NOT-NS-10-018: Notice of Availability of Administrative Supplements to Prepare Projects for the Blueprint Neurotherapeutics Network

Notice of Availability of Administrative Supplements to Prepare Projects for the Blueprint Neurotherapeutics Network

Notice Number: NOT-NS-10-018

Key Dates
Release Date: May 14, 2010
Receipt Date: June 18, 2010
Earliest Anticipated Start Date: August 2, 2010

Issued by
National Institute of Neurological Disorders and Stroke (NINDS), (http://www.ninds.nih.gov)
National Institute on Deafness and Other Communication Disorders (NIDCD), (http://www.nidcd.nih.gov)

Purpose

The NINDS and NIDCD have established an administrative supplement program to enable NINDS and NIDCD grantees to prepare projects for entry into the Blueprint Neurotherapeutics Network (http://neuroscienceblueprint.nih.gov/bpdrugs/index.htm). The NINDS plans to award up to 10 administrative supplements for this purpose in Fiscal Year 2010, and the NIDCD plans to award up to 5. Each administrative supplement award will be capped at $50,000 in direct costs.

Background

The NIH Blueprint for Neuroscience Research (http://neuroscienceblueprint.nih.gov/)
has released a Request for Applications to solicit projects for the Blueprint Neurotherapeutics Network (RFA-NS-11-002 https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-11-002.html) and expects to release a second RFA for the same purpose in April 2011. The goal of the Blueprint Neurotherapeutics Network is to develop new small molecule drugs that will transform the treatment of nervous system diseases or conditions. Successful applicants to the network will receive 1) funding to support biological testing of compounds during development and 2) access to technical, infrastructure, and advisory resources. The network will support the stages of drug development beginning with medicinal chemistry and ending with phase I clinical testing. To be competitive for the network, investigators should have:

At least one small molecule compound with strong evidence of biological activity relevant to the intended indication as a starting point for medicinal chemistry optimization.
A robust, moderate throughput assay of biological activity suitable for testing compounds generated in an iterative medicinal chemistry effort. This assay should be capable of providing robust dose-response data on 20-40 compounds in a 1-2 week cycle.
Secondary bioassays and models sufficient to evaluate the potential of a drug candidate for the intended indication.

This administrative supplement program is intended to help NINDS grantees meet the above entry criteria for the Blueprint Neurotherapeutics Network. APPLICATIONS FOR ENTRY INTO THE BLUEPRINT NEUROTHERAPEUTICS NETWORK ARE NOT BEING ACCEPTED AT THIS TIME.

Eligibility

This administrative supplement program is targeted at NINDS and NIDCD grantees who are interested in participating in the Blueprint Neurotherapeutics Network but who may not yet have sufficient data to prepare a competitive application for entry into the network. Administrative supplements may be used for any of the following activities:

Development or optimization of primary or secondary biological assays suitable for testing compounds generated in an iterative medicinal chemistry effort
Prioritization of chemical scaffolds being considered as starting points for medicinal chemistry
Preliminary assessment of structure-activity relationships (SAR)
Validation studies for hits identified through high-throughput screening
PK/toxicology studies to identify liabilities to address through medicinal chemistry

Other activities that may help prepare a project for the Blueprint Neurotherapeutics Network should be discussed with the relevant program contact below, prior to submitting a supplement application. NINDS and NIDCD grantees that plan to submit an application in response to the April 2010 Blueprint Neurotherapeutics Network RFA-NS-11-002 (https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-11-002.html) are eligible to apply for administrative supplements. Receipt of an administrative supplement will not affect peer review of an application submitted under RFA-NS-11-002. NINDS and NIDCD grantees that receive a supplement and are accepted into the network in 2010 must still use the supplement funds as originally intended; this will enable the project to make the best use of network resources.

Principal Investigators with Research Project (R01), Javits Award (R37), Exploratory/Developmental (R21), phase II SBIR (R44), Phase II STTR (R42), Program Project (P01), Specialized Center (P50 or U54), and Cooperative Agreement (U01) grants funded by NINDS or NIDCD are eligible to apply for administrative supplements.

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.

