SOURCES SOUGHT
68 -- Drug Synthesis - Solicitation
- Notice Date
- 7/21/2014
- Notice Type
- Sources Sought
- NAICS
- 325411
— Medicinal and Botanical Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- 1133843
- Archive Date
- 8/12/2014
- Point of Contact
- Crystal G. McCoskey, Phone: 8705437267
- E-Mail Address
-
crystal.mccoskey@fda.hhs.gov
(crystal.mccoskey@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Solicitation MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION This is a sources sought to determine the availability and capability of small businesses to provide drug synthesis. The associated North American Industry Classification System (NAICS) Code is‐ 325411, Medicinal and Botanical Manufacturing; Small Business Size Standard is 750 employees. Part I: General Information (Introduction/Background/Scope) The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) has a requirement for the synthesizing of 38 drugs with an option for up to 50 additional drugs. The Liver Toxicity Knowledge Base (LTKB) is an ongoing research project within the Division of Bioinformatics & Biostatistics at NCTR. Drug-Induced Liver Injury (DILI), being one of the most common reasons for early termination of drug development and post-marketing regulatory actions, continues to be a major challenge in the drug development process and the regulatory decision making. The occurrence of clinically serious DILI events, such as Acute Liver Failure (ALF) of marketed drugs followed by regulatory action of withdrawal or black boxed warning illustrates the inadequacy of the current testing strategy to accurately identify culprit agents. Several plausible explanations have been offered for the difficulty of detecting drugs with DILI potential in preclinical and clinical studies. In vitro hepatocyte-based systems provide the opportunity to test these sDILI drugs with biological endpoints to gain insight into the possible mechanisms involved. The data generated and knowledge obtained can empower LTKB to help FDA regulators as well as industrial to better assess drug candidates' potential to cause sDILI. Historically, there were about 50 withdrawn drugs due to sDILI. However, majority of these drugs are no longer available commercially due to safety concerns. The only way to obtain these drugs is de novo synthesis; hence the need for the 38 and potentially 50 more, withdrawn or black boxed warning drugs to be synthesized. Part II: Work Requirements The Contractor shall, following the industry's good practices and Standard Operating Procedures (SOPs), provide the 38 synthesized drugs and 50 optional drugs. The SOPs shall be provided to maintain the synthesized steps for auditing purposes. Each drug shall be accompanied with a hard copy Certificate of Conformance (COC) identifying the drug and the purity demonstrated using at least one verification technique, such as Hydrogen-1 Nuclear Magnetic Resonance (HNMR), Carbon-13 NMR (CNMR), Liquid Chromatography-Mass Spectrometry (LC-MS), High-performance liquid chromatography (HPLC) and Gas Chromatography-Mass Spectrometry (GC-MS). In addition to hard copy, the COCs and all other relevant technical information, concerning the lot of drugs in each shipment, shall be sent to the Contracting Officer's Representative (COR) once the drugs are shipped. Part III: Supporting Information A. Delivery Address: U.S. FDA National Center for Toxicological Research Attn: Jie Zhang 3900 NCTR Rd., Building 53C, Rm 109A Jefferson, AR 72079 B. Period of Performance The period of performance shall be for one (1) year from award date with up to one option year. The initial delivery of the first 10 drugs shall be within three months of contract award date with 10 drugs delivered every three months thereafter until all 38 drugs have been delivered. The option period deliveries, if exercised, shall be 13 drugs every three (3) months until all 50 are delivered. List of Required Drugs 0001 - Base Quantity, 38 synthesized drugs as identified below and in accordance with the scope above: LTKB# Compound_name Structure LT02100 Amfetamine LT02041 Dicloxacillin LT02033 Ximelagatran LT02028 Flucloxacillin LT01867 Xenazoic acid LT01858 Tetrabamate LT01854 Nitrefazole LT01846 Fenclozic acid LT01822 Tolrestat LT01816 Suloctidil