Loren Data's SAM Daily™

FBO DAILY ISSUE OF JULY 25, 2008 FBO #2433
SOLICITATION NOTICE

B -- Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS) Initiative, Phase I

Notice Date

7/23/2008
 

Notice Type

Presolicitation
 

NAICS

541690 — Other Scientific and Technical Consulting Services
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

FDA-SOL-08-SAFEKIDSInitiativePhaseI
 

Archive Date

9/19/2008
 

Point of Contact

Ron Loube,, Phone: (301) 827-7031, Terry Frederick,, Phone: (301) 827-7043
 

E-Mail Address

Ronald.Loube@fda.hhs.gov, Terry.Frederick@fda.hhs.gov
 

Small Business Set-Aside

N/A
 

Description

The FDA intends to issue an RFP to provide non-clinical and clinical studies to assess the effects of anesthetics and sedatives on the developing human brain, including long-term studies in neonates and young children, as well as overarching coordination and program management activities, in furtherance of the Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS) Initiative. FDA’s mission is to protect the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public health by fostering innovations that make medical products more safe, effective, and affordable. As part of its goal of fostering innovation, FDA seeks to identify and address those scientific and technical obstacles to the optimum development of safe and therapeutically important medical products. A key aspect of the Agency’s mission is to identify, and help address, potential safety concerns associated with all products under its jurisdiction and this includes the use of anesthetics and sedatives in pediatric patients. Non-clinical studies in juvenile animal models have shown that exposure to some anesthetics and sedatives is associated with neurodegenerative changes in the central nervous system, as well as memory and learning deficits. Anesthetic agents that have been specifically implicated are NMDA receptor antagonists, such as ketamine, and GABA agonists, such as sevoflurane. The anesthesia community and the FDA acknowledge that there are insufficient human data to either support or refute the clinical relevance of these findings for pediatric patients. Therefore, additional non-clinical and clinical studies will be needed to assess the effect of anesthetics and sedatives on the developing human brain, including long-term studies in neonates and young children. The SAFEKIDS Initiative is a new requirement and will be a multi-phased, multi-year effort; however, the subject synopsis is expected to encompass only the initial phase of the overall initiative. FDA anticipates soliciting proposals from entities capable of completing one or more of the following tasks/studies: (1) Assessment of long-term neurodevelopmental outcomes in pediatric patients administered regional or general anesthesia as neonates or infants; (2) Assessment of the pharmacokinetics, pharmacodynamics, and short- and long-term neurotoxic effects of an anesthetic in infants undergoing various surgical procedures; (3) Assessment of the effects of anesthetic exposure on neurocognitive, emotional and behavioral outcomes; (4) Assessment of long-term cognitive development following general anesthesia as an infant; (5) Evaluation of mechanisms of and potential prevention of neurotoxicity after administration of an inhalation anesthetic in an animal model; and (6) Development of an administrative and scientific infrastructure to support the creation and execution of a series of projects under the SAFEKIDS Initiative The period of performance for each individual task order listed above is expected to be approximately 26 months from date of award. Planning and performing studies to address the aforementioned issues will involve enormous challenges in terms of design, assurance of validity and reliability of the outcome measures, and ethical considerations. Because it is unlikely that any one entity will possess all of the necessary expertise and resources to accomplish all work required under this requirement in a timely and efficient manner, it is expected that the services will be provided under an Indefinite Delivery / Indefinite Quantity (IDIQ) Multiple Award Contract with Firm-Fixed-Price (FFP) Task Orders. There is no predetermined number of awardees: More than one individual task order may be awarded to a single deserving entity. FDA anticipates (1) soliciting the services as a “Full and Open” competitive requirement: Not as a set-aside for any specific class of business concern and (2) utilizing the procurement methods proscribed in FAR Part 15 – Contracting by Negotiation. The primary location of performance is anticipated to be at the contractor’s preferred location; however, the contractor will be required to travel to the Washington, DC/Maryland geographical area. The designated North American Industry Classification System (NAICS) code is anticipated to be: 541690 – Other Scientific and Technical Consulting Services. This industry comprises establishments primarily engaged in providing advice and assistance to businesses and other organizations on scientific and technical issues (except environmental). This announcement is not a request for proposal (RFP). FDA anticipates release of the RFP on or around August 7, 2008. It will be available on the Federal Business Opportunities Web Site Home Page: http://fedbizopps.gov. The anticipated proposal due date and award date for this effort is expected to be on or around September 6, 2008, and September 19, 2008, respectively.
 

Web Link

FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=4b49e4b6eb878a7fb767f55e0212c1ed&tab=core&_cview=1)
 

Place of Performance

Address: Contractor’s preferred location..., Travel required to Washington, DC/Maryland, Rockville, Maryland, 20857, United States

Zip Code: 20857
 

Record

SN01621287-W 20080725/080723223613-4b49e4b6eb878a7fb767f55e0212c1ed (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 |