Q--Pharmaceutical Compounding Services (Must be Drug Quality Safety Act & 503a Compliant)

THIS IS A SOURCES SOUGHT NOTICE, ALONG WITH A REQUEST FOR QUOTATIONS. THE INFORMATION BEING REQUESTED WILL BE USED FOR PLANNING PURPURSE ONLY. QUOTATIONS ARE BEING REQUESTED TO DETERMINE IF THE REQUIREMENT CAN BE PURCHASED AT A FAIR AND REASONABLE PRICE AND TO DETERMINE IF THE REQUIREMENT CAN BE PURCHASED UNDER FAR PART 8 (REQUIRED SOURCES) OR FAR PART 13 (OPEN MARKET SOURCES). ALL INTERESTED SOURCES THAT ARE COMPLIANT WITH THE DRUG QUALITY AND SECURITY ACT AND THE COMPOUNDING QUALITY ACT ARE ALLOWED TO RESPOND. ALL QUOTATIONS SHALL PROVIDE CERTIFICATION OF SUCH COMPLIANCE. This notice does not constitute the final solicitation and is not to be construed as a commitment by the Government. Once all quotations have been received, a final solicitation that will be result in an award will be posted on one or all of the following: NASA SEWP, FBO.gov and GSA E-buy or if applicable, oral solicitation procedures will be used. As stipulated in FAR 15.201, responses to this notice are not considered offers and cannot be accepted by the Government to form a binding contract. No solicitation exists that will result in an award at this time. The decision to solicit for a contract shall be solely within the Department of Veteran s Affairs discretion. Any information submitted by respondents to this Sources Sought Notice is voluntary and the Government will not reimburse any costs associated with the submission of information in response to this notice. Respondents will not be individually notified of any results of the review of the information received. The Department of Veterans Affairs, Northern California Healthcare System; Mather, CA 95655 anticipates a requirement for Pharmaceutical Compounding Services. The North American Industry Classification Systems (NAICS) Code proposed is Q031. The NAICS code is 446110. The Purpose of the Requirement: The pharmaceuticals will be used in a randomized, double-blind, placebo-controlled, crossover cognitive neuroscience study. the investigators are evaluating whether the COMT inhibitor tolcapone impacts memory and self-regulation, as measured both behaviorally (via cognitive testing) and neurophysiologically (via functional MRI). The objective of this research project is to evaluate whether the FDA-approved medication tolcapone can improve self-regulation in veterans with a history of mild traumatic brain injury Requirement/Specifications: (See Attached Statement of Work) a. Compounding of 45 tolcapone 200mg/riboflavin 25mg capsules b. Compounding of 45 riboflavin 25mg matching capsules c. Bottling and labeling 2 bottles one for each batch d. Packing and shipping to Northern California Healthcare System, 10535 Hospital Way; Mather, CA 95655 The Government's evaluation of the information received will be used to determine whether any subsequent solicitation for quotes should be issued based on full and open competition, full and open competition excluding sources, as a set-aside for small businesses, or any other particular small business designation (e.g. SDVOSB, HUBZone, 8(a), WOSB, VOSB, etc.). Responses shall be submitted electronically to the following e-mail address: Shannon Reid, contact@example.gov no later than 5 January 2017, 2:00 pm EST. NOTE: RESPONSES TO THIS SOURCES SOUGHT NOTICE SHALL INCLUDE THE FOLLOWING: Note: Subject Line of Email Shall State: Response to Sources Sought for 612-17-1-352-0011 1 Quotation with Name, Address, Point of Contact, Phone, Email Address 2 - Duns & Cage Information, Socio-Economic Group, annual revenue and employee size, any anticipated teaming arrangements, System for Award Management expiration date, Vetbiz.gov registration and expiration date. 3 - Whether or not the company is a supplier or manufacture. 4 Whether or not you the requirement is on your GSA/FSS/NASA SEWP Schedule and its number or state that any quotation you provide will be Open Market. 5 If you will be offering the brand preferred or an equal. State the equal. 6 A description of similar services offered to the Government and to commercial customers. 7 - Any responses involving teaming agreements/subcontractors should delineate between the work that will be accomplished by the prime and the work accomplished by the teaming partners/subcontractors. The Government will use this information in determining its small business set-aside decision. 8 - Status as a Foreign-owned/foreign-controlled firm and any contemplated us of foreign national employees on this effort.