FILE | 68 | API Trazodone Hydrochloride USP - Attachment

FBO DAILY ISSUE OF MAY 31, 2012 FBO #3841
DOCUMENT

68 -- API Trazodone Hydrochloride USP - Attachment

Notice Date: 5/29/2012
Notice Type: Attachment
NAICS: 325998 — All Other Miscellaneous Chemical Product and Preparation Manufacturing
Contracting Office: Department of Veterans Affairs;Carlos Jaquez, Contract Specialist;SAO West VISN 18 NCO;5001 N Piedras St;El Paso TX 79930-4210
ZIP Code: 79930-4210
Solicitation Number: VA25812Q0466
Response Due: 6/12/2012
Archive Date: 9/10/2012
Point of Contact: Carlos Jaquez
E-Mail Address: Contract Specialist
(carlos.jaquez@va.gov)
Small Business Set-Aside: N/A
Description: 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. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation VA258-12-Q-0466 is issued as a Request for Quote (RFQ). Solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-57. The NAICS code is 325998 and the size standard is 500 employees. STATEMENT OF WORK (SOW) CONTRACT TITLE: Purchase of active pharmaceutical ingredient (API), Trazodone Hydrochloride, United States Pharmacopeia (USP). The VA Cooperative Studies Program will use this API to manufacture 25 and 75 milligram capsules for use in the P313 Clinical Research Trial (study). BACKGROUND: The VA Cooperative Studies Program is the Division of VA Research and Development responsible for the planning and conduct of large multicenter clinical trials and epidemiological studies in the Department of Veterans Affairs. The VA Cooperative Studies Program needs a company to manufacture the active pharmaceutical ingredient (API), Trazodone Hydrochloride, USP. CSPCRPCC will use this API to make 25 and 75 milligram capsules to be taken by active duty and veteran patients participating in the P313 Research Study for the "Determination of Efficacy of Trazodone Hydrochloride, Quetiapine Fumarate (Seroquel), and Eszopiclone (Lunesta) Versus Placebo for the Treatment of Sleep Disturbance in Service Members and Veterans with PTSD." SCOPE: The company manufacturing the API (Trazodone Hydrochloride, USP) must have a Drug Master File (DMF) on file with the U.S. Food and Drug Administration (FDA). The DMF demonstrates to the FDA how the manufacturer meets the regulatory, processing, quality and safety requirements for manufacturing the API. The study Sponsor, the Office of the Surgeon General, Department of the Army (Army), must submit an Investigational New Drug Application (IND) to the FDA to obtain permission to conduct the P313 Study. The information contained in the DMF assures the FDA employee reviewing the IND that the API used to make the clinical research product is made under the appropriate regulatory, process, quality and safety conditions. The CSPCRPCC needs to immediately purchase one 40Kg drum of the API to manufacture 25 and 75 milligram capsules for use in the P313 Study. The first drum of API is needed immediately because the FDA met with Army and VA CSP representatives in late March. The FDA told the Army they need to conduct an "in vivo bioequivalence study" using the drug the CSP CRPCC will manufacture. The bioequivalence study must be completed prior to the start of the P313 study which is scheduled to start January 1, 2013 and must use the 75mg capsules manufactured by the CSP CRPCC. The CSP CRPCC must receive the API no later than July 20, 2012 to allow enough time to formulate, manufacture, bottle, label, package, and ship the Trazodone Hydrochloride capsules to the contractor performing the bioequivalence study, wait for the completion of the bioequivalence study and then manufacture, bottle, label, package and ship the 25 and 75 milligram capsules to the clinical locations participating in the P313 Study so they can dispense the product to patients starting January 1, 2013. The bioequivalence study requirement was not expected and was thus not included in the timeline for manufacturing the product. Any delay obtaining the first 40Kg drum of API Trazodone Hydrochloride, USP product will seriously impact the mission of the Cooperative Studies Program, the Army and the health of the veterans and active duty service men and women enrolled in this research study by delaying research designed to prevent sleep disturbances resulting from PTSD. The research study budget which includes providing veteran and active service patients with drug product also includes hiring and training employees, and