MODIFICATION
66 -- COMBINED SYNOPSIS/SOLICITATION FOR AUTOMATED WIRELESS LABORATORY EQUIPMENT AND ENVIRONMENTAL (TEMPERATURE AND HUMIDITY) MONITORING SYSTEM FOR FDA - Amendment 1
- Notice Date
- 8/12/2014
- Notice Type
- Modification/Amendment
- NAICS
- 334516
— Analytical Laboratory Instrument 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
- 14_SOL_1134549
- Point of Contact
- Shaukat Mirza, Phone: 3018277166
- E-Mail Address
-
Shaukat.Mirza@fda.hhs.gov
(Shaukat.Mirza@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Amendment#2 PART 1 - Intro The United States Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA)'s Southeast Regional Laboratory (SRL) has a requirement (BRAND NAME OR EQUAL, FAR 52.211-6 August 1999) to purchase an AUTOMATED WIRELESS LABORATORY EQUIPMENT AND ENVIRONMENTAL (TEMPERATURE AND HUMIDITY) MONITORING SYSTEM. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, (STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS) as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. This solicitation is issued as a Request for Quote (RFQ), using the Simplified Acquisitions Procedures of FAR 13. The solicitations document/incorporated provisions and clauses are those in effect through the current Federal Acquisition Circular: FAC 2005-74. Proposal Due Date: All proposals shall be submitted via email Shaukat.Mirza@fda.hhs.gov by 10:00 AM EASTERN TIME on 13 August 2014. Please see the attached combined synopsis/solicitation. Added: <input type="hidden" name="dnf_class_values[procurement_notice][description][1][added_on]" value="2014-08-06 09:51:52">Aug 06, 2014 9:51 am Modified: <input type="hidden" name="dnf_class_values[procurement_notice][description][1][modified_on]" value="2014-08-12 15:45:41">Aug 12, 2014 3:45 pm Track Changes Amendment#2 The purpose of this amendment is to extend the closing time until 10:00AM tomorrow, 13 Aug 2014 and make correction to the section 10.2: Evaluation Award Criteria (of the attached combined synopsis/solicitation): Award will be made to the vendor whose quote is LOWEST PRICED TECHNICALY ACCEPTABLE (a quote is acceptable if it is for the brand name items specified in the quantitites requested or for an overall technical solution that satisfies all salient functional characteristics specified) and the proposed system has to be approved by FDA IT MASTER APPROVED TECHNOLOGIES (MAT) or IT INVESTMENT MANAGEMENT (ITIM) list approved for FDA ORA by 01 Sept 2014. Amendment#1 The purpose of this amendment is to extend the closing time until COB on Thursday 07 Aug 14 and provide responses to the questions that were received. Please see the questions and responses below; QUESTION # 1) On page 4 of the bid it states that the system must be approved by FDA IT Master Approved Technologies (MAT) or IT Investment Management (ITIM) list. Do you have the specs on what specifically these departments require, outside of just a 900 MHz Wireless Technology? Like for instance, will they accept a better more stable & advanced technology such as 2.4 GHz (802.15.4) Direct Sequence Spread Spectrum (DSSS) with ZigBee Protocol? ANSWER: FDA IT Master Approved Technologies (MAT) or IT Investment Management (ITIM) list is an FDA end user request to FDA IT for approval for use of a vendor provided solution. To bring this request forward, the end user will need the following: For network / server IT solutions a "target state diagram" is required. The diagram should include server (note virtual or physical, hardware and software installation requirements, indicate vendor or customer supplied), client workstation (client app, web browser, etc.; version number, install requirements), vendor solution diagram including wireless routers, access points, transmitter, etc. Vendor supplied documentation must include: background of wireless standards used, required communications dependencies, security protocols, required ports, etc. used and required for full functioning system. Additional information may be requested. QUESTION # 2) The bid calls out for full system functionality by conducting IQ/OQ validation. Are you looking for onsite calibrations for the system and sensors, or do you require just the certificate of calibration from the factory? ANSWER: • IQ would be installation qualification. This would be full documentation that the vendor provided solution is installed and meets all of the vendors defined requirements for installation and is fully functioning. • OQ would be operational qualification. This would be full documentation that the individual input (temperature or humidity) calibrations are fully traceable to the NIST standard and performed by an ISO 17025 accredited calibration laboratory/company. This can be performed onsite or at the factory but must be performed by an ISO 17025 accredited calibration laboratory/company. If calibration is performed at the factory, OQ should include verification of individual input readings with NIST traceable thermometer by an ISO 17025 accredited laboratory. (This may be a new requirement, but calibrations should be good for 11 - 12 months from install/IQ/OQ) • Additionally IQ/OQ would fully demonstrate alarm notification and all other FDA requirements stated in the requisition package.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/14_SOL_1134549/listing.html)
- Place of Performance
- Address: US FDA, Southeast Regional Laboratory, 60 Eighth ST NE, Atlanta, GA 30309, Atlanta, Georgia, 30309, United States
- Zip Code: 30309
- Zip Code: 30309
- Record
- SN03461565-W 20140814/140813022119-fbbed6247f1e46c9409221403fa55001 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |