SOLICITATION NOTICE
88 -- FTepiSTAT3-/- Mice
- Notice Date
- 4/8/2014
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 112990
— All Other Animal Production
- 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-14-233-1132219
- Archive Date
- 4/30/2014
- Point of Contact
- Howard Nesmith, Phone: 870-543-7459
- E-Mail Address
-
howard.nesmith@fda.hhs.gov
(howard.nesmith@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration intends to award a Purchase Order on a sole source basis to The Jackson Laboratory (referred to hereafter as Jackson Laboratory), 600 Main St, Bar Harbor, ME 04609, for the items listed below. This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This requirement is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures. This announcement constitutes the only solicitation; no request for quote (RFQ) is available and a written solicitation will not be issued. Notwithstanding, any firm that believes it is capable of providing the required items as stated herein may submit a capability statement to document its ability to provide the required item(s). A determination to compete this procurement based on a response to this notice is solely within the discretion of the government. The solicitation number is FDA-14-233-1132219. Per FAR 6.302-1, the Government is permitted to conduct sole source acquisitions in cases where the supplies or services required by the agency are available from only one responsible source. The Government has determined that Jackson Laboratory, 600 Main St., Bar Harbor, ME 04609, (DUNS 042140483) is the only vendor who can provide the required FTepiSTAT3-/- Mice. To further aid in an existing study, the Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), Division of Veterinary Services (DVS) requires the development and delivery of 50 FTepiSTAT3-/- mice which are not currently in existence. Generating this new strain (FTepiSTAT3-/-), shall require genetically defined mice carrying an inducible, keratinocyte-specific deletion of the STAT3 gene (epiSTAT3-/-) combined with mice having a constitutive deletion in the filaggrin deficient "flaky tail" (FT) gene. The mice are required for research focused on eczema vaccinatum, a poorly understood, severe complication of smallpox vaccination. The current goals are (a) to develop and characterize a novel model of eczema vaccinatum; (b) to evaluate potency of vaccinia immune globulin (VIG), the only approved therapeutic for eczema vaccinatum. This data could suggest that while STAT3 contributes to antiviral functioning in keratinocytes, additional factors in the skin may play a role in the EV phenotype. One such factor may be filaggrin. Filaggrin mutations in people are associated with chronic skin disease (ichthyosis, atopic dermatitis) and increased susceptibility to skin infection, and are ineligible for smallpox vaccination. Due to the relocation of DVS, its current animal housingand vivarium have been temporarily terminated, therefore the Jackson Laboratory is currently the only entity maintaining the STAT3 (base model) mice (which were generated for the FDA under a previous contract) and the filaggrin deficient "flaky tail" (FT) mice required to generate the requested FTepiSTAT3-/- mice. During relocation and to prevent delay in the current study it is necessary for Jackson Laboratory to generate the FTepiSTAT3-/- mice using the STAT 3 mice currently being maintained for the FDA and deliver to the DVS when the relocation is complete. Jackson Laboratory having developed the parent (base) STAT 3 model and establishing the genetic gene line would preclude any other research animal supplier from providing FTepiSTAT3-/- mice. If another supplier were to develop the new strain, introducing them into the current study would result in compromising the study efforts by introducing a different set of genetic parental genes. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-72 January 30, 2014. The associated North American Industry Classification System (NAICS) Code is- 112990- All Other Animal Production; tiny_mce_marker.75 Small Business Size standards in millions of dollars. The Food and Drug Administration intends to solicit and negotiate with only one source under the authority of FAR 6.302-1 for the following: Scheduled items include: • 50 ea - FTepiSTAT3-/- Mice 5-6 Weeks of Age To be delivered in 5 shipments of 10 mice each delivered between approximately October 2015 and April 2016. Contract Type: Commercial Item-Firm Fixed Price. Simplified acquisition procedures will be utilized. FOB Point Destination: FDA/CBER/VMS, 10903 New Hampshire Ave., Silver Spring, MD 20993. The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None 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: (i) Technical capability of the item offered to meet the Government requirement. (ii) Price. The Government will award a contract to the lowest price technically acceptable quote. Technical acceptability will be determined by review of information submitted by the offeror which must provide a description in sufficient detail to show that the product offered meets the Government's requirement. The government is not responsible for locating or securing any information, which is not identified in the proposal. To ensure information is available, vendors must furnish as part of their proposal all descriptive material necessary for the government to determine whether the product meets the technical requirements. Offerors shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offerors equipment. If the vendor proposes to modify a product so as to make it conform to the requirement of this solicitation the vendor shall include a clear description of such proposed modifications and clearly mark any descriptive materials to show modifications. The government reserves the right to make an award without discussions. Contract clauses- The clause at FAR 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to the clause: The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer / 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 contractor shall submit one (1) original copy of each 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 Fax 870-543-7224 An electronic invoice can be emailed to the following addresses: nctrinvoices@fda.hhs.gov Questions relating to when payment will be received should be directed to the fda payment office at (870) 543-7446 or (870) 543-7042. An electronic invoice can be emailed to the following addresses: traci.jones@fda.hhs.gov and gaylen.wilson@fda.hhs.gov. Invoices submitted under this contract must comply with the requirements set forth in far clauses 52.232-25 (prompt payment) and 52.232-33 (payment by electronic funds transfer - central contractor registration) and/or other applicable far clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (i) name and address of the contractor; (ii) invoice date and invoice number; (iii) purchase order/award number; (iv) description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including: (a) period of performance for which costs are claimed; (b) itemized travel costs, including origin and destination; and (c) any other supporting information necessary to clarify questionable expenditures; (v) shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading; (vi) terms of any discount for prompt payment offered; (vii) name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (viii) name, title, and phone number of person to notify in event of defective invoice; (ix) taxpayer identification number (tin); (x) electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (xi) name and telephone number of the fda contracting officer technical representative (COTR) or other program center/office point of contact, as referenced on the purchase order; and (xii) any other information or documentation required by the purchase order/award. An electronic invoice is acceptable if submitted in adobe acrobat (pdf) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing. The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at http://www.acquisition.gov/far/ FAR Clause 52.204-4 Printed or Copied Double-Sided on Recycled Paper FAR Clause 52.204-7 Central Contractor Registration FAR Clause 52.232-40 Providing Accelerated Payment to Small Business Subcontractors 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 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 Officer for this order is: to be completed at time of award. Phone: xxxx Email: xxxx 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: to be completed at time of award. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.204-10, 52.209-6, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.223-18, 52.225-3 Alt I, 52.225-13, and 52.232-33. If the Offeror fails to furnish required laboratory animal representations, Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) Certification, and the ability to provide certification as to the overall health of sentinel animals for the past 2 years, or reject the terms and conditions of the solicitation, may be excluded from consideration. Offerors may submit a capability statement to document its ability to provide the required items, which will be considered if received on or before April 15, 2014 by 1:00 PM (Central Standard Time in Jefferson, Arkansas). The statements must reference solicitation number FDA-14-233-1132219. The Offers are due in person, by postal mail, fax or email at the Food and Drug Administration, NCTR/OSS/OFFAS, HFT-320, 3900 NCTR Road, Jefferson, AR 72079-9502. For information regarding this solicitation, please contact Howard Nesmith at (870) 543-7459, FAX (870) 543-7990 or email howard.nesmith@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-14-233-1132219/listing.html)
- Place of Performance
- Address: FDA/CBER/VMS, 10903 New Hampshire Ave., Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN03332809-W 20140410/140409021845-353b7d3cfdcf37518f2c7671dba881af (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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