MODIFICATION
A -- A DOSE ESCALATION STUDY OF SCOPALAMINE ADMINISTERED AS A NASAL GEL
- Notice Date
- 6/15/2005
- Notice Type
- Modification
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- NASA/Lyndon B. Johnson Space Center, Houston Texas, 77058-3696, Mail Code: BH
- ZIP Code
- 00000
- Solicitation Number
- NNJ05111221Q
- Response Due
- 6/20/2005
- Archive Date
- 6/15/2006
- Description
- THIS NOTICE CONSTITUTES AMENDMENT NO. 01 TO THE COMBINED SYNOPSIS/RFQ FOR A DOSE ESCALATION STUDY OF SCOPALAMINE ADMINISTERED AS A NASAL GEL. Companies shall acknowledge all amendment(s) in their quote. This notice serves as the official amendment to subject synopsis/RFQ and a written amendment will not be issued. The purpose of this amendment is to address the following questions and associated answers: Question 1 Would you have a protocol (or detailed protocol synopsis) available that could be sent to us? If not, please confirm the role we would have in developing the study protocol. Answer to Question 1 The protocol is submitted to FDA ? the vendor does not have a role in the development, the synopsis gives details of the protocol. Question 2 It appears that this is a single-day study, but no further information is given relative to the treatment modality, Please confirm our understanding that this is a single-dose study. Answer to Question 2 Yes, single day sample & data collection for each treatment. The Combined Synopsis/RFQ states - this study is a randomized, double blind, placebo-controlled, dose ranging study of IN SCOP at three dose levels compared to placebo. Subject participation must be randomized to receive four treatments in a four-way crossover design with treatment periods separated by a seven-day washout period. Question 3 Would you have an investigator's brochure available? Answer to Question 3 Yes, will be given after the award. Question 4 Would you confirm the regulatory status of this study, specifically, whether an IND is open? Answer to Question 4 Yes, IND is open. Question 5 Is this a first in man study? Answer to Question 5 No. Question 6 Are CRFs available? If so, could you provide a copy? If not, please confirm that we would develop CRFs for this study. Please confirm that electronic CRFs are acceptable. Answer to Question 6 Yes, they are, but require vendor review as part of the contract before implementation, will be given with the protocol after the award. No, electronic CRFs are not acceptable. Question 7 Please confirm that the deliverable is limited to samples and data, and does not include any statistical analysis or report. Answer to Question 7 Deliverables are not limited to samples and data only. Electronic reports on study progress, procedures, and any study specific information details are also required. Any adverse event reports must be submitted immediately following verbal communication within 24 hours. Question 8 Please confirm that study supplies are available and specify conditions of storage. Answer to Question 8 NASA will provide a Personal Data Assistant (PDA) for subject performance data collections. In reference to study supplies, only the drug dosage form with instructions for storage and handling will be provided. The due date for receipt of offers is not extended. Companies shall provide the information stated in the synopsis/RFQ posted on the NASA Acquisition Internet Service (NAIS) on June 13, 2005. Documents related to this procurement are available over the Internet. These documents reside on a World Wide Web (WWW) server which may be accessed using a WWW browser application. The Internet site, or URL, for the NASA/JSC Business Opportunities home page is http://prod.nais.nasa.gov/cgi-bin/eps/bizops.cgi?gr=D&pin=73
- Web Link
-
Click here for the latest information about this notice
(http://prod.nais.nasa.gov/cgi-bin/eps/bizops.cgi?gr=D&pin=73#115987)
- Record
- SN00830622-W 20050617/050615212556 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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