SOLICITATION NOTICE
R -- PREPARATION OF REGULATORY DOCUMENTS FOR SEROQUEL CLINICAL TRIAL
- Notice Date
- 9/3/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541618
— Other Management Consulting Services
- 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
- NIH-NIDDK-08-295A
- Archive Date
- 9/13/2008
- Point of Contact
- Tina Robinson, Phone: 301-402-8778
- E-Mail Address
-
robinsti@mail.nih.gov
- Small Business Set-Aside
- Total Small Business
- 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-08-295A, 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 2005-26. The North American Industry Classification (NAICS) Code is 541618 and the business size standard is $6.5M. This acquisition is being conducted using Simplified Acquisition Procedures in accordance with FAR Part 13. The National Institutes of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to contract on a sole source basis with Fast Track Drugs and Biologies, 5 Paramus CT, Gaithersburg, MD 20878. Fast Track will prepare regulatory documents, maintain sponsor’s regulatory files for the course of the Seroquel Clinical Trail Study. This is an on-going study between The National Institute on Alcohol Abuse and Alcoholism (NIAAA) AstraZeneca.. This study involves human participants which are already enrolled in the study. Fast Track has access to NIAAA’s study materials to maintain regulatory documents for the Seroquel Trail. Fast Track developed the protocol for the current multisite study and developed the system and infrastructure for Serious Adverse Events (SAE) recording and reporting during this study. Fast Track is the organization who filed the Investigational New Drug Applications (IND) with the FDA for quetipine (Seroquel XR® ), which is the study drug being evaluated in the ongoing study. Also, they are named in the Clinical Trails Agreement (CTA) with AstraZeneca as NIAAA’s agent responsible for preparing and submitting all required reports/regulatory documents. Fast Track is the sole coordinator for the receipt, review and transmission of SAEs to the FDA and AstraZeneca. 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. This notice of intent is not a request for competitive quotations however, all responses received, within 10 days from the date of publication of this synopsis will be considered by the Government. 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 in 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.arnet.gov/far. Interested vendors capable of furnishing the government with the service specified in this synopsis should submit two (2) copies of their quotation to the below address. Quotations will be due ten (10) calendar days from the publication date of this synopsis or by September 12, 2008, 3pm Eastern Standard Time. The quotation must reference “Solicitation number” NIH-NIDDK-08-295A. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. Quotations must be submitted in writing to the National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd., Room 774B, Bethesda, Maryland 20817, Attention: Tina Robinson. Faxed copies will not be accepted. Email copies will not be accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=c3bd9ffdedaf7b36855766bef8a6f23d&tab=core&_cview=1)
- Record
- SN01657679-W 20080905/080903222140-c3bd9ffdedaf7b36855766bef8a6f23d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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