SOURCES SOUGHT
66 -- Particle Sizer - FDA-SS-1179571
- Notice Date
- 2/27/2017
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-RFQ-1179571
- Archive Date
- 3/24/2017
- Point of Contact
- Lisa K. Yaw, Phone: 2404024018
- E-Mail Address
-
lisa.yaw@fda.hhs.gov
(lisa.yaw@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Sources Sought Notice NOTE: This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses, HUBZone small businesses, service-disabled, veteran-owned small businesses, 8(a) small businesses, veteran-owned small businesses, woman-owned small businesses, or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition, which is 334516, Analytical Laboratory Instrument Manufacturing. The associated small business standard is 1,000 employees. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. 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 it submits. 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. 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). Background The Office of Biotechnology Products (OBP) regulates therapeutic proteins which have the potential to form aggregates under certain conditions. These aggregates can negatively impact product quality and safety. Additionally, contaminants such as silicone oil introduced during the manufacturing process are a concern and need to be monitored to assure product quality and safety. A particles sizer instrument is required to assist OBP in fulfilling its mission. Scope The instrument must be capable of simultaneously counting and measuring protein aggregates and silicone oil particles in a single sample utilizing the technique of Resonant Mass Measurement (RMM). Instrument Requirements • Have a minimum sample volume less than or equal to 100uL • Possess a lower limit of detection at least (better than) 500 attograms • Operate at a sample loading pressure of 8-34psi • Have a resolution greater than +/- 25nm at 1μm using polystyrene beads in water • Measure particles in the range of 50nm - 5μm • Capable of distinguishing protein aggregates by measuring negative buoyancy • Occupy a countertop footprint less than 30x30x20” Additional/Consumable Items • Include a computer monitor/PC and software that operates the instrument • Include a minimum of 15 disposable micro sensors Shipping, Installation, Training, and Support • Crating and shipping shall be included to the delivery address • On site installation, hardware, software, and applications training shall be provided at the FDA site. All appropriate training manuals and literature shall be supplied either electronically or in hard copy • Technical support shall be provided through common avenues: phone, web, fax, during standard business hours Optional Service/Maintenance Agreement The FDA shall have a unilateral right to exercise optional periods to continue the maintenance work described below. Maintenance and service shall include: • Software updates during the service agreement period • Technical phone support and onsite visits for diagnosis of problem and repairs inclusive of all parts, labor, and travel expenses • Service rendered under agreement shall be completed within 5 business days of request by Government, unless otherwise authorized. CAPABILITY STATEMENT/INFORMATION SOUGHT The FDA is requesting interested, qualified small businesses to provide a capability statement showing their ability and willingness to complete this requirement. The capability statement will be sent electronically to Lisa Yaw at Lisa.Yaw@fda.hhs.gov in a commonly used format, such as Microsoft Word or pdf. This capability statement will be no more than five pages, excluding a cover page and table of contents, and will include examples of successfully completing relevant similar work, including a description of the similar work and client contact information. The FDA will be determining capability based on the ability to perform the tasks delineated above. Interested eligible small businesses will also include company information to determine eligibility, including their contact information, Dun and Bradstreet (DUNS) number and size and business type (e.g. 8(a), HUBZone, etc.,) based on the applicable NAICS code for the proposed acquisition 334516, Analytical Laboratory Instrument Manufacturing. The associated small business standard is 1,000 employees. Entities have until 2 pm ET, Thursday, March 9, 2017 to respond to the FDA.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-RFQ-1179571/listing.html)
- Place of Performance
- Address: Food and Drug Administration, White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, United States
- Record
- SN04415357-W 20170301/170227234313-5182badddf38fcfab246e95d85ae0dd3 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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