Inactive

Synopsis for Axumin Obtainment: This is a Sole Source Synopsis published for informational purposes only. This proposed action is for the procurement of Axumin (fluciclovine F 18) injections for the p... Synopsis for Axumin Obtainment: This is a Sole Source Synopsis published for informational purposes only. This proposed action is for the procurement of Axumin (fluciclovine F 18) injections for the patient population served by the Medical Treatment Facility (MTF) on Wright-Patterson Air Force Base (WPAFB). See Attachment 1, Statement of Work (SOW). The Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b)(1), “Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available.” The contracting officer has determined that only one source is reasonably available: PETNET Solutions, Inc. This proposed procurement will be a Sole Source under North American Industry Classification System Code (NAICS) 325412: Pharmaceutical Preparation Manufacturing. Business size standard for NAICS 325412 is 1,250 employees. PSC/FSC code: 6515: Medical and Surgical Instruments, Equipment, and Supplies. The proposed source is PETNET Solutions, Inc. located at 810 Innovation Dr., Knoxville, TN 37932-2562. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. This notice of intent is not a request for competitive quotations. However, all responsible sources may submit a capability statement, proposal, quotation or exception to the intent to purchase on a sole source basis, which shall be considered by the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to comply with FAR 5.207(c)(15), the reason for lack of competition is as follows: The Government requires Axumin (fluciclovine F 18) injections for the patient population served by the Medical Treatment Facility (MTF) on Wright-Patterson Air Force Base (WPAFB). The Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in patients with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It greatly reduces the number of studies needed for prostate cancer diagnosis and can detect prostate cancer at an earlier stage. The sole distribution of the injection that meets these needs is through PETNET Solutions, Inc. The proposed sole source is the only known reliable source able to satisfy the Government’s requirements. Please see Attachment 1, Statement of Work (SOW) for more complete details. Delivery Schedule: Vendor will deliver doses of Axumin to the Customer Locations FOB destination and will add any applicable delivery charges to the invoice. Delivery schedules will be determined at time of order. Delivery Destination: 4881 Sugar Maple Drive Bldg. 830. Area A WPAFB OH 45433-5529 Delivery Type: FOB Destination (As defined in FAR 2.101 – Definitions, the seller or consignor is responsible for risk of loss.) Inspection and Acceptance: Both inspection and acceptance will be by the Government at Destination. Important Notice to Contractors: All prospective awardees are required to register at the System for Award Management (SAM) and to maintain active registration during the life of the contract. SAM can be accessed at https://www.sam.gov. For a detailed description of the applicable SAM requirements and payment information, please review the clauses included in the attached solicitation. Any information should be e-mailed to both kyle.wheat@us.af.mil, and jenah.hernek@us.af.mil. Only inquiries/information received through e-mail by this date will be considered. Be advised all correspondence sent via e-mail shall contain a subject line that reads “Axumin Injections” Note that e-mail filters at Wright-Patterson AFB are designed to filter e-mails without subject lines or with suspicious subject lines or contents (i.e., .exe, or .zip files). Therefore, if this subject line is not included, the e-mail may not get through the e-mail filters. Also be advised that .zip or .exe files are not allowable attachments and may be deleted by the e-mail filters at Wright-Patterson Air Force Base. If sending attachments with e-mail ensure only .PDF, .doc, or .xls documents are sent. The e-mail filter may delete any other form of attachments. Attachments: Statement of Work (SOW), dated 4 February 2020 PETNET Sole Source Justification (SSJ)

Inactive

