SOLICITATION NOTICE
99 -- Stability StudyTesting of Drug Substances
- Notice Date
- 7/13/2018
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541380
— Testing Laboratories
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, Nat'l Institute of Diabetes, Digestive, & Kidney Diseases, 2 Democracy Plaza, Suite 700W, 6707 Democracy Blvd., MSC 5455, Bethesda, Maryland, 20892-5455
- ZIP Code
- 20892-5455
- Solicitation Number
- NICHD-18-089
- Archive Date
- 7/26/2018
- Point of Contact
- Tina Robinson,
- E-Mail Address
-
robinsti@mail.nih.gov
(robinsti@mail.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 NICHD-18-089 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 2005-98. The North American Industry Classification (NAICS) Code is 541380 and the business size standard is $15m. 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) intends to contract on a sole source basis with PolyPeptide Group - 9395 Cabot Drive - San Diego, CA 92126 to continue providing the follow services: 1 Store and continue stability tests on GMP grade Acyline drug substance and vialed product. 2 Store and continue stability tests on GMP grade Metastin (Kisspeptin). 3 Store research grade Acyline. 4 Receive, store, ship and/or record compounds/products to a third party or NICHD at the written request of the Project Officer. This will be a Base + Four Option Periods agreement/order. Base Period P.O.P. is August 1, 2018 through 31 July 2019. In prior years, the NICHD Contraceptive Development Branch maintained R&D contracts for synthesis of peptides that could not be obtained through commercial sources. A highly effective peptide drug was developed under this program; Acyline, a long-acting GnRH antagonist. In addition, clinical grade (GMP) Kisspeptin (also known as Metastin) was manufactured. Government investment in manufacture, preclinical characterization and early clinical development of the agents resulted in advances in the field of reproductive biology. An injectable formulation of cGMP Acyline has been made available to qualified investigators. It has been used in multiple clinical trials in men and women and exhibits potent GnRH antagonism for up to 4 weeks with no evidence of histamine release. Similarly, cGMP Kisspeptin peptide was made available to qualified investigators for clinical studies. Additionally, as a service to the scientific community, PolyPeptide Inc. (formerly Neomps) continues to process requests for clinical grade Kisspeptin and Acyline, and research grade (non GMP) Acyline for animal studies by PIs in the USA and abroad. New manufacture of the drugs has been terminated; however, the existing supplies continue to be of considerable value to the research community. Importantly, the cost of maintaining and shipping these materials is very low compared to the prohibitive cost for individual researchers to have them synthesized on their own. Polypeptides has the required capability to properly store, test and manage shipment of clinical grade (GMP) materials and have capability to accurately measure out and distribute portion of bulk supplies. PolyPeptide Lab currently holds Government owned vials of clinical grade Acyline, bulk clinical grade Acyline and Metastin and bulk research grade Acyline. They are currently undergoing yearly stability testing protocol for these vials and bulk substance to support current and future clinical trials. There is an ongoing need for stability test of the clinical grade vialed and bulk Acyline and Metastin. This is to ensure that the drug substance or product is stable when it goes into clinical trial. These drug products must be stored at -20C and contracting and shipping them to another vendor is not cost effective. Failure to maintain these drug products would delay availability for use in clinical trials and add significant cost to the Government. PolyPeptide Lab has the expertise and capability to store, handle and perform stability testing of clinical grade samples. They have been the contractor providing service for these samples over several years and proven their capability to provide all the required services. They have performed all the stability tests for these samples, which provides confidence that the results may be compared. Movement of the materials to a new contractor would incur significant cost and raise concerns that future stability data for clinical compounds might not be comparable to historical data. 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. 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/products specified in this synopsis should submit a copy of their quotation to the following email address robinsti@mail.nih.gov. Offers must also be accompanied by descriptive literature, delivery/turnaround timeframe, warranties and other information that demonstrates that the offer meets all of the foregoing requirements. Quotations will be due eleven calendar days from the publication date of this synopsis or by July 23, 2018 by 9:00am EST. via email to robinsti@mail.nih.gov. The quotation must reference "Solicitation number" NICHD-18-089. Any questions must be sent via email to robinsti@mail.nih.gov and must include solicitation# NICHD-18-089 in the subject line of email. Faxed copies/responses will not be accepted. Note: In order to receive an award, contractor must be registered and have valid all awards certification in the SAM database @www.sam.gov at the time of closing of this RFQ.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/NIH/NIDDKD/NICHD-18-089/listing.html)
- Place of Performance
- Address: PolyPeptide Laboratories, 9395 Cabot Drive, San Diego, California, 92126, United States
- Zip Code: 92126
- Zip Code: 92126
- Record
- SN04990608-W 20180715/180713230644-107a0b10c7a81016127477894451e6de (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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