is based upon starting the veteran and active service patients on the drug beginning January 1, 2013. The CSPCRPCC expects to purchase a second 40Kg drum of the API (Trazodone Hydrochloride, USP) in the fourth quarter of Fiscal Year 2013 and a third 40Kg drum of the API (Trazodone Hydrochloride, USP) in the fourth quarter of Fiscal Year 2014 in order to continue manufacturing the 25 and 75 milligram capsules for the completion of the P313 Study. The CSPCRPCC needs to purchase each additional drum of product approximately 12 months after receipt of the previous drum. The API expiration dating impacts the timing of the purchases. The CSPCRPCC must manufacture and package the 25 and 75 milligram capsules for distribution to patients from the start of the study through the last day a patient is enrolled. This requires multiple manufacturing runs. Purchasing the API (Trazodone Hydrochloride, USP) in FY12, FY13 and again in FY14 provides additional assurance that the finished dosage form's expiration date will stay good through the end of the P313 Study. SPECIFIC TASKS: a.The manufacturer must have a current Drug Master File (DMF) for the API (Trazodone Hydrochloride, USP), on file with the FDA that is applicable to the manufacture on the API (Trazodone Hydrochloride, USP). b.Only product made by manufacturers listed on the FDA's Drug Master File under 'Trazodone Hydrochloride' is acceptable. oThe FDAs DMF list can be found at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/default.htm oSearch for the DMF Zip file, open it, and sort for 'Trazodone Hydrochloride,' under subject c.The manufacturer (or their US distributor/agent) must agree to provide a Letter of Authorization to the FDA, allowing the FDA to refer to all pages of the DMF applicable to the manufacture of the API (Trazodone Hydrochloride, USP) to support the Investigational New Drug (IND) application for the P313 clinical research trial. d.The manufacturer (or their US distributor/agent) must agree to provide an original signed copy of the Letter of Authorization to the VA CSP CRPCC and/or the Army for inclusion in the IND submission to the FDA. e.The manufacturer of the API (Trazodone Hydrochloride, USP) must provide documentation that either the FDA or the European Union (EU) Authorities conducted a recent, successful FDA or EU inspection of the facility in which the API (Trazodone Hydrochloride, USP) is manufactured, preferably for the manufacturing process used to manufacture the API (Trazodone Hydrochloride, USP). f.The API (Trazodone Hydrochloride, USP) must have a minimum expiration date of 55 months remaining upon receipt at the CSPCRPCC. g.The manufacturer (or their US distributor/agent) must handle all interactions with US Customs for exporting the API product from the country of origin and importing it to the US. h.The manufacturer (or their US distributor/agent) must include all Customs Broker, US Customs and shipping/delivery fees in the price of the API (Trazodone Hydrochloride, USP) product. i.The manufacturer (or their US distributor/agent) must handle all interactions with Export and/or Import Brokers for the export of the product from the country of origin and for import into the US. j.The manufacturer (or their US distributor/agent) must include all Export and/or Import Broker fees in the price of the API (Trazodone Hydrochloride, USP) product. k.The manufacturer (or their US distributor/agent) must include all shipping and delivery fees from the manufacturer to delivery at the CSPCRPCC in the price of the API (Trazodone Hydrochloride, USP). l.The manufacturer (or their US distributor/agent) must provide a Certificate of Analysis showing that the API (Trazodone Hydrochloride, USP) meets the USP specifications for each lot of the API (Trazodone Hydrochloride, USP) manufactured for purchase by the CSPCRPCC. oThe CSPCRPCC Laboratory will perform analytical (verification) testing of the API against at least the identification and potency specifications. PERFORMANCE MONITORING: Refer to the Quality Assurance Surveillance Plan. SECURITY REQUIREMENTS: The C&A requirements do not apply and that a Security Accreditation Package is not required. PERIOD OF PERFORMANCE: The period of performance for this contract is for a Base Year plus Two Option Year. DEFINITIONS/ACRONYMS: a.API - The active pharmaceutical ingredient in a dosage form or experimental drug that is expected to cure or minimize the