SOLICITATION NOTICE
66 -- Partical Counting Microscope to be used for Characterizing Particles in Pharmaceutical Products
- Notice Date
- 9/10/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 333314
— Optical Instrument and Lens Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- 09-223-SOL-00251Synopsis-Solicitation
- Archive Date
- 9/30/2009
- Point of Contact
- Aaron A. Glazier, Phone: 8705437577
- E-Mail Address
-
aaron.glazier@fda.hhs.gov
(aaron.glazier@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) 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. This requirement is being issued in conjunction with FAR 13.5 Test Program for Certain Commercial Items, as applicable. The solicitation number is 09-223-SOL-00251. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-35. The associated North American Industry Classification System (NAICS) Code is-333314-Optical Instrument and Lens ManufacturingSoftware Publishers; Small Business Size Standard 500 employees. The Health and Human Services Department-Food and Drug Administration is seeking to find a microscope that meets the following specifications and service requirements: I. Performance Specifications 1. Must detect particles in liquids from 0.75 to 400 micrometers at a minimum concentration of at least 5 particles per milliliter and a maximum concentration of 800,000 particles per mL for 2.5 micrometers. Sizing accuracy must conform to NIST sizing standards. 2. Field of view must be at least 1.7 by 1.4 millimeters. 3. Sample introduction must accommodate small sample size (samples as small as 0.5 milliliters). Sample introduction must be made through automated flow or single use sampling with ability to stir the sample. Sample introduction must be done with a minimum of agitation and shear. 4. Analysis rate must be at least 200 microliters per minute. 5. Particle morphological parameters to include size, area, perimeter, aspect ratio, feret diameter, circularity and transparency. 6. Software must include real time display of suspended particles, histograms, trend charts, scatterplots, morphological parameter filtering and sub-population isolation, image labeling, cropping and storage capabilities, data and image formats compatible with Microsoft Office products. 7. Must be able to provide a bid that includes the following consumables: at least two NIST traceable standards to calibrate the size of the instrument, one standard to calibrate concentration and four flow through cells. II. Trade and Service Specifications 8.The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. The life cycle of this instrument is intended to be greater than ten years at full performance. CDER must be able to expect routine customer service and technical support from the vendor during its lifecycle. 9.The entire system must be warranted for parts and labor for 12 months from the date of installation. The vendor shall provide information as to whether or not an extended warranty or follow-on service contracts are available. The vendor must also be capable of servicing the instrument through the extended warranty or service contract. This requirement does not obligate CDER to purchase an extended warranty. Contract Type: Commercial Item-Firm Fixed Price. Simplified acquisition procedures will be utilized. FOB Point destination. To be delivered no later than 30 days after contract award. Product will be shipped to: c/o Tedera Miliken DDA RM1002 HFD-920 1114 Market St, Rm 1002 Saint Louis, MO 63101 Payment terms net 30 days. Standard commercial warranty is required if applicable. The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation is the lowest priced while still meeting the aforementioned specifications. Technical acceptability will be determined by review of information submitted by the offeror which must provide a description in sufficient detail to show that the product offered meets the government’s requirement. The Government will evaluate the technical capability factor as to whether the offer meets or exceeds the minimum specifications. The government reserves the right to make an award without discussions. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the product and/or service meets the technical requirements. The offer shall include any applicable technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror. The Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items, applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition. The following addenda have been attached to the clause. The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer’s representative (COTR) specified at award. If the supplies or services are acceptable, the COTR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COTR shall document the nonconforming items/services and immediately notify the contracting officer. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.203-6 alt I, 52.219-4, 52.219-8, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-39, 52.225-5, 52.225-13, and 52.232-33. The following additional provisions and/or clauses apply: 52.204-4 & 52.204-7. Clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.arnet.gov/far/ The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.htm 352.270–10 Anti-lobbying. (January 2006) One or more of the items under this acquisition is subject to the World Trade Organization Government Procurement Agreement and Free Trade Agreements. 352.270-19 Electronic Information and Technology Accessibility (January 2006) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by Public Law 105–220 under Title IV (Rehabilitation Act Amendments of 1998) and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that all EIT acquired must ensure that: (1) Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities; and (2) Members of the public with disabilities seeking information or services from an agency have access to and use of information and data that is comparable to the access to and use of information and data by members of the public who are not individuals with disabilities. This requirement includes the development, procurement, maintenance, and/or use of EIT products/services; therefore, any proposal submitted in response to this solicitation must demonstrate compliance with the established EIT Accessibility Standards. Information about Section 508 is available at http://www.section508.gov/ The following applications standards have been identified as being applicable for this service: 1194.21 Software applications and operating systems 1194.31 Functional performance criteria 1194.41 Information, Documentation and Support CCR Requirement - Company must be registered in the Central Contractor Registration (CCR) system before an award could be made to them. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit an offer, which if timely received, shall be considered. The offer must reference solicitation number 09-223-SOL-00251. The offers are due in person, by postal mail, fax or email to the point of contact listed below on or before 15 September, 2009 by 16:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, OC/OSS/OAGS, Attn: Aaron A. Glazier, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. Preferred method of proposal delivery is via email at aaron.glazier@fda.hhs.gov For information regarding this solicitation, please contact Aaron A. Glazier at (870) 543-7577, or email aaron.glazier@fda.hhs.gov
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/09-223-SOL-00251Synopsis-Solicitation/listing.html)
- Place of Performance
- Address: Missouri, United States
- Record
- SN01950095-W 20090912/090911001824-b59ffa8f0e843ab126ba432fb3952386 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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