Notice Number: NOT-FD-08-001
Release Date: September 24, 2007
Issued by: Food and Drug Administration/Office of Orphan Products Development and Food and Drug Administration

The Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) is pleased to announce the availability of funds for fiscal year (FY) 2009 and FY 2010 grant awards to support clinical trials on the safety and effectiveness of products for rare diseases and conditions. Contingent on availability of FY 2009 and FY 2010 funds, it is anticipated that $14.2 million will be available for new applications, competing awards, and non competing continuation awards. For FY 2009, the application receipt date is February 6, 2008, and for FY 2010, the application receipt date is February 4, 2009.

These studies are intended to provide acceptable data to the FDA that will substantially contribute to the approval of new products, or new indications for already marketed products. In the FDA OOPD grants program, products for rare diseases and conditions (orphan products) are defined as drugs, biologics, medical devices, and medical foods indicated to treat or diagnose a rare disease or condition with a prevalence of fewer than 200,000 people in the United States.

To read the complete notice, click here.

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Participating Organizations: Food and Drug Administration (FDA)

Components of Participating Organizations: Office of Orphan Products Development (OPD)

Title: Clinical Studies of Safety and Effectiveness of Orphan Products; Research Project Grant (R01)

Request for Application (RFA) Number: RFA-FD-08-001

Opening Date: January 6, 2008 (Earliest date an application may be submitted to Grants.gov)

Application Submission/Receipt Date(s): February 6, 2008; February 4, 2009

Expiration Date: February 5, 2009

For more information, click here. For additional funding opportunities from the National Institutes of Health, click here.

From the SMA Project:

Dear Colleague,

We have now posted the Supporting Documentation (including the Subcontract Agreement) for the SMA Project (http://www.smaproject.org) Request for Proposals (RFP) LD-090707. This RFP seeks to identify facilities to conduct preclinical testing of chemical compounds with the ultimate goal of submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). We have also posted an updated version of the RFP (Attachment B in the RFP has been updated).

The RFP and Supporting Documentation can be accessed through the Solicitations page of the SMA Project website at http://www.smaproject.org/solicitations.html. Proposals are due by 3 p.m. Eastern Time on October 5, 2007.

Studies to be conducted under the resulting contract will include preclinical safety, toxicology, pharmacokinetic/dynamic, and biodistribution studies with candidate small molecule compounds that act as therapeutic agents for spinal muscular atrophy (SMA). While a broad range of Good Laboratory Practice (GLP) and non-GLP studies is anticipated, capability to conduct studies according to GLP is required. Science Applications International Corporation (SAIC), on behalf of the Government, shall supply the Offeror with a small amount of each candidate therapeutic compound. For certain compounds provided to the Contractor, SAIC may request a comprehensive Product Development Plan for services to be provided by the Contractor. Facilities will be evaluated on their past experience in preclinical, IND-directed small molecule development, as well as the proposed schedule and cost of studies required.

The National Institute for Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) launched The SMA Project: A Collaborative Program to Accelerate Therapeutics Development for Spinal Muscular Atrophy in September 2003. This program funds milestone-driven research aimed at identifying and rapidly developing a treatment for SMA, a paralyzing neurodegenerative disease of childhood.

From the SMA Project email service (June 8, 2007):

Dear Colleague,

I am pleased to announce the following funding opportunity for researchers in the field of spinal muscular atrophy (SMA):

The SMA Project (http://www.smaproject.org) expects to release a Request for Proposals (RFP) within the next 14 days to identify and fund facilities capable of providing the necessary research and development support for an Investigational New Drug (IND) submission in a format acceptable to the U.S. Food and Drug Administration (FDA).

The intention is to award a subcontract to a facility capable of conducting safety, toxicology, pharmacokinetic/dynamic, and biodistribution studies with candidate small molecule compounds that act as therapeutic agents for SMA. These studies will be done in partial fulfillment of the requirements for submitting an IND application to the FDA. Science Applications International Corporation (SAIC), on behalf of the Government, shall supply the Offeror with a small amount of each candidate therapeutic compound.

The Offeror will be required to prepare and deliver, for each selected therapeutic compound provided by SAIC for testing, a specific Test Implementation Plan including a proposed budget for the specific testing activities. Activities within the facility shall be highly coordinated with efficacy testing activities outside the facility by SAIC. SAIC shall require from the Offeror preclinical development data that are required by the FDA for filing successful IND applications.

Offers will be due approximately 28 days from the release of the RFP. Relevant documents will be available through the Solicitations page of the SMA Project website at http://www.smaproject.org/solicitations.html.

The National Institute for Neurological Disorders and Stroke (NINDS) (http://www.ninds.nih.gov/) launched The SMA Project: A Collaborative Program to Accelerate Therapeutics Development for Spinal Muscular Atrophy in September 2003. This program funds milestone-driven research aimed at identifying and rapidly developing a treatment for SMA, a paralyzing neurodegenerative disease of childhood.