impaired wound healing and/or immunodeficiencies, among others. These administrative supplements may be used to pursue in vivo or vitro studies designed to validate the potential of new targets that have been identified for possible use as therapeutics for various age-related pathologies. Supplements may be used to support a range of studies, including work in model organisms or animal models, to evaluate the translational potential of treatments for aging conditions. Examples of aging-specific potential translational projects of interest to BAP include, but are not limited to:

Neuroscience and Neuropsychology of Aging (NNA) Program
The Neuroscience and Neuropsychology of Aging Program will be providing administrative supplements for R01, R37 and P01 grants, for research aimed at the validation of novel therapeutic targets for age-related cognitive decline, mild cognitive impairment, Alzheimer’s disease and other dementias of aging. Approaches aimed at manipulating the expression and/or function of a molecular target both in vitro and in vivo and demonstrating that these manipulations critically influence molecular, biochemical, electrophysiological, cognitive and other behavioral readouts relevant to the above conditions will be eligible for support. Acceptable manipulations include but are not limited to the generation and use of:

- antisense DNA/RNA oligonucleotides
- gene silencing using interfering RNAs (dsRNA, siRNA)
- transgenic animal models such as conditional knockouts, knockins or gain of function models

The use of various model organisms such as C. Elegans, Drosophila Melanogaster, mice, rats and others, for the purpose of validating a new target is strongly encouraged.

Geriatrics and Clinical Gerontology (GCG) Program
The Geriatrics and Clinical Gerontology Program is interested in the full spectrum of translational research from bench to bedside, as well as the application of findings from clinical research to the development of new healthcare strategies and policies for older adults. Requests for supplemental funding to GCG-supported grants may involve studies leading to the development of new drugs or therapeutic biological products, as well as to the development of non-pharmacological interventions (e.g., exercise) and devices targeted at aging conditions or processes. Topics of interest include, but are not limited to translational studies leading to novel interventions for prevention or treatment of aging conditions, geriatric syndromes, and previously unappreciated pathologic conditions in old age (e.g., vascular stiffening, diastolic dysfunction). Examples of potential types of translational projects include, but not limited to:

Topics of interest to GCG related to translational studies leading to improved health care and polices include but are not limited to those listed below by the Behavioral and Social Research Program.

Behavioral and Social Research (BSR) Program
“T2” studies refer to translation from research results to public policy or private-sector decisions. Requests for supplemental funding for “T2” translational research under this initiative will be specifically designated for behavioral and social science studies (or other studies that would benefit from social, behavioral and economic approaches) with research results relevant for 1) translation into state/federal/international public policy, 2) adoption by agencies or firms (e.g., insurance companies, employers, nursing homes), 3) translation into public health practice, 4) development into new technologies, and 5) development into behavior change/behavior maintenance programs. These supplements must have an aging or lifespan focus. Where appropriate, administrative supplement funds may be requested to collect additional data and to work with relevant organizations urging adoption of new or changed policies or programs. Appropriate topics for these supplements include, but are not limited to the following.

Eligibility

Before submitting an application for supplemental funding, all grantees should communicate with his/her Program Official to discuss the planned application.

All applications requesting these administrative supplements must include information demonstrating that the projects meet the following conditions: (1) the focus of the supplemental research being proposed is directly related to and within the scope of the research being performed under the parent NIA-supported grant; (2) there are no funds in the parent award to specifically pay for the proposed effort; (3) the parent grant is active during the entire funding period of the requested supplement; and (4) the Principal Investigator (PI) for the supplement must be the PI of the parent grant.

This program will support administrative supplements to NIA-supported Research Project (R01), Program Project (P01), MERIT (R37), or Cooperative Agreement (U01) awards to domestic institutions. Awards to foreign institutions are not eligible for supplementation under this program. Applications for these supplements will not be accepted until after a Notice of Grant Award has been issued for the parent grant application. Awards that are in a no-cost extension will not be considered for support under this supplement program. Only one supplement may be requested for any individual award.

How to Apply

This is a one-time announcement. Applications must be received on or before July 16, 2007. Do not send applications to the Center for Scientific Review. Applicants should submit one electronic copy as an e-mail attachment in PDF format and one hard copy (with original signatures of the PI and institutional official) of the application to:

Chhanda Dutta, PhD Chief,
Clinical Gerontology Branch
Geriatrics and Clinical Gerontology Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 3C-307
Bethesda, MD 20892 (ZIP 20814 for Fed Ex)
Telephone: (301) 435-3048
FAX (301) 402-1784
Email: duttac@nia.nih.gov

Content and Form of Application Submission

Applications for an administrative supplement under this program should use the PHS 398 form (rev. 9/2004; available at http://grants.nih.gov/grants/funding/phs398/phs398.html), and must include the following:

1. Cover letter requesting the supplement, identifying this notice, the number and title of the parent grant, and providing full principal investigator (PI) contact information.

2. Face page.

The title of the project (Box 1) should be the title of the parent award.

