MODIFICATION
66 -- Lyophilizer - Responses to Questions
- Notice Date
- 6/26/2013
- 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
- FDA-13-223-SOL-00065
- Archive Date
- 7/23/2013
- Point of Contact
- Sondea R Blair, Phone: 8705437469
- E-Mail Address
-
sondea.blair@fda.hhs.gov
(sondea.blair@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Q&A This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6 as applicable and in conjunction with FAR part 13.3 and 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. The solicitation number is FDA-13-223-SOL-00065. 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) 2005-66, 01 April 2013. The associated North American Industry Classification System (NAICS) Code is- 334516 Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. This acquisition is set-aside 100% for small business concerns. The US Food and Drug Administration's (FDA) Division of Biological Standards and Quality Control (DBSQC) within the Center for Biologic Research and Evaluation (CBER) requires a Lyophilizer with post warranty service/maintenance. Background: CBER's Division of Biological Standards and Quality Control (DBSQC) is working to enhance production of reference standards and testing reagents (i.e., reference materials) to increase capability of supplying influenza reference materials for mitigating the consequences of pandemic influenza. To accomplish the mission, DBSQC must be prepared to respond to a greater-than-normal demand for CBER reference materials thereby, being able to produce and distribute effective influenza vaccine products in response to an increased public health need. In order to increase the manufacturing of influenza vaccine reference standards, DBSQC requires a Lyophilizer with post warranty preventive maintenance service. Minimum Requirements: -Shall have a minimum of six usable shelves providing capacity of approximately 15000 3 mL vials and 7500 5 mL vials -Shall be a benchmark design -Shall include a butterfly isolation valve -Shall have a hydraulic stoppering system -Shall include at least eight thermocouples -Shall include a minimum of one condenser temperature probe -Shall include a minimum of one shelf temperature probe -Shall have a barometric end point process control software to perform pressure rise test for product dryness -Shall include a validation document package -Shall include a removable bottom tray -Shall include a minimum -Shall provide automated system control -Shall include automated leak rate testing -Shall include Manometer -Shall include a vacuum sensor -Shall include a computer workstation with Windows operating system (minimum XP Pro with Microsoft Office) Equipment measurements shall comply with filling suite measurements in the Government's facilities due to structural space constraints and shall adhere to the following: a. The back of the lyophilizer shall not extend beyond the outside clean-room wall more than 6' 5" to 9'4" (depending on the lyophilizer location); thus, providing enough space to cart supplies between the back of the machine and the wall. b. See attachment 1 for depiction of structural space and please note that all measurements listed between the hatch marks are in millimeters (note: 1 mm = 0.0393700787 of an inch) and door 5296B appears to be about 1,080 mm wide. Based on this hallway width requirement and the measurements between the two walls (i.e., 707 + 2347 - 310 = 2744 mm); the lyophilizer should not stick out beyond the clean room wall more than 1,664 mm, which is 5.459 feet (2744 - 1080 = 1664 mm; 1664 x 0.0393700787 = 65.51 inches / 12 = 5.459 feet). The 310 mm subtracted from the wall measurement was to account for the half of the support pillar that is encroaching into the 2,347 mm space. Another lyophilizer will be going into this wall and we will need at least 5.5 feet (1676 mm) of the wall width (1300 + 2500 = 3800 mm), so that the new lyophilizer can not be wider than 2124 mm (6.9 feet). Please note: calculations are estimates. A contractor may schedule an appointment to view the installation site by contacting the Contract Specialist identified herein. Other Requirements: Installation and Training -The contractor shall provide inside delivery, installation, and clean-up of the installation site for the entire system with documented Installation/Operational Qualification, validation, and on-site training -Installation shall be inclusive of all labor, parts, installation kits, and travel expense. -Training shall be inclusive of contractor labor, materials, and travel expense. Turn-Key System Offerors are expected to provide a turn-key solution which shall include, but not be limited to: -All hardware, components, interfaces, instrument computers, software, installation and installation engineering support, on-site familiarization and operation training, and Installation Qualification/Operational Qualification (IQ/OQ) required to meet these specifications and the FDA's stated need and intended use for these systems. Warranty -System shall be inclusive of a minimum 12-month warranty inclusive of parts, labor, and travel expense. Qty 1 Each - Total System Price__________________ *Note: Award determination shall be inclusive of option year prices Post Warranty Preventive Maintenance Requirements: Post-Warranty Preventive Maintenance (Option Years 1-4): Shall include (but not be limited to): -Minimum of one scheduled preventive maintenance visit annually inclusive of parts, travel, and labor expense. -Unlimited number of on-site service visits (to include engineering support) inclusive of all parts, labor and travel with maximum 72-hour response -Priority preventive and corrective maintenance performed by OEM-certified technicians, following OEM specifications, manuals, and service bulletins, using OEM-certified tools and replacement parts, components, subassemblies, etc. Post Warranty Period of Performance: Option Period 1: 12-month period to commensurate upon the completion of the base 12-month warranty: Option Period 1 Price:___________ Option Period 2: 12-month period to commensurate upon the completion of the option period 1 preventive maintenance agreement: Option Period 2 Price:___________ Option Period 3: 12-month period to commensurate upon the completion of the option period 2 preventive maintenance agreement: Option Period 3 