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Q--Intravesicular Toxicity and TK Study

  Miranda Ave Palo Alto, CA United States — Department of Veterans Affairs, VA Palo Alto Health Care System
Published August 25, 2015 — Deadline August 28, 2015 (4 years ago)
Notice type
Contract notice
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice in conjunction with procedures in FAR Part 13. This announcement constitutes the only solicitation; a written solicitation will not be issued. The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b)(1). Interested persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of intent is not a request for competitive proposals. However, all proposals received prior to 08/28/2015 will be considered by the Government. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. The solicitation number, VA261-15-Q-0876 is issued as a Request for Quotation (RFQ). This document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-83 effective July 2, 2015 and Veterans Affairs Acquisition Regulation Supplement (VAAR) current to December 27, 2012. The North American Industry Classification System (NAICS) Code for this acquisition is 112990, Size Standard: $0.75. Requirement Description: Item Information ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 Intravesicular Toxicity and TK study of PLZ-4 Coated Paclitaxel loaded micelles in female rats 1.00 EA __________________ __________________ 0002 Bioanalytical LC/MS-MS Method Transfer and GLP validation (paclitaxel; rats) 1.00 EA __________________ __________________ 0003 HPLC Method transfer and glp validation 1.00 EA __________________ __________________ 0004 Dose formulation sample analysis (2 intervals) LOCAL STOCK NUMBER: 3550 1.00 EA __________________ __________________ 0005 Test article return to VA Research lab 1.00 EA __________________ __________________ 0006 TK sample analysis (120 TK samples) plus modeling 1.00 EA __________________ __________________ GRAND TOTAL __________________ PERFORMANCE STATEMENT OF WORK Intravesicular Toxicity and TK Study of PLZ-4 Coated Paclitaxel Loaded Micelles in Female Rats " Bioanalytical LC/MS-MS Method Transfer and GLP Validation (Paclitaxel; Rats) " HPLC Method Transfer and GLP Validation " TK Sample Analysis (60 TK samples) plus modeling " Dose Formulation Sample Analysis (2 Intervals) " Test Article Return to Investigator The following is the outline for this study, which is in 2 parts: Species used will be Sprague-Dawley Rats, female rats will be used, vendor is required to have GLP status, rats will have 1 week acclimation period prior to study. " Toxicity study " 10 female rats per groups ( 4 groups, and 40 rats total) " Long term 5 female rats per groups (4 groups, and 20 rats total) o Group 1: empty micelle, Group 2: Alb Paclitaxel , Group 3: PTX-loaded micelle, 4: PBS " Treatment : o Rats are treated with intravesicular administration of drugs for 2 hours (under general anesthesia) o Once per week for a total of 6 weeks o Observe 2 times/day, clinical observation: 1/week; body weight: 1/day, food consumption weekly o On day 15 (after 3rd dose) and on day 57: check CBC/biochemistry panel/UA o On day 57: full necropsy, collect, weight, histopath (reviewed by ACVP pathologists) " Recover: 4 weeks post last treatment (5 rats each group) " Standard GLP report " TK study " 9 female rats with jugular vein catheter (2 groups, 18 rats total) o Group 1: Alb-PTX 2: PTX-loaded micelle " Treatment: o Six doses: 3mg/ml (300 ul) intravesically administrated once per week o Collect blood at 5, 15, 30 min, 1, 2, 4, 8, 16, and 24 and 48 hours post injection for detection of PTX absorption; 60 total samples (3 rats for each time point) o Detection of PTX absorption at dose 1 and dose 6 " TK sample analysis (60TK) plus modeling " Dose formulation sample analysis (twice) " Full necropsy, full tissue collection and standard organ weights collected on all animals in all groups " A full list of tissues from all animals in all groups will be processed to slides and evaluated. " Full report ready for IND filing, to be provided at end of study period. FAR Number Title Date 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (APR 2014) 52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL ITEMS (DEC 2014) 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (MAY 2015) For the purposes of this clause items (b) 4, 6, 8, 25,27, 28,30, 33, 40, 42, 51 are considered checked and apply. 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/ 52.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012) (a) Definitions. As used in this clause- (1) Contract financing payment has the meaning given in FAR 32.001. (2) Designated agency office has the meaning given in 5 CFR 1315.2(m). (3) Electronic form means an automated system transmitting information electronically according to the Accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests. (4) Invoice payment has the meaning given in FAR 32.001. (5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract. (b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required. (c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following: (1) VA's Electronic Invoice Presentment and Payment System. (See Web site at http://www.fsc.va.gov/einvoice.asp.) (2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org) includes additional information on EDI 810 and 811 formats. (d) Invoice requirements. Invoices shall comply with FAR 32.905. (e) Exceptions. If, based on one of the circumstances below, the contracting officer directs that payment requests be made by mail, the contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for: (1) Awards made to foreign vendors for work performed outside the United States; (2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information; (3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies; (4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or (5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above. (End of Clause) VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008) The bidder or offeror agrees that if a contract is awarded to him/her, as a result of this solicitation, he/she will not advertise the award of the contract in his/her commercial advertising in such a manner as to state or imply that the Department of Veterans Affairs endorses a product, project or commercial line of endeavor. (End of Clause) VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984) The contractor shall obtain all necessary licenses and/or permits required to perform this work. He/she shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. He/she shall be responsible for any injury to himself/herself, his/her employees, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by his/her employees fault or negligence, and shall maintain personal liability and property damage insurance having coverage for a limit as required by the laws of the State of California. Further, it is agreed that any negligence of the Government, its officers, agents, servants and employees, shall not be the responsibility of the contractor hereunder with the regard to any claims, loss, damage, injury, and liability resulting there from. Contracting Office Address: Department of Veterans Affairs; VISN 21 3801 Miranda Avenue Palo Alto, CA 94304 Primary Point of Contact: Lupe Arroyo Isabel.arroyo@va.gov 650-849-0386

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Fact Sheet

Department of Veterans Affairs
VA Palo Alto Health Care System
Department of Veterans Affairs Palo Alto Health Care System
Department of Veterans Affairs;VA Sierra Pacific Network (VISN 21);VA Palo Alto Health Care System (90/NCA);3801 Miranda Ave;Palo Alto CA 94304-1207
Q--Intravesicular Toxicity and TK Study
Lupe Arroyo
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice in conjunction with procedures in FAR Part 13. This announcement constitutes the only solicitation; a written solicitation will not be issued.

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