symptoms of the disease the patient is experiencing. b.BLINDED PRODUCT - Experimental drug and placebo manufactured so the experimental drug looks like the placebo and the patients cannot tell whether they are taking the experimental drug or the placebo. c.CLINICAL INVESTIGATOR - A medical researcher in charge of carrying out a clinical trial's protocol. d.CLINICAL TRIAL - A clinical trial is a research study to answer specific questions about vaccines or new therapies or ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. e.CO - Contracting Officer. The Federal employee who is warranted by the Government to enter into contracts on behalf of the Government and is the only person authorized to make changes to those contracts. f.COR - Contracting Officer's Representative. Individual designated by the CO to place orders, furnish technical guidance, advice, certify invoices, and provide general supervision of the work performed under the executed contract. g.CSPCRPCC - Cooperative Studies Program Clinical Research Pharmacy Coordinating Center h.CUSTOMS BROKER - The Customs Broker prepares the documents and/or electronic submissions, the calculation (and the payment) on behalf of the client, of taxes, duties and excises, and facilitates the communications between the importer/exporter and government authorities. i.DISTRIBUTOR - Organization that serves as the authorized agent of the API manufacturer j.DMF - Drug Master File. The main objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy for the manufacture of the API for obtaining an Investigational New Drug Application (IND). k.DOSAGE FORM - Dosage form is a mixture of active pharmaceutical ingredient (API) and non-drug component, i.e., liquid dosage form, solid dosage form and semi-solid dosage form. l.DOUBLE-BLIND STUDY - A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental dosage form and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental dosage form do not affect the outcome. m.ENCAPSULATION - In the manufacture of pharmaceuticals, encapsulation refers to a range of techniques used to enclose medicines in a relatively stable shell known as a capsule. n.EU - European Authorities or the European equivalent of the U.S. Food and Drug Administration (FDA) o.FOOD AND DRUG ADMINISTRATION (FDA) - The U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices. p.FORMULATION DEVELOPMENT - The research process for determining the dosage form ingredients, the amounts of the ingredients and manufacturing processes for adding the ingredients, mixing or blending them together and testing them to assure a tablet or capsule that meets the specifications for the dosage form is manufactured. q.GMPs - Good Manufacturing Practices. GMPs are used by pharmaceutical, medical device, and food manufacturers to produce and test products that people use. In the US, the FDA issues the GMP regulations as the minimum manufacturing requirements. r.IMPORT DUTY - Refers to the tax an importer must pay to the US Government in order to bring foreign products into the commerce of the United States. s.IN VIVO BIOEQUIVALENCE STUDY - Studies conducted in humans to show that two proprietary preparations of a drug would have the same biological effect in humans for all intents and purposes. t.IND - Investigational New Drug. A new drug, antibiotic drug, or biological drug that is used in a clinical investigation. u.LETTER OF AUTHORIZATION - A document required by the Food and Drug Administration that is written by the API manufacturer. In the letter, the API manufacturer grants the FDA the right to review their Drug Master File on behalf of the organization submitting the IND (in this case the Army) to assure the API they manufacture is manufactured and tested following GMPs. It assures that the tests meet the product specifications prior to shipment of the API. The manufacturer must also supply the Army or CSPCRPCC with a signed original copy of the Letter of Authorization so the Army can include a copy with the IND submission. v.PLACEBO - A placebo is a dosage form that does not contain API and thus should not treat or minimize the illness the patient is experiencing. In clinical trials, experimental dosage forms containing API are often compared with placebos to assess the treatment's effectiveness. w.POTENCY - The strength or amount of API in a dosage form. The specifications for the API (Trazodone Hydrochloride, USP) potency of 98.5 