SOLICITATION NOTICE
A -- NINDS Epilepsy Therapy Screening Program
- Notice Date
- 3/9/2016
- Notice Type
- Presolicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Neurological Disorders and Stroke, 6001 Executive Boulevard, Neuroscience Center, Suite 3287, MSC 9531, Bethesda, Maryland, 20892-9531
- ZIP Code
- 20892-9531
- Solicitation Number
- RFP-NIH-NINDS-16-02
- Archive Date
- 3/31/2016
- Point of Contact
- Jason S Williams, Phone: (301) 496-5985, Kirkland L. Davis, Phone: (301) 496-1813
- E-Mail Address
-
willjas@mail.nih.gov, kd17c@nih.gov
(willjas@mail.nih.gov, kd17c@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- THIS IS NOT A REQUEST FOR PROPOSALS (RFP). THIS IS A PRE-SOLICITATION ANNOUNCEMENT ONLY. A REQUEST FOR PROPOSALS WILL BE ISSUED VIA FEDBIZOPPS ON OR ABOUT 15 DAYS FROM THE DATE OF THIS ANNOUNCMENT (ON OR ABOUT MARCH 24, 2016). FULL TITLE: "Screening of Investigational Compounds to Treat, Modify or Prevent Epilepsy for the NINDS Epilepsy Therapy Screening Program (ETSP)" The NINDS Epilepsy Therapy Screening Program (ETSP), until recently known as the Anticonvulsant Screening Program (ASP), was established in 1975 to address a critical need for new anti-seizure medications and to promote industry interest in their development. Since its inception, the program has been supported through a contract to the University of Utah, which NINDS initially awarded after open competitions in 1974, 1980, and 1984, and renewed thereafter on a sole-source basis. The screening process involves researchers from academia and industry in the U.S. and abroad ("ETSP participants") submitting compounds to the ETSP for investigation in a series of animal (rodent) acute and chronic seizure models. These tests are performed blinded by the contract laboratory and on a confidential basis through a written agreement between the NINDS and the ETSP participant at no cost to the ETSP participant. The NINDS ETSP program office reports test results to participants and provides advice on future steps for promising compounds, while protecting confidentiality and intellectual property. Approximately, 32,000 compounds have been screened to date, and the ETSP has contributed to bringing 10 anti-seizure drugs to market since 1990, with a major role in some and a minor role in others. The ETSP was recently reviewed by Working Groups commissioned by the National Advisory Neurological Disorders and Stroke (NANDS) Council in 2011 and 2014. The Working Groups' recommendations were consistent in both reviews in favor of prioritizing the identification of treatments for drug refractory epilepsy, epileptogenesis, and disease modification over the identification of additional undifferentiated anti-seizure drugs. The new name of the program emphasizes that a major focus is going beyond the symptomatic treatment of seizures to identifying agents that have the potential to prevent their development or disease progression. The envisioned contract award is a re-competition/follow-on requirement to the current National Institute of Neurological Disorders and Stroke (NINDS) Anticonvulsant Screening Program (ASP) requirement (now re-named "Epilepsy Therapy Screening Program ETSP") currently being performed under NINDS contract HHSN271201100029C at the University of Utah, where the requirement has been performed since the inception of this program in 1975. The Contractor during the performance period of the contract shall perform annually various preclinical pharmacological evaluations of potential therapeutic agents for the treatment of epilepsy and related disorders. On an "as needed" basis, Contractor shall also adapt, develop, validate and implement new models to support the ETSP mission and conduct supporting pharmacokinetic studies using normal or epileptic animals. The envisioned contract will support the conduct of preclinical pharmacological evaluations of potential therapeutic agents (typically small molecules but will also include some biologics) and referred to as ETSP investigational compounds for the treatment of epilepsy and related disorders. This contract shall require the Contractor to conduct studies including, but not limited to, the following performance areas: 1) pharmacoresistant epilepsy, 2) models of special epilepsy populations and genetic models and 3) disease modification and anti-epileptogenesis. Initial in vivo testing will routinely utilize male mice and/or rats but female animals will also be required on specified investigational compounds. It is anticipated that one award will be made for a base period of one year with four successive 12-month Term Options for a total potential performance period of 5 years. Subject solicitation will be issued on the basis of full and open competition whereby all responsible sources may submit a proposal which shall be considered by the agency. The RFP will be made available electronically, on or about 15 days from the date of this announcement (on or about March 24, 2016) via the FedBizOpps website (http://www.fbo.gov). Offerors are responsible for routinely checking the FedBizOpps website for any possible solicitation amendments that may be issued.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NINDS/RFP-NIH-NINDS-16-02/listing.html)
- Place of Performance
- Address: Contractor's facility, United States
- Record
- SN04045710-W 20160311/160310000732-907dd325e790f53b360e61ca349c8264 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |