Sources Sought Notice: X-Ray Diffraction (XRD) Instruments

Sources Sought Notice: X-Ray Diffraction (XRD) Instruments MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is conducting market research to support the Center for Drug Evaluation and Research (CDER) Part of the mission statement of Food and Drug Administration (FDA) Division of Pharmaceutical Analysis (DPA) is to help ensure the safety and efficacy of human drugs used in the United States and to provide a strong analytical science base to support complex FDA investigations and enforcement actions concerning the quality and authenticity of human drugs. X-ray diffraction (XRD) is a powerful and well-established technique for analyzing materials. Office of Testing and Research (OTR)/DPA is in need to acquire a benchtop X-ray diffractometer and an advanced floorstanding X-ray diffraction system to perform pharmaceutical testing (basic identification and fast screening) and research (qualification and quantification of polymorphic impurities), respectively. The XRD instruments will be used to characterize opioid drug products and other pharmaceuticals to support FDA's mission. This is a Sources Sought notice to determine the availability of Small Businesses capable of supplying the required supply item/services. This notice is for planning purposes only, and does not constitute an invitation for Bids, Request for Proposal or Request for Quotation or an indication the Government will award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. Capabilities Required: Capable sources shall be required to furnish an XRD system to perform testing and research on characterizing opioid drug products and other products and other pharmaceuticals. The system shall be required to meet or exceed the following minimum salient characteristics: I. Performance Requirements The benchtop and floorstanding XRD instruments shall have the following salient characteristics: 1. Shall be manufactured by a same vendor. 2. Shall include personal computer (PC) package or integrated PC suitable for operating each XRD instrument. 3. Shall include designated commercial off the shelf (COTS) software for instrument control and data analysis. 4. Shall include the International Center for Diffraction Data(ICDD)'s Powder Diffraction File (PDF) 4+ full file site license. 5. Shall include shipping, handling, installation, installation qualification (IQ) and operational qualification (OQ) of each instrument. 6. Shall provide instrument familiarization and training to 2 end users. 7. Shall provide 12 months warranty to start at the date of IQ/OQ completion. The benchtop XRD instrument shall meet the following salient characteristics: 1. Shall be a complete X-ray diffractometer with internal cooling system and no water supply needed. It shall be on-site ready, mobile for on-location operation, and no installation and alignment required. 2. The X-ray generator shall be standard sealed copper (Cu) tube or equivalent and be able to generate at least 30 kV / 7.5 mA radiation. 3. The XRD detector shall be a 1D detector with at least 150 channels and allow high-quality diffraction data acquisition at least 100 times faster than a conventional point detector system. 4. Shall use vertical goniometer with sample mounted in horizontally. The goniometer range shall cover at least -3 to ~ 140 2Theta. 5. Shall include sample spinner with a range of 1 rpm to 80 rpm or wider. 6. Shall include a rotating sample stage with at least 6-position sample changer. 7. The exterior dimension shall be smaller than 30" x 30" x 30" (h x d x w). 8. Shall include standard sample holders, zero-background sample holders, filters, slits, and other necessary accessories. The advanced floorstanding XRD system shall meet the following salient characteristics: 1. Shall be a complete X-ray diffractometer with a radiation enclosure and an external cooling-water recirculating system. 2. The X-ray generator shall be standard sealed Cu tube or equivalent, with maximum continuous power of 1.8 kW or higher, and be able to generate at least 40 kV / 40 mA radiation. 3. The XRD detector shall be a 0D/1D/2D multi-mode detector or equivalent. 4. Shall use vertical goniometer with sample mounted in horizontally. The measuring range must cover at least -10 to ~ 160 2Theta. 5. Shall include sample spinner with a range of 1 rpm to 80 rpm or wider. 6. Shall include a rotating sample stage with at least 6-position sample changer. 7. Shall include CRYO and humidity chamber sampling unit. 8. Shall include capillary attachment. 9. Shall include Small Angle X-ray Scattering (SAXS) attachment. 10. Shall include standard sample holders, zero-background sample holders, air sensitive dome sample holder, filters, slits, and other necessary accessories. Capability Statements: Responses to this sources sought shall unequivocally demonstrate the respondent's capabilities to provide the instrument, accessories, and services described above. Though the target audience is small business, all interested parties may respond. At a minimum, responses shall include the following: 1. Business name and bio, DUNS number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm. 2. Past Performance information shall include date of services, description, dollar value, client name, 3. Client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of company (to include DUNS number and size status) if not the respondent. 4. Descriptive literature, brochures, marketing material, etc. detailing the nature of services the responding firm is regularly engaged in providing. 5. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and Schedule Item Numbers (SIN)s that are applicable to this potential requirement are also requested. If a large business, clarify if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response. Response Instructions: Interested parties shall respond with capability statements in person, by e-mail, fax, mail or other delivery method before 3:00 PM Eastern Time on June 6th, 2019 to Christopher.mcgucken@fda.hhs.gov. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre?solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non?proprietary technical information in any resultant solicitation(s).