IMPORTANT: The research proposed by the NIH grantee in the supplement application must be within the original scope of the NIH-supported grant project. The funding mechanism being used to support this program, administrative supplements, can be used to cover cost increases that are associated with achieving certain new research objectives as long as they are within the original scope of the project. Any cost increases need to result from making modifications to the project in order to take advantage of opportunities that would increase the value of the project consistent with its originally approved objectives and purposes.

Submitting an Administrative Supplement Request

To be considered for an administrative supplement, please submit a request in writing to the NINDS contacts listed in How to Apply, 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. Applicants may submit only one supplement request per grant.

Requests under this notice should use the PHS 398 forms (rev. 11/2007; available at https://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-NS-10-018), 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 (NOT-NS-10-018, “Notice of Availability of Administrative Supplements to Prepare Projects for the Blueprint Neurotherapeutics Network) 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) A 1-page introduction.

b) 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. Describe the relationship of the supplement request to the parent grant. Provide a brief description of the drug development project that would be submitted to the Network, including the disease of interest, the intended molecular or cellular target, the compound(s) proposed for development, and assays and disease models to be used. Describe the current status of the drug development project and how the supplement will enable it to meet the entry criteria for the Network. This section should include a description of the supplement's specific aims, including research design and methods and data analysis. This section should also indicate how any additional drug development expertise required for the supplement studies (e.g., expertise in assay optimization or SAR analysis) will be obtained.

c) Budget for the supplement with a justification that details the items requested, including Facilities and Administrative costs. See Budget and Funding Information below.

d) Biographical Sketch for all new key personnel (those who are additions on the supplemental project) MS Word PDF

e) 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).

f) PHS 398 Checklist Form MS Word PDF

Selection Factors

Administrative supplement requests will be reviewed administratively by a committee of NIH 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 of the supplemental study
The potential of the proposed work to result in a project suitable for entry into the Blueprint Neurotherapeutics Network.

Budget and Funding Information

For FY 2010, $750,000 will be available for administrative supplements to existing NINDS research projects, and $375,000 will be available for NIDCD projects. Applicants may request up to $50,000 in direct costs. Supplements may be requested for one year and may extend no longer than the parent grant. Applicants must submit a budget using the same budget format as was used for the parent award. Any no-cost extension must be in place before submission of the revision application. Supplement funds may be used for reagents and/or for personnel costs, including the costs of hiring drug development consultants. No requests for equipment will be considered.

How to Apply

This is a one-time announcement. Applications must be received on or before June 18, 2010. Do not send applications to the NIH Center for Scientific Review. Applicants should submit an electronic copy as an e-mail attachment in PDF format to rebecca.farkas@nih.gov and one original, hard copy of the request packet (with original signatures of the authorized business official) to the following address :

Tijuanna E. Decoster, MPA
National Institute of Neurological Disorders and Stroke
National Institutes of Health
6001 Executive Boulevard, Room 3258
Bethesda, MD 20892-9525
EXPRESS/COURIER: Rockville, MD 20852

Inquiries

Inquiries and discussion of plans for responding to this Notice are strongly encouraged.

NINDS Program Contact:
Rebecca Farkas, Ph.D.
National Institute of Neurological Disorders and Stroke
National Institutes of Health
6001 Executive Boulevard, Room 2229
Bethesda, MD 20892-9525
EXPRESS/COURIER: Rockville, MD 20852
(301) 496-1779
Email: rebecca.farkas@nih.gov

NIDCD Program Contact:
Nancy L. Freeman, Ph.D.
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
National Institutes of Health
6120 Executive Boulevard, Room 400C
Bethesda, MD 20892
(301) 402-3458
freemann@mail.nih.gov

NINDS Grants Management Contact:
Tijuanna E. Decoster, MPA
National Institute of Neurological Disorders and Stroke
National Institutes of Health
6001 Executive Boulevard, Room 3258
Bethesda, MD 20892-9525
EXPRESS/COURIER: Rockville, MD 20852
(301) 496-9231
decostert@mail.nih.gov

NIDCD Grants Management Contact:
Christopher Myers
Division of Extramural Activities
National Institute on Deafness and Other Communication Disorders
National Institutes of Health
6120 Executive Boulevard, EPS 400B
Bethesda, MD 20892
(301) 435-0713
myersc@nidcd.nih.gov

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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