Price:___________ Option Period 4: 12-month period to commensurate upon the completion of the option period 3 preventive maintenance agreement: Option Period 4 Price:___________ On-site preventative maintenance and recalibration visits shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or WWW.OPM.GOV. Federal holidays are as follows: New Year's Day Martin Luther King, Jr. Washington's Birthday Memorial Day Independence Day Labor Day Columbus Day Veteran's Day Thanksgiving Day Christmas Day FOB Destination: US Food and Drug Administration Center for Biologics Evaluation and Research 10903 New Hampshire Avenue Building 72, Room 5296 Silver Spring, MD 20832 Period of Performance: Delivery, installation, training, and Government acceptance shall occur in December 2013. Solicitation Provisions: Contract Type: Commercial Item-Firm Fixed Price. The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (FEB 2012) applies to this solicitation. The following addenda have been added to this provision: Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2013. System for Award Management Registration In accordance with the with the Debt Collection Improvement Act of 1996, in order to be considered for an award of a Federal contract, the contractor must be registered in the System for Award Management (SAM), a free web site that encompasses the capabilities of the - Central Contractor Registry (CCR); Federal Agency Registration (Fedreg); Online Representations and Certifications Application (ORCA); Excluded Parties List System (EPLS); and the Catalog of Federal Domestic Assistance. If a new Contractor, you will need only your personal information to create an account in SAM. If a Contractor with an active record in CCR, you will not need to establish a SAM account. The CCR record transfers to become the active SAM account. (1) Definitions. "Registered in the SAM database" means that- (i) The Contractor has entered all mandatory information, including the DUNS number or the DUNS+4 number, into the SAM database; (ii) The Contractor's CAGE code is in the SAM database; and (iii) The Government has validated all mandatory data fields, to include validation of the Taxpayer Identification Number (TIN) with the Internal Revenue Service (IRS), and has marked the record "Active". The Contractor will be required to provide consent for TIN Attachment, Page 1 of 4 validation to the Government as a part of the SAM registration process. "System for Award Management (SAM)" means the primary Government repository for prospective federal awardee information and the centralized Government system for certain contracting, grants, and other assistance related processes. It includes- (i) Data collected from prospective federal awardees required for the conduct of business with the Government; (ii) Prospective contractor submitted annual representations and certifications in accordance with FAR Subpart 4.12. [If unable to complete updated representations and certifications in SAM, the Contractor must complete a paper copy of their Representations and Certifications and submit it with their proposal]; and (iii) The list of all parties suspended, proposed for debarment, debarred, declared ineligible, or excluded or disqualified under the nonprocurement common rule by agencies, Government corporations, or by the Government Accountability Office. (2) The Contractor shall be registered in the SAM database prior to submitting an invoice and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation. The SAM registration shall be for the same name and address identified on the contract, with its associated CAGE code and DUNS or DUNS+4. If indicated by the Government during performance, registration in an alternate system may be required in lieu of SAM. If the Contractor does not have a DUNS number, it should contact Dun and Bradstreet directly to obtain one. A contractor may obtain a DUNS number- (i) Via the internet at http://fedgov.dnb.com/webform or if the contractor does not have internet access, it may call Dun and Bradstreet at 1-866-705-5711 if located within the United States; or (ii) If located outside the United States, by contacting the local Dun and Bradstreet office. The contractor should indicate that it is a contractor for a U.S. Government contract when contacting the local Dun and Bradstreet office. (3) The Contractor is responsible for the accuracy and completeness of the data within the SAM database, and for any liability resulting from the Government's reliance on inaccurate or incomplete data. To remain registered in the SAM database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the SAM database to ensure it is current, accurate and complete. Updating information in the SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document. (4) Contractors may obtain information on registration and annual confirmation requirements via the SAM accessed through https://www.acquisition.gov or by calling 866-606-8220, or 334-206-7828 for international calls. If there is any difficulty in updating this record, contact the Federal Service Help Desk at www.fsd.gov or 866-606- 8220 for SAM assistance. https://www.sam.gov/portal/public/SAM/ (End of Clause) Contract Clauses: The clause at 52.212-4, Contract Terms and Conditions - Commercial Items (Feb 2012), applies to this acquisition. The following addenda have been added: The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer's representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. Other Terms and Conditions Maintenance and Repair All maintenance and repair activities (including warranty work) shall be accomplished in accordance with Original Equipment Manufacturer (OEM) specifications. Service Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA COR and Contract Specialist, not later that the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month; negative reports are required. The following clauses and provisions are incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at https://www.acquisition.gov/far. FAR Clause 52.204-4 Printed or Copied Double-Sided on Recycled Paper. (MAY 2011) FAR Clause 52.204-7 Central Contractor Registration. (DEC 2012) FAR Clause 52.217-9 Option to Extend the Term of the Contract (MAR 2000) (a)... within 1 day of contract expiration;.... at least 15 days before the contract expires... (c)...shall