AXUMIN INJECTIONS The Government is conducting market research and identifying, as potential sources, companies that may possess the expertise, capabilities, and experience to meet the requirements as... AXUMIN INJECTIONS The Government is conducting market research and identifying, as potential sources, companies that may possess the expertise, capabilities, and experience to meet the requirements as specified in the Program Description below. CAUTION: This Sources Sought is issued solely for information and planning purposes. In accordance with Part 10 of the Federal Acquisition Regulation, the U.S. Government is conducting market research. The intended purpose is to identify potential sources that may possess the expertise, capabilities, and experience to meet 88 SGC/SGCS requirement. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. Furthermore, 88 SGC/SGCS is not at this time seeking proposals, and will not accept unsolicited proposals. Responders are advised that the Government will not pay for any information or administrative costs incurred in response to this sources sought. Please be advised that all submissions become Government property and will not be returned. All costs associated with responding to this sources sought will be solely at the responding party’s expense. Not responding to this sources sought does not preclude participation in any future RFP, if any is issued. In accordance with Federal Acquisition Regulation 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is the responsibility of the interested parties to monitor this beta.SAM website for additional information pertaining to this source sought. INSTRUCTIONS: Below is a document containing a description of the requirement and a Contractor Capability Survey, which allows you to provide your company’s capabilities. If, after reviewing these documents, you desire to participate in the market research, you should provide documentation that supports your company’s capability in meeting these requirements. Failure to provide documentation may result in the government being unable to adequately assess your capabilities. If you lack sufficient experience in a particular area, please provide details explaining how you would overcome the lack of experience/capabilities in order to perform that portion of the requirement (i.e., teaming, subcontracting, etc.). Both large and small businesses are encouraged to participate in this Market Research. Joint ventures or teaming arrangements are encouraged. Questions relative to this market survey should be addressed via email to Jenah Hernek (AFLCMC/PZIBA), jenah.hernek@us.af.mil no later than 6:00 pm EST on 10 February 2020. Verbal questions will NOT be accepted. PROGRAM DESCRIPTION Axumin (Flucicovine F 18) injections are required for patients that have suspected recurrent prostate cancer. Axumin is a molecular imaging agent indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer. REQUIREMENTS PLEASE SEE ATTACHED STATEMENT OF WORK FOR MORE DETAILS. WARRANTY In the event that the customer is unable to perform a patient scan due to an Axumin dose arriving in an unusable form, the vendor will not invoice customer for the dose or associated additional charges. CONTRACTOR CAPABILITY SURVEY Part I. Business Information Please provide the following business information for your company/institution and for any teaming or joint venture partners: Company/Institute Name: Address: Point of Contact: CAGE Code: Phone Number: E-mail Address: Web Page URL: Size of business pursuant to North American Industry Classification System (NAICS) Code: 325412: Pharmaceutical Preparation Manufacturing Based on the above NAICS Code, state whether your company is: Small Business, (Self-Certified or Third Party Certified) (Yes / No) Small Disadvantaged Business, (Self -Certified or Third Party Certified) (Yes / No) Woman Owned Small Business, (Self -Certified or Third Party Certified) (Yes / No) Economically Disadvantaged Woman Owned Small Business, (Self -Certified or Third Party Certified) (Yes / No) 8(a) Certified, (Self -Certified or Third Party Certified) (Yes / No) HUBZone Certified, (Self -Certified or Third Party Certified) (Yes / No) Veteran Owned Small Business, (Self -Certified or Third Party Certified) (Yes / No) Service Disabled Veteran Small Business, (Self -Certified or Third Party Certified) (Yes / No) *All interested contractors must be registered in SAM in order to be eligible for award of Government contracts. The government reserves the right to consider a small business set-aside based upon responses hereto for any subsequent action. A statement as to whether your company is domestically or foreign owned (if foreign, please indicate the country of ownership). Please provide a statement that the respondent will allow or will not allow the Government to release proprietary data. Please provide a statement to acceptability of the following proposed non-commercial provisions and clauses, as they are determined to be consistent with customary commercial practice. FAR 52.204-7, System for Award Management FAR 52.204-13, System for Award Management Maintenance FAR 52.204-16, Commercial and Government Entity Code Reporting FAR 52.204-18, Commercial and Government Entity Code Maintenance FAR 52.217-8, Option