SOURCES SOUGHT
J -- Installation Qualification/Operation Qualification Services
- Notice Date
- 4/28/2015
- Notice Type
- Sources Sought
- NAICS
- 811219
— Other Electronic and Precision Equipment Repair and Maintenance
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 3900 NCTR Road, HFT-320, Bldg 50 | Rm 421, Jefferson, Arkansas, 72079, United States
- ZIP Code
- 72079
- Solicitation Number
- FDA1147923
- Archive Date
- 5/22/2015
- Point of Contact
- Regina R. Williams, Phone: (870) 543-7012
- E-Mail Address
-
regina.williams@fda.hhs.gov
(regina.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 Biological Research (CBER) requirement for Installation Qualification/Operation Qualification (IQ/OQ) services in support of three SP Scientific Virtis brand Lyophilizers. This is a Sources Sought Notice 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. This notice is for planning purposes only, and does not constitute an Invitation for Bids, Request for Proposals or Request for Quotation, or an indication the Government will contract for the items contained herein. This notice is not to be construed as a commitment on the part of the Government to 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. The associated North American Industry Classification System (NAICS) Code is- 811219 - Other Electronic and Precision Equipment and Repair and Maintenance, with a small business size standard of $20.5 million. Statement of Work (SOW) Background/Scope The Division of Biological Standards and Quality Control (DBSQC) serves as a Standard Preparation and Testing laboratory for CBER regulated products. One of the responsibilities of the DBSQC is to ensure high quality of vaccines coming to the United States (US) market. This goal is achieved by a well planned testing scheme for safety and efficacy of vaccine lots before they reach consumers. DBSQC also maintains a well-equipped Standards preparation capacity to prepare standards for potency testing and share them with manufacturers and other regulatory agencies. Standards play a critical role in maintaining testing validity for tests conducted before and after the products are licensed. An important part of the laboratory activities involve testing influenza vaccines for potency and identity. This requires preparation of reference standard for the industry. DBSQC currently owns the following three (3) Virtis Lyophilizers: Model -Ultra 35 Super XL- Serial Number 219568 Model- Genesis 25 Super XL- Serial Number 219406 Model- Genesis 25 XL-Serial Number 219777 The 3 lyophilizers are critical for drying the standards after being filled in vials for distribution. This requirement is for the IQ/OQ for the 3 lyophilizers identified above. The qualification of the equipment is required in accordance with Current Good manufacturing Practices (cGMP), International Organization for Standardization (ISO), and DBSQC Standard Operating Procedures (SOPs). Technical Requirement At a minimum, the Contractor shall provide the following: 1. Validation guide and workbook for the above Pilot Freeze Dryers IQ/OQ validation protocols that are designed to provide an acceptable degree of confidence that the purchased equipment meets the functional and design specifications as expressed by the original equipment manufacturer (OEM). All activities shall be developed to follow a sequential progression as items are reviewed and tested. The validation package shall include life cycle documentation and calibration certificates. 2. IQ/OQ Validation services IQ/OQ validation services at the customer's location. Services shall include labor of a technician to complete the standard tests, as well as provide objective evidence prior to shipment and installation for each entry including signing off by individuals completing each form. 3. Service Records and Reports The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Contracting Officer 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. Period of Performance Thirty (30) calendar days after contract award. Place of Performance White Oak Campus Federal Research Center Building 52/72 10903 New Hampshire Avenue Silver Spring, MD 20933 The respondent to this source sough shall furnish sufficient technical information necessary for the Government to conclusively determine its capability to provide products/services and components meeting the technical requirements identified above. 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 meet or exceed above specifications. 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 and/or sale of same or substantially similar items to include 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. The government is not responsible for locating or securing any information, not identified in the response. Interested parties shall respond with capability statements which are due in person, by postal mail or email to the point of contact listed below on or before May 7, 2015 by 12:00 PM (Central Time in Jefferson, Arkansas) at the FDA/OO/OFBA/OAGS/DAP, Field Operations Branch, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email regina.williams@fda.hhs.gov. Reference FDA1147923. 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)."
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- Record
- SN03712532-W 20150430/150428234745-29c648dd2a36d339348c033e4cfc2013 (fbodaily.com)
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