FILE | B | rhesus monkey study - statement of work

FBO DAILY ISSUE OF JUNE 20, 2008 FBO #2398
DOCUMENT

B -- rhesus monkey study - statement of work

Notice Date: 6/18/2008
Notice Type: statement of work
NAICS: 541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
Contracting Office: Department of Health and Human Services, Food and Drug Administration, Office of Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
ZIP Code: 72079-9502
Solicitation Number: FDA-SOL-08-00764
Archive Date: 7/8/2008
Point of Contact: Nicholas E Sartain,, Phone: 870-543-7370
E-Mail Address: nick.sartain@fda.hhs.gov
Small Business Set-Aside: Total Small Business
Description: This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This requirement is being issued in conjunction with FAR 13.5 Simplified Acquisition Procedures, as applicable. The solicitation number is FDA-SOL-08-00764. This solicitation is issued as a Request for Proposal (RFP) and is set aside for small business concerns. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-26. The associated North American Industry Classification System (NAICS) Code is-541712- Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology); Small Business Size Standard is 500 employees. The Food and Drug Administration is soliciting for a contract research organization (CRO) with the capability of conducting nonhuman primate research to provide, dose and sample the required animals. The FDA/National Center for Toxicological Research has been conducting a toxicokinetic study with intravenous and oral dosing of emulsions of di(2-ethylhexyl) phthalate in neonatal male rhesus monkeys, which is a prelude to a subchronic toxicity study. The nonhuman primate colony at NCTR has a limited number of active Indian origin rhesus female breeders and all are of Indian origin. The toxicokinetic study has been conducted with neonatal males from our breeding colony. The subchronic study will involve a relatively large number of animals and there are also other studies with neonatal monkeys at NCTR. NCTR’s current number of breeders will not be sufficient to supply the needs of the planned studies. NCTR is considering changing to Chinese-origin rhesus monkeys for the subchronic study. Before making a final decision on this, a comparison toxicokinetic study with neonatal Chinese origin males will be conducted to confirm the suitability of Chinese-origin rhesus monkeys. The contract lab will dose the animals and collect blood samples that will be sent to NCTR for analysis. NCTR would prepare and certify the doses and treatment and sample collection protocols. The study will involve three(3) animals each treated with three single iv doses over the first nine weeks of life (one injection on postnatal day 5, one injection during week 5, and on injection during week 9), followed by a single oral dose during week 10. NCTR’s study was conducted according to this protocol and the contract organization shall follow this requirement. See the attached statement of work for study requirements. Contract Type: Commercial Item-Firm Fixed Price. Simplified acquisition procedures will be utilized. FOB Point destination. To be delivered as outlined in the attached statement of work. FOB Point of Delivery for Services and Supplies will be the FDA/NCTR located at 3900 NCTR Road, Jefferson, AR 72079-9502. Payment terms net 30 days. Standard commercial warranty is required if applicable. The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: (i) Technical capability of the items offered to meet the Government’s requirement. (ii) Past Performance (iii) Price. Technical acceptability will be determined by review of information submitted by the offeror which must provide a description in sufficient detail to show that the offeror has the capability to perform the required services which demonstrates knowledge of the requirement to meet the Government's requirement. Past Performance Identify two federal, state, local government, or private contracts for which the offeror has performed work similar to the SOW in this solicitation (include contracts within the last two years, point of contact, and telephone numbers). The government reserves the right to make an award without discussions. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the product and/or service meets the technical requirements. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, applies to this acquisition. Offerors shall complete and return a copy of the provision at FAR 52.212-3, Offeror Representations and Certifications - Commercial Items with their offer. If the end product(s) offered is other than domestic end product(s) as defined in the clause entitled "Buy American Act-Supplies," the offeror shall so state and shall list the country of origin. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. The following agenda have been attached to the clause. None. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.222-50, 52.225-1, 52.225-13, and 52.232-33. The following additional provisions and/or clauses apply: 52.204-7. Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.arnet.gov/far/ CCR Requirement - Company must be registered in the Central Contractor Registration (CCR) system before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit an offer, which if timely received, shall be considered. The offer must reference solicitation number FDA-SOL-08-00764. The Offers are due in person, by postal mail, fax or email to the point of contact listed below on or before June 23, 2008 by 13:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OSS/OFFAS, Attn: Nick Sartain, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. For information regarding this solicitation, please contact Nick Sartain at (870) 543-7370, FAX (870) 543-7990 or email nick.sartain@fda.hhs.gov.
Web Link: FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=212bd0011cb31e889cbc76ddb58d0ba4&tab=core&_cview=1)
Document(s): statement of work; File Name: statement of work (NCTRChineseOrigin.doc); Link: https://www.fbo.gov//utils/view?id=1521cfd173731837694947a540eec1bd; Bytes: 36.50 Kb; Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
Place of Performance: Address: 3900 NCTR Rd, Jefferson, Arkansas, 72079, United States; Zip Code: 72079
Record: SN01595737-W 20080620/080618215351-212bd0011cb31e889cbc76ddb58d0ba4 (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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B -- rhesus monkey study - statement of work