Sources_Sought_FDA-1194511_NIR_Spectrometer.docx

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA) is conducting market research to support the Center for Drug Evaluation and Research (CDER)’s requirement for a one (1) near infrared spectrometer, one (1) internal multiplexer to allow multi-probes to be connected to the spectrometer, one (1) external measurement channels for measurement of standards, one (1) NIR sensor for non-contact measurements, one (1) data collection system, and (1) data collection, and analysis software package.

The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer for the items described herein. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The associated North American Industry Classification System (NAICS) Code is-334516 – Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 1,000 employees.

Background:

Emerging manufacturing technologies that have the capability to increase the assurance of product quality increasing take advantage of advanced sensor-based analytics. The FDA will use this equipment to obtain scientific knowledge in support of developing quality standards for blend and content uniformity for generic solid oral products, especially with low drug load or poor flow properties. Therefore, the FDA requires one online NIR system consisting of the components mentioned above for the measurement of quality attributes in solids processing with specifications outlined below.

Specifications:

Near Infrared Spectrometer System

· The system shall allow computer controlled measurements.

· The system shall have a rugged design with low maintenance required.

· The system shall provide accurate in-line measurements in less than 5 seconds.

· Shall offer built-in multiplexer options that allow control of no less than 6 sensor heads with fiber optic cables by the single spectrometer.

· The system shall allow measurements of both using the internal light source and an external light source. The light path can be switched between difference sources.

· The detector of the spectrometer shall be thermoelectrically cooled and temperature-controlled.

· The system shall provide contactless measurement of moving solid materials including powders and granules in diffuse reflection mode.

· The sensor head non-contact analysis shall connect with the spectrometer using fiber optic cable.

· The fiber optic cable shall allow extended distance of no less than 5m.

· For non-contact analysis, the working distance shall be no less than 100 mm.

· For non-contact analysis, the diameter of the measurement area shall be no less than 10 mm.

· For non-contact analysis, a reference standard shall be integrated within the probe for automatic background measurements.

· Shall provide capability to prevent fouling of the measurement window.

· Shall provide mounting hardware for in-line measurement with minimal dead space.

· The in-line mounting hardware shall use appropriate materials such as stainless steel and Polyoxymethylene, sapphire window with thickness of no less than 6mm.

· Shall provide laboratory mount for off-line calibration measurements.

· The probe head should provide flexible connection to keep measurement area clean from dust and dirt.

Data systems

· The data system shall be integrated within the spectrometer system, for the acquisition, processing, evaluation, and reporting measurement data both in laboratory and process environment.

· The spectroscopy software shall have configurable use interface.

· The spectroscopy software shall allow export of spectral data and evaluation results to other programs, for example Excel, Unscrambler, etc.

· The spectroscopy software shall execute common spectroscopic analysis and evaluation functions.

· The spectroscopy software shall support the validation of the spectrometer, including operational and performance qualification.

· The software shall provide package to offer quantitative analysis for multivariate analysis models.

· The software shall be able to offer an automatic routine for the optimization of calibration methods.

· The software shall allow storing and managing data in a database.

· The data system shall allow communication with process control systems.

Installation, Training and Additional System Requirements:

The Contractor shall provide inside delivery, installation and training of FDA scientists on the system operation.

Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s) to include on-site training. Warranty service shall include trouble-shooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of 1-year.

FOB Point Destination. All items shall include shipping, handling and inside delivery to the destination identified herein. Delivery/installation completed within sixteen (16) weeks after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA’s White Oak Campus facility located at 10903 New Hampshire Ave, WO BLDG 62 Loading Dock, Silver Spring, MD 20993.

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:

· Business name, 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 if responding to provide a product manufactured by another firm);

· Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.

· Three (3) years of past performance information for the manufacture, installation and/or sale and warranty support in which the offeror has provided same or substantially similar system solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of 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 the manufacturer (to include DUNS number and size status) if not the respondent.

· If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.

· Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.

· If a large business, identify the subcontracting opportunities that would exist for small business concerns;

· Standard commercial warranty and payment terms; and

· Though this is not a request for quote, informational pricing is encouraged.

The government is not responsible for locating or securing any information not identified in the response.

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements on or before July 6, 2017 by 15:00 hours (Central Time in Jefferson, Arkansas). Reference FDA-1194511.

Notice of Intent Responses to this Sources Sought announcement will assist the Government in determining whether or not any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole-source acquisition procedures.

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 FedBizOpps. 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).