to 101.5% are defined in the product specifications. The API must meet the potency specifications through the expiration date. x.SPONSOR - Person who initiates a clinical investigation, but who does not conduct the investigation. y.USP - The United States Pharmacopeia is the official pharmacopeia of the United States. Pharmacopeia meaning literally, 'drug making,' is a reference work for pharmaceutical drug specifications. USP establishes written (documentary) and physical (reference) standards for medicines, food ingredients, dietary supplement products and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency. z.VA - Veterans Affairs PRICE/COST SCHEDULE ITEM DESCRIPTION OFQTYUNITUNITAMOUNT NO. SUPPLIES/SVCS PRICE Base Year (FY 2012) CLIN 0001 40KG ___________________ ____________________ Active Pharmaceutical Ingredient (API), Trazodone Hydrochloride, USP Option Year One (FY 2013) CLIN 1001 40KG___________________ ____________________ Active Pharmaceutical Ingredient (API), Trazodone Hydrochloride, USP Option Year Two (FY 2014) CLIN 2001 40KG___________________ ____________________ Active Pharmaceutical Ingredient (API), Trazodone Hydrochloride, USP ____________________ GRAND TOTAL --- ==================== DELIVERY SCHEDULE SOW Task#Deliverable TitleQty.Delivery 1Base Year (FY12): Purchase of the active pharmaceutical ingredient (API), Trazodone Hydrochloride, USP1 - 40Kg DrumOn or before 07/20/12 2Option Year One (FY13): Purchase of the active pharmaceutical ingredient (API), Trazodone Hydrochloride, USP1 - 40Kg DrumOn or before 09/30/13 3Option Year Two (FY14): Purchase of the active pharmaceutical ingredient (API), Trazodone Hydrochloride, USP 1 - 40Kg DrumOn or before 09/30/14 DELIVERY LOCATON: VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 2401 Centre Avenue, SE ATTN: Jan Hickey c/o CSP Warehouse (151-I) Albuquerque, NM 87106-4180 DELIVERY HOURS: The CSPCRPCC accepts deliveries Monday through Friday (excluding federal holidays) between the hours of 7:30 a.m. and 3:30 p.m. (MST). The provision at 52.212-1, Instructions to Offerors - Commercial Items (Feb 2012), applies to this acquisition. The following provisions are incorporated into 52.212-1 as an addendum to this solicitation: All questions must be in writing & emailed to carlos.jaquez@va.gov. All questions must be received. The Government reserves the right to not answer questions not meeting this timeline if doing so would result in an amendment requiring an extension of the solicitation and to extend would not be in the best interest of the Government. File #1 and File #2 must be submitted electronically to carlos.jaquez@va.gov. Submittal Instructions: Submit the following in three separate files. 1.File #1: Schedule.doc a.Cover letter titled "Schedule RFQ VA258-12-Q-0466" b.Complete Attachment A Contract Administration Data. c.Complete Attachment B Price/Cost & Delivery Schedule. 2.File #2: Technical_Proposal.doc a.Cover letter titled "Technical Proposal RFQ VA258-12-Q-0466" b.The Technical Proposal document should follow the sequential order identified in "FAR 52.212-2 Evaluation-Commercial Items". c.Each item in the Technical Proposal document must be clearly identified by its corresponding number and description. d.NO PRICE INFORMATION SHALL BE INCLUDED IN THE TECHNICAL PROPOSAL (File #2). The provision at 52.212-2, Evaluation - Commercial Items (Jan 1999), applies to this acquisition. (a) The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: This is a best value acquisition utilizing Lowest Price, Technically Acceptable. Award will be made to proposal with lowest price that has been deemed technically acceptable. 1.Price - Provide prices on all line items listed on the schedule. If the lowest price proposal is evaluated as being reasonable and realistic, and is evaluated to be technically acceptable, that proposal represents the best value for the Government. 