This Notice (number and title) 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. Subproject PIs on P01 and U01 awards are not eligible to apply for these supplements.

The remaining items on the face page should be filled out according to the PHS 398 application instructions.

3. Form page 2 (Description, Performance Sites, Key Personnel, Other Significant Contributors, and Human Embryonic Stem Cells) from PHS 398. The project description is that of the administrative supplement, not the parent grant.

4. Biosketch(es) for any new key personnel or consultants not named in the parent grant. Letters of commitment from these new participants should be included in section J (Consultants) of the Research Plan.

5. Resources page and Other Support page for any new key personnel not named in the parent grant.

6. Budgets may not exceed $100,000 in direct costs per year. All requests require an itemized budget and must be countersigned by the grantee institution’s business office on the face page. See “Budget Information” section below.

7. A one-page description of the parent award, including a brief update on progress made thus far. List any publications resulting from the parent award (this list will not be counted toward the one-page limit of this section).

8. Research Plan for the supplement, items A-D not to exceed five pages. Font size restrictions apply as designated within the PHS398 (rev. 4/2006) instructions.

The application should contain sufficient detail (similar to a standard research application) to allow assessment of the scientific merit of the proposed research plans and the appropriateness of the request for supplemental funding. This section should include a description of the supplement's specific aims (A), background and significance (B), preliminary studies (C), and research design and methods (D). It must also describe how the specific aims of the parent project will be enhanced by the supplement, and should make a strong scientific case that the proposed supplemental research will make a substantial contribution to the translation of the system under study in the parent grant towards clinical application. If collaborators are not at the same institution, describe how they will work together on the supplement project.

Human subjects research (item E of the Research Plan) : If there is a change, relative to the parent award, in any matter related to human subjects research, the application should include a complete Human Subjects Research section (E) as required in the PHS 398 instructions. This section will not be counted toward the five-page limit of the research plan. We urge all applicants to begin the process of obtaining IRB approval of any changes to the human subject protocols covering the parent award as soon as possible, if the supplementary project requires it. If there is no change, relative to the parent award, in any matter related to human subjects research, this should be stated. If human subjects are involved, requests for supplements under this program must comply with NIH policies for inclusion of women, minorities and children in research involving human subjects.

Items G (Literature Cited), H (Consortium/Contractual Arrangements), I (Resource Sharing) and J (Consultants) should be completed as described in the PHS 398 Instructions.

9. A completed Checklist.

10. Appendices will not be accepted.

Review Criteria

Requests will be evaluated by NIH program staff with expertise relevant to the proposed translational research project. The applicant will be notified by their Program Official regarding the review outcome. Awards will be determined on the basis of scientific merit, program relevance, potential to build a translational research project, and availability of funds.

Budget Information

Applicants may request up to $100,000 in direct costs for each year of the administrative supplements under this program. Facilities and Administrative (F&A) costs will be paid at the full, negotiated rate.

Inquiries

Applicants should provide a budget justification that details the direct cost of all budget items requested. In fiscal year 2008, the NIA plans to commit approximately $2 million per year toward this program, with approximately 13 supplement awards anticipated. Inquiries Applicants are strongly encouraged to discuss their plans for responding to this Notice by phone or e-mail. Scientific inquiries should be directed to the NIA Program Official who oversees the parent grant associated with the administrative supplement request. Additional questions regarding appropriateness of the project for this supplemental award may be addressed to the contacts listed below.

The earliest anticipated award date for this program will be December 1, 2007.

Direct inquiries concerning programmatic and review matters to:

Chhanda Dutta, Ph.D.
Geriatrics and Clinical Gerontology
National Institute on Aging
7201 Wisconsin Avenue, Suite 3C307
Bethesda, MD 20892
Telephone (301) 435-3048
FAX: (301) 402-1784
Email: duttac@nia.nih.gov

Rebecca Fuldner, Ph.D.
Biology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 2C2231
Bethesda, MD 20892
Telephone: (301) 496-6402
FAX (301) 402-0010
Email: Fuldnerr@nia.nih.gov

Suzana Petanceska, PhD
Neuroscience and Neuropsychology of Aging Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 350
Bethesda, MD 20892
Telephone (301) 496-9350
FAX: (301) 496-1494
Email: petanceskas@nia.nih.gov

Georgeanne E. Patmios
Behavioral and Social Research Program
National Institute on Aging
7201 Wisconsin Avenue, Suite 533
Bethesda, MD 20892
Telephone: (301) 496-3138
Fax: (301) 402-0051
Email: PatmiosG@NIA.NIH.GOV

Direct inquires regarding administrative and fiscal matters to:

Linda Whipp Grants Management Officer
Grants and Contracts Management Office
7201 Wisconsin Avenue, Suite 2N212
Bethesda, MD 20892
Telephone: (301) 402-7731
FAX: 301-402-3672
Email: whippl@nia.nih.gov


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NIH Funding Opportunities and Notices


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