SOLICITATION NOTICE
B -- large scale synthesis of compound
- Notice Date
- 8/3/2017
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325199
— All Other Basic Organic Chemical Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch, 6710B Rockledge Dr., Suite 1124, MSC7000, Bethesda, Maryland, 20892-7510, United States
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NIDDK-17-213
- Archive Date
- 8/29/2017
- Point of Contact
- Amber Harris, Phone: 3014028778
- E-Mail Address
-
amber.harris@nih.gov
(amber.harris@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation number is NIH-NIDDK-17-213 and is issued as a Request for Quotation (RFQ). The solicitation/contract will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2005-95. The North American Industry Classification (NAICS) Code is 325199 and the business size standard is 1,250. However, this solicitation is not set aside for small business. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intend to procure on a sole source basis with American Biochemicals, Inc. of 2151 Harvey Mitchell Pkwy South, #221 College Station, TX 77840 for the purchase of a large scale [100 gram] synthesis of compound NCGC00351982 (KU130) CAS number 1842323-83-4. The National Institute of Digestive, Diabetes & Kidney Diseases's (NIDDK) Liver Diseases Branch [LDB] has made the discovery that the novel organic compound, NCGC00351982 (KU130) CAS number 1842323-83-4, holds the potential for therapeutic properties against HBV infection. The LDB has gone as far as it can go in researching these effects and would now like to begin the process of FDA approval to clinical trials. In order to begin the submission process to the FDA, a significant number of further tests will need to be performed in multiple species, and by multiple vendors [for validation]. All of this testing will consume a large quantity of the compound [at least 100g worth]. So, the LDB needs to have synthesized 100g of the compound. Further, due to FDA regulations, the compound must be essentially identical in each of the testing, with mass spec/HPLC documentation for the samples used. This would best be accomplished by having only one vendor synthesize the compound. Furthermore, it would be best to utilize a company that has experience in synthesizing substituted oxazole compounds and can synthesize it in large quantities. Compound NCGC00351982 (KU130) was previously provided to the LDB in a small quantity as part of a screening panel so AMERICAN BIOCHEMICALS has prior experience with it. This vendor is the only one able to perform all the various tests themselves, without having to go to multiple vendors. In addition, this work is a continuation of a project that was performed using their synthesized version of this compound, and if the NIDDK was to go to another vendor, the results might not be able to be correlated, and all the LDB's tests would need to be repeated to satisfy FDA regulations. In the light of the NIDDK's ongoing studies, consistency and continuity of research goals requires the utilization of AMERICAN BIOCHEMICALS' deliverables. The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under authority of the 41 U.S.C. 253(c) (1), FAR 6.302. Only one responsible source and no other supplies or services will satisfy agency requirements. The offeror must include a completed copy of the provision of FAR Clause 52.212-3, Offeror Representations and Certifications - Commercial Items with its offer. The provisions of FAR Clause 52.212-1 Instructions to Offerors - Commercial Items; FAR Clause 52.212-2, Evaluation - Commercial Items; FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items; and FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items - Deviation for Simplified Acquisitions applies to this acquisition. The offeror must include their Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. The clauses are available in full text at http://www.acquisition.gov/far/. Interested vendors capable of furnishing the government with the services specified in this synopsis should submit a copy of their quotation to the below address or via email to amber.harris@nih.gov. Offers must also be accompanied by descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all of the foregoing requirements. Quotations will be due on or before August 14, 2017 by 10 am, EST. via email or postal mail. The quotation must reference "Solicitation number" NIH-NIDDK-17-213. Quotations sent by postal mail or other mailing services must be submitted to the following address: Eunice Kennedy Shriver National Institute of Child Health and Human Development, 6710B Rockledge Drive, Room 1159A, Bethesda, MD 20817. Attention: Amber Harris, by the date and time mentioned above. Any questions must be sent via email to amber.harris@nih.gov and must include solicitation#NIH-NIDDK-17-213 in the subject line of email. Faxed copies/responses will not be accepted. PLEASE NOTE: In order to receive an award, contractor must be registered for "All Awards" and have a valid certification in the System for Award Management (SAM) database at http://www.sam.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NICHD/NIH-NIDDK-17-213/listing.html)
- Place of Performance
- Address: BETHESDA, Maryland, 20892, United States
- Zip Code: 20892
- Zip Code: 20892
- Record
- SN04610302-W 20170805/170803231708-836de85b468750a09d42410ada9f1a7d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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