2.Technical Acceptability - To be technical acceptable Offeror must meet all the technical requirements in the Statement of Work. The technical proposal is to include the following. (All the following items SHALL be addressed in the proposal or it will be considered "non-responsive" and will NOT be considered for award) a.The manufacturer (or the U.S. distributor acting on behalf of the manufacturer) must have a Drug Master File (DMF) for the Trazodone Hydrochloride, USP on file at the Food and Drug Administration (FDA). "The manufacturer (or the U.S. distributor acting on behalf of the manufacturer) must agree to provide a Letter of Authorization to the FDA, allowing the FDA to refer to all pages of the DMF applicable to the manufacture of the Trazodone Hydrochloride, USP to support the Investigational New Drug (IND) application for the P313 clinical research trial. "The manufacturer (or the U.S. distributor acting on behalf of the manufacturer) must agree to provide an original signed copy of the Letter of Authorization to the VA Cooperative Studies Program Clinical Research Coordinating Center (VA CSPCRPCC) or the Army for inclusion in our IND submission to the FDA. b.The Trazodone Hydrochloride, USP manufacturer (or U.S. distributor acting on behalf of the manufacturer) must provide a Certificate of Analysis showing that each lot of API Trazodone Hydrochloride purchased meets the USP specifications. c.The VA CSPCRPCC Laboratory will perform analytical testing to verify the API meets at least the identification and potency specifications prior to final acceptance of the API. d.The manufacturer (or the U.S. distributor acting on behalf of the manufacturer) of the Trazodone Hydrochloride, USP must provide documentation that either the FDA or the European Union Authorities (EU) conducted a recent, successful FDA or EU inspection of the facility in which the Trazodone Hydrochloride, USP is manufactured, preferably for the manufacturing process used to manufacture the Trazodone Hydrochloride, USP. e.The Trazodone Hydrochloride, USP must have a minimum expiration date of 55 months remaining upon receipt at the VA CSPCRPCC. f.The manufacturer (or their US distributor/agent) must handle all interactions with US Customs for exporting the API product from the country of origin and importing it to the US. g.The manufacturer (or their US distributor/agent) must include all Customs Broker, US Customs and shipping/delivery fees in the price of the API (Trazodone Hydrochloride, USP) product. h.The manufacturer (or their US distributor/agent) must handle all interactions with Export and/or Import Brokers for the export of the product from the country of origin and for import into the US. i.The manufacturer (or their US distributor/agent) must include all Export and/or Import Broker fees in the price of the API (Trazodone Hydrochloride, USP) product. j.The manufacturer (or their US distributor/agent) must include all shipping and delivery fees from the manufacturer to delivery at the CSPCRPCC in the price of the API (Trazodone Hydrochloride, USP). (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful Offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of Provision) EVALUATION PROCESS Evaluation Process: All quotes will be evaluated based on their technical acceptability. The award decision will be based on the lowest priced, technically acceptable quote. To be considered technically acceptable, the Offeror shall submit a quote on the brand name or equal requested. Award will be on an "all or none" basis; the Offeror shall submit prices on all CLINs. (a)The following ratings will be used in evaluation Offerors proposal: Acceptable - To receive this rating, the Offeror shall present a proposal that clearly and comprehensively addresses the technical acceptability factor. The Offeror shall provide sufficient details for the Government to determine that the items offered satisfactorily meet the minimum requirements of the solicitation. The proposal shall clearly demonstrate that the Offeror fully understands and is capable of performing the requirement for the total proposed price indicated in its proposal. Unacceptable - An unacceptable rating will be assessed on any Offeror that presents a proposal that demonstrates any of the following: (1) fails to clearly and comprehensively address each of the factors. (2) Fails to provide sufficient detail for the Government to determine whether the proposal satisfactorily meets the minimum requirements of this solicitation in addressing the factors. (3) Fails to clearly demonstrate that the Offeror fully understands and is technically capable to perform the requirements at its total proposed price. Award will be made using the lowest-price, technically-acceptable source selection process. Award will be made to the Offeror that presents the proposal that possesses all of the following characteristics: (1) meets the acceptability standards for non-price factors, (2) Conforms to the solicitation, (3) determined acceptable to the Government, (4) Is from a responsible (as defined in Federal Acquisition Regulation Part 9) Offeror, and (5) Has the lowest price of those Offerors meeting the first four characteristics listed here. Offerors are to include a completed copy of 52.212-3, Offeror Representations and Certificates - Commercial Items (Apr 2012). The clause at 52.212-4, Contract Terms and Conditions - Commercial Items (Feb 20120 applies to this acquisition. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Apr 2012). 1.52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)) 2.Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104 (g)) 3.52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553) 4.52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Pub. L. 108-77, 108-78) 5.52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (FEB 2012) (Pub. L. 109-282) (31 U.S.C. 6101 note) 6.52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (JAN 2011) (if the Offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a) 7.52.219-28, Post Award Small Business Program Rerepresentation (APR 2009) (15 U.S.C 632(a)(2)) 8.52.222-3, Convict Labor (June 2003) (E.O. 11755) 9.52.222-19, Child Labor--Cooperation with Authorities and Remedies (MAR 2012) (E.O. 13126) 10.52.222-21, Prohibition of Segregated Facilities (Feb 1999) 11.52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246) 12.52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793) 13.52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) 14.52.225-1, Buy American Act--Supplies (FEB 2009) (41 U.S.C. 10a-10d) 15.52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury) 16.52.232-34, Payment by Electronic Funds Transfer--Other than Central Contractor Registration (May 1999) (31 U.S.C. 3332) The following clauses and provisions apply to this acquisition: 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) 52.216-18 ORDERING (OCT 1995) 52.216-20 DEFINITE QUANTITY (OCT 1995) 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008) VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (DEC 2009) VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009) VAAR 852.246-71 INSPECTION (JAN 2008) VAAR 852.273-76 ELECTRONIC INVOICE SUBMISSION (Interim - October 2008) 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (JAN 2008) VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008) VAAR 852.273-74 AWARD WITHOUT EXCHANGES (JAN 2003) Offerors are to submit all documents electronically to carlos.jaquez@va.gov by June 6th, 2012 3:00 PM EDT.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VAEPHCC756/VAEPHCC756/VA25812Q0466/listing.html)
Document(s): Attachment; File Name: VA258-12-Q-0466 VA258-12-Q-0466.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=350692&FileName=VA258-12-Q-0466-000.docx); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=350692&FileName=VA258-12-Q-0466-000.docx; File Name: VA258-12-Q-0466 S02 ATTACHMENT A CONTRACT ADMINISTRATION DATA.DOCX (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=350693&FileName=VA258-12-Q-0466-001.DOCX); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=350693&FileName=VA258-12-Q-0466-001.DOCX; File Name: VA258-12-Q-0466 S02 ATTACHMENT B PRICE-COST _ DELIVERY SCHEDULE.DOCX (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=350694&FileName=VA258-12-Q-0466-002.DOCX); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=350694&FileName=VA258-12-Q-0466-002.DOCX; File Name: VA258-12-Q-0466 S02 ATTACHMENT C TECHNICAL ACCEPTABILITY AND PRICE.DOCX (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=350695&FileName=VA258-12-Q-0466-003.DOCX); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=350695&FileName=VA258-12-Q-0466-003.DOCX; File Name: VA258-12-Q-0466 S02 ATTACHMENT D QUALITY ASSURANCE SURVEILLANCE PLAN.DOCX (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=350696&FileName=VA258-12-Q-0466-004.DOCX); Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=350696&FileName=VA258-12-Q-0466-004.DOCX; 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: Department of Veterans Affairs;VA Cooperative Studies Program;Jan Hickey c/o CSP Warehouse (151-I;2401 Centre Avenue, SE;Albuquerque, NM; Zip Code: 87106-4180
Record: SN02760003-W 20120531/120529234945-ea33c236e3208ddea8f5ae7b9a2e4964 (fbodaily.com)
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68 -- API Trazodone Hydrochloride USP - Attachment