MODIFICATION
A -- Study on the use of Ketamine in children for short-term procedures in the Emergency Department
- Notice Date
- 12/9/2009
- Notice Type
- Modification/Amendment
- NAICS
- 541712
— Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, Maryland, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-RFI-11-09
- Archive Date
- 1/30/2010
- Point of Contact
- Lynn L Salo, Phone: 301-435-6962, Elizabeth D Osinski, Phone: 301-435-6947
- E-Mail Address
-
ls59u@nih.gov, eo43m@nih.gov
(ls59u@nih.gov, eo43m@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Key Dates Release Date: December 9, 2009 Response Date: January 15, 2010 There have been two modifications to this announcment, both trying to correct the response date to January 15, 2010. In addition, the NAICS code was changed to 541712. Issued by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (http://www.nichd.nih.gov) Purpose This is a time-sensitive Request for Information that will be used to assess the need to perform pediatric labeling studies of ketamine for short term procedures performed in the Emergency Department. "This is a Request for Information (RFI). This is NOT a solicitation for proposals, applications, proposal abstracts, or quotations. The purpose of this RFI is to obtain knowledge and information for project planning purposes only." Background The Best Pharmaceuticals for Children Act (BPCA) legislation enacted in 2002 (renewed in 2007), directs the (NIH) in consultation with the Food and Drug Administration (FDA) and experts in pediatric research, to develop and prioritize a list of "off-patent" drugs for which pediatric studies are most urgently needed. Ketamine has become one of the most favored drugs used by emergency physicians for sedation of children in the Emergency Department. Despite its extensive use, ketamine is not labeled in pediatrics by the Food and Drug Administration. Ketamine has been prioritized for study by NICHD under BPCA since February 2004. Recently, concerns have arisen about the safety of ketamine due to the appearance of proapoptopic effects in the developing central nervous system in young experimental animals. Neuro-apoptosis have been demonstrated in rodents and non-human primates at doses several fold higher that those used in children. Additionally, in young experimental animals neuro-apoptotic lesions have been associated with long term behavioral deficits. Information Requested The NIH is especially interested in concrete and relevant suggestions to the following questions in order to determine the scientific and regulatory need to sponsor clinical drug studies on the pediatric use of ketamine for short term procedures in the Emergency Room. Questions 1.Are there sufficient data to assess the neurotoxicity of single exposure to ketamine? To what extent is the dose(s) used in nonclinical studies relevant to the exposure levels used in ER departments to achieve sedation and analgesia for short-term procedures? 2.Are the data on the dosage of ketamine in experimental young animals applicable to children receiving ketamine for short term procedures in the Emergency Department? 3. The vulnerability period for the development of neuroapoptosis lesions after ketamine exposure spans from the third trimester of pregnancy to approximately 3 years of age; however the drug is most commonly used in the ER in children 3 years and older. Could labeling studies be safely be performed in children between 3 and 12 years of age? 4. Are data on the pharmacodynamics of ketamine in experimental animals applicable to human study designs? Conversely, are there issues in experimental studies that need to be considered in the design of pediatric studies? 5. Considering the large inter-individual variability in the metabolism of ketamine, should studies be performed to analyze the effects of polymorphisms (CYP2B6, CYP3A4 and CYP2B6) and ontogeny (CYP2C9) of the ketamine-metabolizing enzymes in pharmacokinetics and adverse events? 6. If a two phased study ( i.e., pharmacokinetics and or pharmacokinetics/pharmacodynamics study followed by an efficacy and safety clinical study) is requested, which pharmacokinetic and pharmacodynamic measurements and efficacy and safety endpoints should be included? 7. Considering that racemic ketamine is used in the United States, should PK studies include measurements of ketamine enatiometers? 8. How should the study population of children receiving ketamine for short term procedures in the ER be defined? How to Submit a Response Please provide your response to this Request for Information (RFI) to Lynn Salo at salol@mail.nih.gov no later than January 15, 2010. Responses should be submitted as an e-mail attachment in PDF format. Please limit responses to fifteen (10) pages or less. NICHD will use the information submitted in response to this RFI at its discretion and will not provide comments to any responder's submission. However, responses to the RFI submitted may be reflected in future solicitation(s). NICHD reserves the right to contact any responder that responds to this RFI for the sole purpose of enhancing NICHDs understanding of your RFI submission. The collected information will be analyzed and may appear in reports. "Disclaimer and Important Notes - This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed. Information provided will be used to assess tradeoffs and alternatives available for the potential requirement and may lead to the development of a solicitation. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. Any solicitation resulting from the analysis of information obtained will be announced to the public in Federal Business Opportunities in accordance with the FAR Part 5. However, responses to this notice will not be considered responses to a solicitation. Confidentiality - No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s). Inquiries: Specific scientific questions about this RFI should be provided in writing and directed to the following individual. No questions will be entertained via telephone contact. Lynn Salo Contracting Officer 301-435-6962 salol@mail.nih.gov Contracting Office Address: Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510 Bethesda, Maryland 20892-7510 Secondary Point of Contact: Elizabeth Osinski osinskie@mail.nih.gov Phone: 301-435-6947 Fax: 301-402-3676
- Web Link
-
FBO.gov Permalink
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- Record
- SN02020352-W 20091211/091209235152-0c3b088cb757851ea063a00c7cf6d358 (fbodaily.com)
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