G
The solicitation document and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-68, dated June 26, 2013.
The associated North American Industry Classification System (NAICS) Code is- 541380 - Testing Labs; Small Business Size Standard is $14.0 in millions of dollars.
The RFQ is for services related to the delivery of monoclonal antibodies. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below.
SUPPLIES OR SERVICES AND PRICES/COSTS
CLIN Item Description Qty U/I Unit Price Extended Price
0001 A minimum of 40 positive supernatants against each of the following antigens: Can F1, Can F3, and Mus M1.
Isotyped clones:
• Minimum of 10 against Can F1 (at least 2 frozen vials of each type)
• Minimum of 10 against Can F3 (at least 2 frozen vials of each type)
• Minimum of 10 against M1 (at least 2 frozen vials of each type) 1 Job
TOTAL
Background:
This requirement is in support of the US FDA, Center for Biologics Evaluation and Research (CBER), Laboratory of Immunobiochemistry (LIB), and the overall objective is to obtain monoclonal antibodies of different isotypes against three (3) allergenic proteins: Can F1, Can F3, and Mus M1.
For standardization and for accurate potency measurements, it's imperative to know the amount of major allergens present in allergenic extracts. LIB's goal under this requirement is to develop a sandwich ELISA assay for measurement of these reported major allergens in dog and mouse allergen extract from various manufacturers.
To this end, we need a capable contractor to deliver high affinity hybridoma clones of different isotypes against these allergenic proteins. The contractor shall have trained staff to perform the immunization, fusion, and further screening of hybridoma clones. The contractor shall also respond to all our queries in a timely manner and be able to complete the project successfully in a timely manner.
Technical Requirements:
• Contractor shall be experienced in generating custom monoclonal antibodies.
• Pure Proteins will be provided by LIB/CBER to contractor within 15 working days after contract award for immunization and screening purposes.
• Hybridoma supernatants shall be screened by ELISA assay using positive
Screening.
• Contractor shall provide CBER/LIB with maximum positive hybridoma supernatants for screening. The Contractor shall provide at a minimum 40 positive supernatants against each antigen for in house screening and provide at least 10 working days to complete this screening.
• Contractor shall be able to provide 500 uL - 1.0 mL supernatants to CBER/LIB for preliminary in house screening for selection of high affinity binders in ELISA assay.
• Contractor shall provide 10 clones to the customer. Each clone shall be delivered in 2 to 3 separate frozen vials.
• Contractor shall determine isotypes of these deliverable clones.
• Project shall be completed in a timely manner (desired completion date is within eight (8) weeks of contract award--not to exceed 10 weeks) and contractor shall provide one (1) interim project report at the midpoint of the performance period to CBER/LIB.
• Items must be delivered under stable conditions.
Government-Furnished Materials (GFM):
The Government will provide Pure Proteins to the successful offeror's facility within 15 working days after contract award.
Place of Performance:
The analysis effort shall take place at the successful offeror's off-site location (TBD). However, as specified in the above Technical Requirements section, the supernatants and clones shall be shipped to: HHS/FDA/CBER/LIB, 29 Lincoln Dr., Bldg. 29, Rm. 214, Bethesda, MD 20892.
Period of Performance:
Estimated to be eight (8) to 10 weeks after contract award.
The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (JUN 2012), applies to this acquisition. The following addenda have been attached to the clause.
The following FAR and HHSAR clauses, incorporated by reference, and apply to this acquisition. Clauses and provisions can be obtained at https://acquisition.gov/far/index.html.
52.204-4 Printed or Copied Double-Sided on Recycled Paper (MAY 2011)
52.204-7 Central Contractor Registration. (DEC 2012)
FAR 52.232-18 Availability of Funds (Apr 1984)
FAR 52.232-99, Providing Accelerated Payment to Small Business Subcontractors (Deviation) (AUG 2012)
The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.htm
352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations (JAN 2010)
352.223-70 Safety and Health (Jan 2006)
352.231-71 Pricing of Adjustments (JAN 2001)
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.
The COR name will be provided at time of award.
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 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 contract; (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.
Invoice Submission
The contractor shall submit one (1) original copy of the invoice to the address specified below:
FDA/OC/OA/OFO/OFS
Attn: Division of Payment Services
3900 NCTR Road, HFT-324
Building 50, 6th Floor, Suite 616
Jefferson, AR 72079
An electronic invoice can be emailed to the following address:
[email protected].
One copy to the Contracting Officer Representative (COR) or other program center/office designee clearly marked "courtesy copy only: (To be provided at time of award).
Questions relating to when payment will be received should be directed to the FDA payment office at the email below or at (870) 543-7446 or (870) 543-7042. [email protected].
The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items (Jan 2013) applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: (b) 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.223-18, 52.225-3, 52.225-13, and 52.232-33.
The provision at FAR 52.212-1 Instructions to Offerors - Commercial Items (FEB 2012) applies to this solicitation.
Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2013.
The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (a) 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 is significantly more important when compared to price in determining the best value to the government.
Technical capability will be determined by review of information submitted by the offeror which must provide sufficient technical information necessary for the Government to conclusively determine that the offered products and/or services meets the technical requirement identified above. Offerors may provide technical specifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror.
The price proposed shall be detailed and represent the offeror's response to the schedule of supplies/services above.
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. Include the firms DUNS number with quote.
A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.
The government reserves the right to make an award without discussions.
The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (APR 2012), 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 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 a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-13-223-1118904. The quotes are due in person, by postal mail or email to the point of contact listed below on or before July 15, 2013, by 1600 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, OA/OAGS/DAP, Attn: James "Scott" Rawls, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502.
For information regarding this solicitation, please contact James "Scott" Rawls at (870) 543-7540, fax (870) 543-7990 or email: [email protected].