LT01680 Pirprofen LT01508 Mebanazine LT01488 Levofloxacin LT01371 Fialuridine LT01359 Exifone LT01318 Droxicam LT01228 Clometacin LT01219 Cinchophen LT01121 Benziodarone LT01120 Benzarone LT01117 Bendazolic acid LT01060 Alpidem LT00703 Phenoxypropazine LT00700 Phenisatin LT00697 Pipamazine LT00696 Isaxonine LT00694 Clomacran LT00692 Alclofenac LT00691 Tilbroquinol LT00632 Sulfathiazole LT00560 Ibufenac LT00513 Benoxaprofen LT00461 Alatrofloxacin LT00131 Perhexiline LT00112 Dilevalol LT00109 Iproniazid LT00045 Amineptine 0002 - Option Quantity, 50 synthesized drugs as identified below and in accordance with the scope above: LTKB# Compound_name Structure LT01042 Acitretin LT00618 ambrisentan LT00693 aplaviroc LT00917 atracurium LT00817 biperiden LT00058 bupropion LT01160 carbidopa LT01167 cefadroxil Comb. cotrimoxazole LT01250 cyclofenil LT00380 cyclosporin LT00083 dextropropoxyphene LT01849 ebrotidine LT01153 ezetimibe LT01870 falnidamol LT00097 felbamate LT00701 fiduxosin LT00179 fluconazole LT00018 fluoxetine LT00477 gemtuzumab not available LT02092 glafenine LT01446 Indinavir LT00111 ketoconazole LT00576 lovastatin LT00686 lumiracoxib LT02110 mepazine LT01555 mianserin LT00416 minocycline LT00588 mitomycin LT00124 nefazodone LT01594 nialamide LT01602 niperotidine LT00690 oxyphenisatine LT01648 Phenoxymethylpenicillin LT00134 pioglitazone LT00698 pralnacasan LT00186 pravastatin LT01746 saquinavir LT00625 sertraline LT00699 sulfacarbamide LT00448 tacrolimus LT00982 tamsulosin LT00687 tasosartan LT00636 ticrynafen LT01220 tipranavir LT00158 toremifene LT00168 troglitazone LT01869 zafirlukast LT01874 zimelidine Section II: Instructions to Prospective Respondents Responses to this sources sought shall unequivocally demonstrate that respondent has the capability to provide the drug synthesis. Though the target audience is small businesses capable of performing the synthesis, any interested party may respond. At a minimum, responses shall include the following: • Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, 8(a), SDB, WOSB, EDWOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address; • Information on the equipment, personnel and methods to be used to conduct the synthesis; • Three (3) years of past performance information for the service of same or substantially similar items, to include date of services, description (should also include technical literature and drug list), dollar value, client name, client address, client point of contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, and client point of contact email address; • Descriptive literature, brochures, specifications, marketing material, etc. detailing the nature of the products the responding firm is regularly engaged in providing; • If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this requirement; • If a large business, identify the subcontracting opportunities that would exist for small business concerns; • Although this is not a request for quote, informational pricing is encouraged; • The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation. The Government is not responsible for locating or securing any information, not identified in the response. Interested Parties 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 28, 2014 by 1:00 PM (Central Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OA/OAGS, Attn: Crystal G. McCoskey, 3900 NCTR Road, Bldg 50/Room 426, HFT‐320, Jefferson, AR 72079‐9502 or email crystal.mccoskey@fda.hhs.gov. Reference 1133843 in all correspondence with the point of contact listed above. Notice of Intent Responses to this sources sought announcement will assist the Government in determining whether this requirement should be set aside for small business, made available to full and open competition or procured through other than full and open acquisition procedures. 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 combined synopsis/solicitation (No. 1133843) may be published via 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).
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-
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- Record
- SN03431895-W 20140723/140721234851-0324444fa1be040c6fbfbfe48e5cf3d2 (fbodaily.com)
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