SOLICITATION NOTICE
88 -- Eight (8) Non-Human Primates (NHP) - Female Rhesus Monkeys
- Notice Date
- 2/21/2013
- 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
- 13-223-SOL-00038
- Archive Date
- 3/16/2013
- Point of Contact
- James Scott Rawls, Phone: 8705437540
- E-Mail Address
-
james.rawls@fda.hhs.gov
(james.rawls@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 announcement constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. This solicitation is being issued in conjunction with FAR Part 13 Simplified Acquisition Procedures, as applicable. The solicitation number is 13-223-SOL-00038. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses in effect through the Federal Acquisition Circular 2005-65, dated January 29, 2013. The associated North American Industry Classification System (NAICS) Code is 112990 - All Other Animal Production; Small Business Size Standard is $.75 million. This RFQ is Non-Human Primates (NHP) - Female Rhesus Monkeys. The FDA intends to issue a firm fixed-price purchase order for NHPs that meet the following specifications described below. SUPPLIES OR SERVICES AND PRICES/COSTS CLIN, Item Description, Qty, U/I, Unit Price, Extended Price 0001, Indian origin, drug naïve, female Rhesus monkeys, 2 to 3 years old. 8 Each, Unit Price: ______, Extended Price: _______ 0002, Crates, 8 Each, Unit Price: ______, Extended Price: ______ 0003, Shipping, 1 Job, Unit Price: ______, Extended Price: ______ TOTAL: ______ BACKGROUND AND OBJECTIVES: Objective: It is believed that the NHP is closest to humans in predicting the human response to drugs. The goal of this study is to determine the effect of pregnancy on the disposition of drugs (Tamiflu, oseltamivir phosphate [OP]) in the nonhuman primate model. In this phase, non-pregnant females (non-pregnant controls) will be exposed to OP by IV injection and at a different date, by oral dosing. This information will be used to develop a protocol to measure the distribution of OP in pregnant monkeys at different stages of pregnancy. Requirement: The contractor shall provide and deliver eight (8) Indian origin, drug naïve, female Rhesus monkeys, 2 to 3 years old and shall meet the specifications as follows: 1. All monkeys shall test negative for the following pathogens before shipping: • Tuberculosis (a negative TB shall be confirmed just prior to shipping) • Cercopithecine herpes virus 1 (B virus) • SRV/D (Simian Retrovirus type D) • SIV (Simian Immunodeficiency Virus) • STLV-1 (Simian T-Lymphotropic Virus-1) 2. All monkeys shall have either (1) been vaccinated against measles as a juvenile or (2) be vaccinated against measles prior to shipping. 3. All monkeys shall be examined by a licensed veterinarian, Doctor of Veterinary Medicine (DVM) as defined by the Animal Welfare Act Regulations (9 CFR, Subchapter A, Part 1 - Definition of Terms), experienced in NHP medicine and surgery, and found to be in good health prior to shipping. 4. Health records and documentation of testing/treatment for all monkeys shall be provided to the NCTR Attending DVM before shipping. 5. Monkeys shall be tested for Shigella, Salmonella, Campylobacter, Yersinia, and helminth & pathogenic protozoal parasites. Treatment regimens for any monkeys testing positive for these organisms shall be discussed with the Contracting Officer, Contracting Officer's Representative (COR), and the NCTR Principal Investigator (PI) before initiation of treatment. 6. The monkeys shall be of Indian origin, drug naïve (with the exception of anesthesia), and of the prescribed age range and sex (two-to-three year old, nulliparous, female Rhesus macaque (Macacca mulatta) monkeys). 7. All eight (8) animals shall be delivered in the same shipment. 8. Shippers shall comply with Animal Welfare Act Regulations regarding the transportation standards for NHP, Title 9, Subchapter A, Part 3 -- Transportation Standards. 9. The contractor shall be responsible for meeting all requirements associated with shipment and delivery of animals. 10. The contractor shall maintain liaison with carrier personnel in order to assure the animals receive proper care in accordance with USDA standards and guidelines during transit. 11. The contractor shall start the process to ship and deliver the NHPs 30 days from date of award. All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor Name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. Shippers must comply with Animal Welfare Act Regulations regarding the transportation standards for NHP, Title 9, Subchapter A, Part 3 -- Transportation Standards. The contractor shall be responsible for meeting all requirements associated with shipment and delivery of animals. The contractor shall submit to the COR by phone the proposed shipment schedule and method of transport no less than 72 hours prior to shipment. Animals shall be delivered in properly ventilated escape-proof crates furnished by the contractor(s). Each animal shall be situated in a separate compartment for delivery purposes. Only clean uncontaminated crates shall be used in transporting the animals. Each crate shall be marked with the delivery address, purchase request number, contract number, and animal identification. FOB Point: Food and Drug Administration, National Center for Toxicological Research, 3900 NCTR Road, Jefferson, AR 72079 (Point of contact, building, and room number will be provided at time of award). Period of Performance: 30 calendar days after time of award. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (FEB 2012), applies to this acquisition. The following addenda have been attached to the clause. The following FAR and HHSAR clauses, incorporated by reference, apply to this acquisition. Clauses and provisions can be obtained at https://www.acquisition.gov/far/ 52.204-7 Central Contractor Registration. (DEC 2012) 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 (JAN 2010) 352.223-70 Safety and Health (JAN 2006) 352.231-71 Pricing of Adjustments (JAN 2001) 352.242-71 Tobacco-Free Facilities (JAN 2006) The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the 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: Food and Drug Administration Jefferson Laboratories Complex Attn: James "Scott" Rawls 3900 NCTR Road Building 50, Room 432 Jefferson, AR 72079 or via email: james.rawls@fda.hhs.gov One copy to the COR or other program center/office designee clearly marked "courtesy copy only:" (To be provided at time of award). Deliveries and/or work 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 Birthday of Martin Luther King, Jr. Washington's Birthday Memorial Day Independence Day Labor Day Columbus Day Veteran's Day Thanksgiving Day Christmas Day Deliveries and/or work shall be Monday through Friday, 7:30 AM - 5:30 PM, excluding Federal Holidays or Closures. The Contractor shall provide the FDA Delivery Location Point of Contact with at least three (3) days written notice prior to delivery and/or work. 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. nctrinvoices@fda.hhs.gov. 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: 52.204-10, 52.209-6, 52.209-10, 52.219-4; 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 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. 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: (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Lowest Price Technically Acceptable. 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. If the Government determines technical proposals to be essentially equal, the price factor becomes increasingly important and may become the determining factor. 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 requirements identified above. The offeror shall specifically address each technical requirement stated above, which demonstrate that the offeror meets the technical requirements. 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. Prices must be inclusive of all service charges, fees, etc., but should not include taxes. 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 (DEC 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 an offer, which if timely received, shall be considered. The offer must reference solicitation number 13-223-SOL-00038. The offers are due in person, by postal mail, or email to the point of contact listed below on or before March 1, 2013 by 1300 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, OA/OAGS/DAP, 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: james.rawls@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/13-223-SOL-00038/listing.html)
- Place of Performance
- Address: Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), 3900 NCTR Rd., Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN02992621-W 20130223/130221234418-97f4c6bf222aaf62791f75f0f73a6d7b (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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