to Extend Services FAR 52.217-9, Option to Extend the Term of the Contract FAR 52.232-39, Unenforceability of Unauthorized Obligations FAR 52.252-1, Solicitation Provisions Incorporated by Reference FAR 52.252-2, Clauses Incorporated by Reference FAR 52.252-5, Authorized Deviations in Provisions FAR 52.252-6, Authorized Deviations in Provisions in Clauses DFARS 252.203-7002, Requirement to Inform Employees of Whistleblower Rights DFARS 252.204-7003, Control of Government Personnel Work Product DFARS 252-225-7048, Export-Controlled Items DFARS 252-243-7001, Pricing of Contract Modifications AFFARS 5352.201-9101, Ombudsman AFFARS 5352.223-9000, Elimination of Use of Class I Ozone Depleting Substances (ODS) AFFARS 5352.223-9001, Health and Safety on Government Installations AFFARS 5352.242-9000, Contractor Access to Air Force Installations ATTENTION small business respondents who are interested in submitting a proposal as the prime contractor for this effort: No set aside decision has been made; however, the Air Force is contemplating setting this acquisition aside for Small Businesses if there is sufficient demonstrated interest and capability. Note that a key factor in determining an acquisition to be a Small Business Set Aside is that two or more small business prime contractors must be capable of performing at least 50% of the entire scope of the effort, as defined in Federal Acquisition Regulation (FAR) clause 52.219-14, Limitations on Subcontracting. The clause reads, in part, as follows: “Limitations on Subcontracting (Nov 2011) … (c) By submission of an offer and execution of a contract, the Offeror/Contractor agrees that in performance of the contract in the case of a contract for – (1) Services (except construction). At least 50 percent of the cost of contract Performance incurred for personnel shall be expended for employees of the concern… ”. Provide specific details and rationale as to how compliance with FAR clause 52.219-14 would be achieved, including specific details regarding teaming arrangements, etc. If subcontracts are to be used, provide anticipated percentage of effort to be subcontracted and whether small or large businesses will be used. Teaming and/or subcontracting arrangements should be clearly delineated and previous experience in teaming must be provided. ATTENTION all potential respondents: The acquisition strategy for this program has not been finalized. If this acquisition is not set aside for small business, it is anticipated that the contract may contain a small business utilization requirement. Please provide feedback on the requirement and what areas are likely candidates for SB subcontracting. Part II. Capability Survey Questions Is your firm registered in the System for Award Management (SAM)? In accordance with federal regulations, all contractors doing business with the federal government must be registered in the SAM database. Describe briefly the capabilities of the nature of the services you provide. Describe your company's past experience on previous, similar services. Include contract numbers, a brief description of the work performed, period of performance, agency/organization supported, and individual point of contact (Contracting Officer or Program Manager). Are there specific requirements in the documentation that we provide that would currently preclude your product/service from being a viable solution to our requirement? Are there established market prices for our requirement? If you offer this product and/or service to both U.S. Government and commercial sources, is the same workforce used for both the U.S. Government and general public? Is our requirement offered to both under similar terms and conditions? Briefly describe any differences. If your company is interested, submit your responses to jenah.hernek@us.af.mil. E-mail responses should be received no later than 6:00 pm EST on 10 February 2020. All responses must be UNCLASSIFIED; no classified material will be accepted or considered with this Sources Sought Synopsis. The response to Part I. Business Information should be single spaced, 12pt font. The response to Part II. Capabilities should be limited to no more than 10 pages (8.5x11 inches), single spaced, 12pt font. In addition, identify a representative to support further Government inquiries and requests for clarification of the information provided, if needed. Respondents should indicate which portions of their response are proprietary and should mark them accordingly. The Air Force will handle proprietary items in accordance with FAR 2.101 and 3.104. Responses to questions from interested parties will be promptly answered via email. If deemed appropriate, non-proprietary questions may be posted on this beta.SAM website.