SOURCES SOUGHT
68 -- unlabeled and isotopically-labeled oseltamivir phosphate and oseltamivir carboxylate
- Notice Date
- 7/12/2012
- Notice Type
- Sources Sought
- NAICS
- 325199
— All Other Basic Organic Chemical Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, Bldg 50 Room 422, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1107236
- Archive Date
- 7/31/2012
- Point of Contact
- Nicholas E Sartain, Phone: 870-543-7370
- E-Mail Address
-
nick.sartain@fda.hhs.gov
(nick.sartain@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), is conducting market research to support the National Center for Toxicological Research (NCTR) requirement for unlabeled and isotopically-labeled oseltamivir phosphate and oseltamivir carboxylate. The FDA is seeking business sources, including total small businesses, service-disabled veteran-owned small businesses, HUBZone small businesses, 8(a) certified companies and other than small businesses. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort. The government is seeking capability statements from manufacturing businesses capable of meeting the performance requirements. The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Laboratory of Mass Spectrometry within the Division of Biochemical Toxicology is responsible for the conduction of mass spectral analyses aiming to clarify the pharmacokinetic profiles of oseltamivir, the active principle of the antiviral drug Tamiflu in pregnant and non-pregnant animal models in support of a Medical Countermeasures Initiative-sponsored protocol. In order to accomplish this task the laboratory needs to procure unlabeled and isotopically-labeled oseltamivir phosphate and oseltamivir carboxylate. These standards will be used to develop a liquid chromatography - isotope dilution tandem mass spectrometry methodology for the quantification of these compounds in plasma samples. Performance Requirements: The following standards will be required: 100 mg - Oseltamivir phosphate [CAS 204255-11-8; (3R,4R,5S)-4-(Acetylamino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid ethyl ester phosphate)]. Chemical purity ≥98%. 20 mg - Labeled oseltamivir phosphate. Chemical purity ≥98%. The molecule must be labeled with a minimum of 3 deuterium atoms (2H) in stable positions or a minimum of 3 carbon 13 (13C), with a minimum isotopic purity of 99%. 50 mg - Oseltamivir carboxylate [CAS 187227-45-8; (3R,4R,5S)-4-(Acetylamino)-5-amino-3-(1-ethylpropoxy)-1-cyclohexence-1-carboxylic acid] - minimum chemical purity of 98% 20 mg- Labeled oseltamivir carboxylate - Chemical purity ≥98%. The molecule must be labeled with a minimum of 3 deuterium atoms (2H) in stable positions or a minimum of 3 carbon 13 atoms (13C), with a minimum isotopic purity of 99%. Each standard should be supplied in no more than 4 separate vials in order to minimize sample losses inherent to sample transfer procedures. FOB Point Destination. To be delivered no later than 30 calendar days after receipt of order (ARO) FOB Point of Delivery for Services and Supplies will be the FDA/NCTR located at 3900 NCTR Road, Jefferson, AR 72079. Payment terms net 30 days after government acceptance. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offeror is capable of providing the required products identified above. Firms believing they can meet the requirements to the above specifications are encouraged to respond electronically with no less than the following information: • Business name, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; • Sufficient descriptive literature that unequivocally demonstrates that offered products meet the specifications. • At a minimum provide the following: All descriptive material necessary for the government to determine whether the product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement. Indicate whether the organization is the manufacturer of the items or authorized reseller. If reseller, include the manufacturer's name, address and DUNS number. • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested. • Provide comments on draft performance requirements and if any of these specifications are too restrictive or vague. No response will be considered that the listed specifications are adequate in a competitive acquisition. • If a large business, provide if subcontracting opportunities exist for small business concerns. • Suggestions on applicable NAICS code for this requirement. • Though this is not a request for quote, informational pricing must be submitted. The government is not responsible for locating or securing any information, not identified in the response. The associated North American Industry Classification System (NAICS) Code is- 325199- All Other Basic Organic Chemical Manufacturing; Small Business Size Standard is 1,000 employees. Interested Contractors must respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before July 16, 2012 by 10:00 A.M. (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email nick.sartain@fda.hhs.gov. Reference FDA1107236. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures. The FDA is also conducting this market research to determine if these products are available domestically at a fair and reasonable cost to the Government. 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 to allow the Government to determine the organization's qualifications to perform the work. 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. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in FedBizOpps. However, responses to this notice will not be considered adequate 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).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/NCTR/FDA1107236/listing.html)
- Place of Performance
- Address: 3900 NCTR Road, Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN02801301-W 20120714/120712235707-06b43a8b6aca05b1581aee029d829178 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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