Notice of Availability of Administrative Supplements for Research on Outcome Measures for Pediatric Clinical Trials in support of the Best Pharmaceuticals for Children Act

Notice Number: NOT-RR-09-005

Key Dates
Release Date:  February 19, 2009
Receipt Date: April 30, 2009
Earliest Anticipated Start Date: September 30, 2009

Issued by
National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov)

Purpose

The National Center for Research Resources (NCRR) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) announce an administrative supplement program of up to $5.0 million in Fiscal Year 2009 to provide funds to CTSA Consortium-supported research projects for research on outcome measures in clinical and translational child health in priority areas as determined by the Best Pharmaceuticals for Children Act program administered by NICHD.  The administrative supplements are to support projects of national scope for established CTSA-wide consortia —defined as the CTSA Oversight Committees or Key Function.

This administrative supplement solicitation requests submissions in the priority areas of pediatric cardiology (measures of clinical outcomes for infants/children/adolescents treated for hypertension or hypotension); neonatology (response outcomes); and pediatric neurology (measures of drug or chemical-induced neurotoxicity).

The purpose of this program is to stimulate collaborative, multidisciplinary basic and clinical research to 1) facilitate the development of qualified outcome measures and 2) relate non-clinical to clinical outcome assessments in child health for improving the evaluation of interventions or 3) assess and interpret clinical outcomes.  This solicitation is to support projects in priority areas listed above and as outlined by the BPCA process (Federal Register 71(79):23931 & Federal Register 72(59):14588).   The purpose is to improve the likelihood of success of pediatric clinical trials, especially drug trials, by identifying more reliable predictors and markers of outcomes.  Administrative supplements must propose projects that remain within the scope of the Aims of the parent grant

Background

The importance of research in support of child health was affirmed in the authorizing legislation and explicitly stated in the FOA for the Institutional Clinical and Translational Science Award (http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-09-004.html).  Proposed projects must contribute to national efforts and relate to the mission of CTSA-wide consortia (defined above) and the goals of Title V of the Food and Drug Administration Amendments Act of 2007 (http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf), also known as the Best Pharmaceuticals for Children Act (BPCA).  A variety of different types of projects are likely to be considered responsive to this solicitation; however, projects must be well thought out with achievable and defined timelines and deliverables, specified personnel, and a justified budget.  For example, projects could focus on development of correlations between non-clinical assessments and child health clinical outcomes, harmonization of clinical outcome measures across different age groups, development of predictive biomarkers or age appropriate outcome measures in one of the priority areas.  High priority will be given to highly focused projects that are consistent with the CTSA and BPCA goals and innovative, creative, and transformative even if risky.  It is expected that a project will be developed and carried out by individuals from multiple CTSA institutions; however, a single CTSA UL1 awardee institution will submit the application for funds for the entire project proposed.  Subcontracts are allowed.

Eligibility

The current announcement is for supplements to NCRR -supported UL1 CTSA research projects.

Any currently funded UL1 CTSA grant recipient may apply and the Principal Investigator must be the PI named on the UL1 award.  However, the application must address a CTSA-wide consortium project (defined above) and not a project that has only local benefits.  Funding will be restricted to the proposed project.  There is no limit on the number of applications a CTSA-wide consortium may endorse or single CTSA UL1 awardee institution may submit.

To be eligible, the parent grant must be active, and the research proposed in the supplement must be accomplished within the competitive segment. 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, 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-NCRR-09-005), a request for an Administrative Supplement, and the following information:

The cover letter must be signed by the authorized organizational representative/institutional official.

2) PHS 398 Form Page 1 (Face page) MS Word  PDF

3) PHS 398 Form page 2 MS Word  PDF

Note: The project “summary” is that of the administrative supplement, not the parent grant.  All other information should be provided.

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). Summarize the activities that were included in the parent grant that encompass those proposed in the supplemental request.
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.
In addition, the research project plan should include the following:

b) Budget for the supplement with a justification that details the items requested, including Facilities and Administrative costs and a justification for all personnel and their role in this project.  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 NCRR and NICHD Program and Grants management Staff with expertise relevant to the proposal but who have no conflict of interest with the proposal.  Awards will be determined on the basis of the merit of the proposal and the availability of funds.  Applicants will be notified regarding the review outcome.

Selection factors will include the following:

Budget and Funding Information

Budgets of $50,000 to a maximum of $ 500,000 total costs can be requested for one year (project period) dependent on the justified needs of the project.  Contingent on the receipt of meritorious proposals and availability of funds, a maximum of up to $ 5,000,000 may be provided for this solicitation.  All awards will be made by September 30, 2009. 

Terms of Award
The terms and conditions of the parent award will apply. Costs awarded will be restricted for the purpose(s) of the supplement.

How to Apply

This is a one-time announcement.  Applications must be received on or before 5:00 PM, ET, April 30, 2009.  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 NCRR address listed below:

Mary Purucker MD, PhD
CAPT, U.S. Public Health Service
National Center for Research Resources
National Institutes of Health
6701 Democracy Blvd., MSC 4874
Bethesda, MD 20892-4874 (use 20817 for express shipments)
Phone: 301-435-0741  Fax :  301-480-3661
E-mail: puruckerm@mail.nih.gov

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.

For administrative questions related to this solicitation, contact

Mary Purucker MD, PhD
CAPT, U.S. Public Health Service
National Center for Research Resources
National Institutes of Health
6701 Democracy Blvd., MSC 4874
Bethesda, MD 20892-4874 (use 20817 for express shipments)
Phone: 301-435-0741  Fax : 301-480-3661
E-mail: Puruckerm@mail.nih.gov

For scientific or technical questions relating to the Best Pharmaceuticals for Children Act and research that would be supported by this solicitation, contact

Anne Zajicek MD, Pharm D
Associate Branch Chief
Obstetric and Pediatric Pharmacology Branch
Center for Research for Mothers & Children
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institutes of Health, HHS
Phone: 301-435-6865, Fax: 301-480-2897
Email: zajiceka@mail.nih.gov


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