not exceed 4 years, exclusive of the requirement under item 1. The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.htm 352.202-1 Definitions JAN 2006 352.203-70 Anti-Lobbying JAN 2006 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations OCT 2009 352.223-70 Safety and Health JAN 2006 352.231-71 Pricing of Adjustments JAN 2001 352.242-71 Tobacco-Free Facilitates JAN 2006 The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) Direct or negotiate any changes in the statement of work; (2) Modify or extend the period of performance; (3) change the delivery schedule; (4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) Otherwise change any terms and conditions of this contract. The Contracting Specialist for this order is: Sondea Blair, Contracting Specialist 3900 NCTR Rd HFT-320, Room 421 Jefferson, AR. 72079 Phone: (870) 543-7469 Email: sondea.blair@fda.hhs.gov The COR is responsible for: (1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) Interpreting the statement of work and any other technical performance requirements; (3) Performing technical evaluation as required; (4) Performing technical inspections and acceptances required by this contract; and (5) Assisting in the resolution of technical problems encountered during performance. The COR for this order is: shall be completed at time of award. Invoice Submission Invoices shall be submitted to the attention of the designated Contract Specialist identified above and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions. I. An original and two (2) copies shall be submitted to: FDA/OC/OA/OFO/OFS Attn: Division of Payment Services 3900 NCTR Road, HFT-324 Building 50, 6th floor, suite 616 Jefferson, AR 72079 Phone: (870) 543-7446 Fax 870-543-7224 An electronic invoice can be emailed to the following address: nctrinvoices@fda.hhs.gov II. One copy to the Contracting Officer Representative (COR) or other program center/office designee, clearly marked as: Courtesy Copy Only: To be completed at time of award. Questions regarding invoice payments should be directed to the FDA payment office at phone or email: 870.543.7446 or nctrinvoices@fda.hhs.gov. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Jan 2013), applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.204-10, 52.209-6, 52.219-6, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-51, 52.225-5, 52.225-13, 52.232-33. Solicitation Provisions: Contract Type: Commercial Item-Firm Fixed Price. The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items applies to this solicitation. Addendum to Paragraph (b)(8) Representations and Certifications- In addition to completing the representations and certifications at FAR 52.212-3(b), the Contractor's quote shall also clearly show that the Contractor has selected the appropriate certification under FAR 52.222-48. Note: This solicitation is being issued under the premise that the Contractor will certify that the combination of equipment/service it will propose to fulfill this requirement is exempt from the Service Contract Act per the conditions set forth in FAR 52.222-48 & FAR 22.1003-4(c). If this is the case and the Contractor certifies that is exempt under the terms and conditions of 52.222-48, then clause 52.222-51 will flow per usual from this solicitation to the resulting order. In the event that a Contractor does not make this certification, traditional Service Contract Act clauses 52.222-41, and 52.222-43 shall be included in the resulting order award as well as Wage Determination WD 05-2103 (Rev.-12): http://www.wdol.gov/wdol/scafiles/archive/sca/94-2103.r12 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 will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: (i) Technical capability of the items/services offered to meet or exceed the Government's requirement (ii) Price Technical Acceptability: Technical acceptability will be determined by review of information submitted by the quoter who must provide sufficient descriptive literature that unequivocally demonstrates that offered services meet the technical requirements as stated herein. Pricing: Offerors shall provide pricing, clearly delineating the applicable performance period, using the attached format for each period of performance. Prices shall be firm-fixed-price and shall not be subject to any further economic price increase beyond the initial price offered. Options: The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). The government is not responsible for locating or securing any information, which is not identified in the proposal however, 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 Government reserves the right to make an award without discussions. 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. Respondents are responsible for delivery in person, by e-mail, fax, mail or other delivery method their complete proposal and any additional documents before 10:00 am (Central Standard Time - Local Prevailing Time in Jefferson, Arkansas) on July 03, 2013 to sondea.blair@fda.hhs.gov, Fax (870) 543-7990, or mail to the U. S. Food and Drug Administration, FDA/OO/OFBA/OAGS/DAP, Attention of Sondea Blair, 3900 NCTR Road, Building 50, Room 421 Jefferson, AR 72079-9502. PLEASE NOTE - The above contact information is for the Contracting Office and not necessarily the delivery address. The delivery address is indicated in the FOB Destination section below. When appropriate, Respondents should consult with delivery providers to determine whether their documents will be delivered prior to the scheduled time. For information regarding this solicitation, please contact Sondea Blair by e-mail at sondea.blair@fda.hhs.gov. Questions regarding this solicitation will be accepted only via email and shall be submitted no later than 10:00 AM CST on June 27, 2013. 6/26/2013 Q&A (see attachment)
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-13-223-SOL-00065/listing.html)
- Place of Performance
- Address: US Food and Drug Administration, Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, Silver Spring, Maryland, 20832, United States
- Zip Code: 20832
- Zip Code: 20832
- Record
- SN03100120-W 20130628/130626234950-b40b926b05049f6090a8ec6c3c2dff4d (fbodaily.com)
- Source
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FedBizOpps Link to This Notice
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