SOLICITATION NOTICE
88 -- Pharmacokinetic Analysis of Toxicants in Non-Human Primates
- Notice Date
- 7/4/2013
- 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
- FDA-13-223-1115874
- Archive Date
- 7/27/2013
- 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; proposals are being requested and a written solicitation will not be issued. This solicitation is being issued in conjunction with FAR Part 13.5--Test Program for Certain Commercial Items. The solicitation number is FDA-13-223-1115874. 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 (FAC) 2005-68, dated June 26, 2013. The associated North American Industry Classification System (NAICS) Code is- 112990 - All Other Animal Production; Small Business Size Standard is $0.75 in millions of dollars. The RFQ is for Pharmacokinetic Analysis of Toxicants in Non-Human Primates - NHP - Rhesus Monkeys of Indian Origin. 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 16 Rhesus Monkeys, Off-site Animal Boarding, Experiment 1 (Parts 1 and 2), and Experiment 2 (Trimesters 1 to 3) 1 Job TOTAL DELIVERY/PAYMENT SCHEDULE PROGRESS PAYMENT SCHEDULE PROJECT PHASE ACCEPTANCE CRITERIA PAYMENT % Phase 1 Purchase of suitable Rhesus Monkeys and successful completion of Experiment 1, Part 1, and Experiment 1, Part 2. Will be deemed successful when all samples from Experiment 1 are shipped to NCTR in a manner appropriate for analysis. 40% Phase 2 Successful completion of Experiment 2, Trimester 1. All samples from both oral and IV dosing obtained at Trimester 1 are shipped to NCTR in a manner appropriate for analysis. 20% Phase 3 Successful completion of Experiment 2, Trimester 2. All samples from both oral and IV dosing obtained at Trimester 2 are shipped to NCTR in a manner appropriate for analysis. 20% Phase 4 Successful completion of Experiment 2, Trimester 3. All samples from both oral and IV dosing obtained at Trimester 3 and before parturition are shipped to NCTR in a manner appropriate for analysis. 20% Background: The FDA, National Center for Toxicological Research (NCTR), Jefferson, AR has a requirement for Pharmacokinetic Analysis of Toxicants in NHPs (Rhesus Macaques of Indian Origin). As part of these analyses, the NCTR has the need to conduct the following experiments described in the Objectives section below. Objectives: Animal requirements: The contractor shall supply sixteen (16) nulliparous or sixteen (16) primiparous female Rhesus macaques monkeys of Indian origin. The animals shall be drug naïve (with the exception of anesthesia), between the ages of 3 and 5 years old, weigh between 6.0 and 7.5 kg, and demonstrate fertility by evidence of continued estrous cycles for at least six (6) months. The animals shall be conditioned prior to the initiation of the study such that dosing and blood collection may be accomplished without the use of anesthesia. In addition to the requirements above, the following health requirements for the test subjects shall be met: (1) All monkeys shall test negative for the following pathogens within one-to-two months prior to the initiation of the study: (1) Tuberculosis; (2) Cercopithecine herpes virus 1 (B virus); (3) SRV/D (Simian Retrovirus type D); (4) SIV (Simian Immunodeficiency Virus); (5) STLV-1 (Simian T-Lymphotropic Virus-1). (2) All monkeys shall either (1) have been vaccinated against measles as a juvenile or (2) be vaccinated against measles within one-to-two months prior to the initiation of the study. (3) All monkeys shall be examined by a licensed Doctor of Veterinary Medicine (DVM), experienced in NHP medicine and surgery, and found to be in good health within one month prior to the initiation of the study. (4) Health records and documentation of testing/treatment for all monkeys shall be provided to the NCTR Attending DVM before the initiation of the study. (5) Monkeys shall be tested for Shigella, Salmonella, Campylobacter, Yersinia, and helminth & pathogenic protozoal parasites within one month prior to the initiation of the study. Treatment regimens for any monkeys testing positive for these organisms shall be discussed with the Principal Investigator (PI) before initiation of treatment. Animal facilities: The animals shall be maintained in a US-based facility that is accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC). Further, the contractor shall supply the NCTR Institutional Animal Care and Use Committee (IACUC) with a copy of the contractor's internal IACUC approved protocol with signatures. Test Article: The test article will be purchased by NCTR as will the vehicle for both the oral and Intravenous (IV) dosing. The test article and the vehicles will be provided to the test facility for use in the study. Using an NCTR-provided procedure, the test article shall be dispersed in the appropriate vehicles at the specified concentrations at the test facility. An aliquot of each dosing solution shall then be shipped to NCTR for dose certification prior to its use. The test facility shall be located in the continental US such that the dose solution samples can be shipped overnight to NCTR by courier within 72 hours of preparation at the test facility. The dose solution samples shall be shipped only after arrangements have been made with the NCTR PI. Sample collection: All samples shall be collected into sample collection tubes provided to the test facility by the NCTR. Approximately 300 - 500 µl (± 10%) of blood shall be collected per time point. After blood collection, each blood tube shall be inverted several times as prescribed by the tube manufacturer and centrifuged for 10 minutes at 1,300 g (or as indicated on the tube/packing) in order to separate plasma. Plasma from each tube/sample (approximately 100 - 150µl) shall be transferred into pre-labeled cryotubes provided to the test facility by NCTR and stored frozen until shipping. The frozen samples shall be stored under conditions whereby the samples are continuously maintained in the frozen state. The frozen samples shall be shipped to NCTR in dry ice by overnight courier no more than 45 days after collection. The plasma samples shall be shipped only after arrangements have been made with the NCTR PI. Experimental Design: In addition to the experiments described below, the test subjects shall be weighed weekly during the experiment and the data forwarded to the PI at the end of Experiment 1 and at the end of Experiment 2. The number of biscuits consumed on a daily basis shall also be recorded and the data forwarded to the PI at the end of Experiment 1 and at the end of Experiment 2. A log of the precise times (to the nearest minute) of the test article administrations and blood collections shall be provided to NCTR with each set of samples. Experiment 1 (Pre-pregnancy pharmacokinetics analyses): The sixteen females identified above and assigned to the experiments shall be treated with the test article as described below: Part 1. Eight (8) animals shall be exposed to the test article by IV (Group 1) one week after the completion of visible estrous. The IV dosing solution shall be injected in a controlled, steady manner with a time frame not to exceed two minutes, the length (time) of the injection recorded and the timing of the blood sample collection begun at the end of the injection. Blood samples shall be taken at the following time points after the end of the injection: IV Sample Collection Times: • 30 minutes pre-dosing • 5 minutes post-dosing • 15 minutes post-dosing • 30 minutes post-dosing • 60 minutes post-dosing • 2 hours post-dosing • 4 hours post-dosing • 6 hours post-dosing • 8 hours post-dosing • 12 hours post-dosing • 16 hours post-dosing • 20 hours post-dosing • 24 hours post-dosing • 36 hours post-dosing • 48 hours post-dosing After IV dosing and sample collection is complete, each of the eight (8) animals shall be housed in the facilities as stated above and checked weekly for signs of the next estrous cycle. One week following the completion of visible estrous, the animals shall undergo oral dosing with the test article. Oral dosing shall be accomplished with the use of an oral dosing syringe. The dosing shall occur according to the following schedule: Oral Dosing Times: Day 1 - AM Dose to be followed 12 hours later by the PM Dose Day 2 - AM Dose to be followed 12 hours later by the PM Dose Day 3 - AM Dose to be followed 12 hours later by the PM Dose Day 4 - AM Dose to be followed 12 hours later by the PM Dose Day 5 - AM Dose to be followed 12 hours later by the PM Dose Sample Collection Times for Oral Dosing: Day 1 - • 30 minutes before AM dosing • 5 minutes post-AM dosing • 15 minutes post-AM dosing • 30 minutes post-AM dosing • 60 minutes post-AM dosing • 2 hours post-AM dosing • 4 hours post-AM dosing • 6 hours post-AM dosing • 8 hours post-AM dosing • 11.5 hours post-AM dosing Day 2 - • 30 minutes before AM dose Day 3 - • 30 minutes before AM dose Day 4 - • 30 minutes before AM dose Day 5 - • 30 minutes before AM dose • 30 minutes before PM dose • 5 minutes post-PM dose • 15 minutes post-PM dose • 30 minutes post-PM dose • 60 minutes post-PM dose • 2 hours post-PM dose • 4 hours post-PM dose • 6 hours post-PM dose • 8 hours post-PM dose • 11.5 hours post-PM dose • 16 hours post-PM dose • 20 hours post PM dose • 24 hours post PM dose • 36 hours post PM dose • 48 hours post PM dose Upon completion of the oral dosing, the eight (8) animals shall be housed as stated above until the next estrous cycle is apparent. The animals shall be time-mated and monitored for signs of pregnancy. Pregnancy will be confirmed by the use of Doppler ultrasound. Part 2. Eight (8) animals shall be exposed to the test article by oral dosing (Group 2); to be initiated one week after the completion of visible estrous. Oral dosing shall be accomplished with the use of an oral dosing syringe. The dosing will occur according to the following schedule: Oral Dosing Times: Day 1 - AM Dose to be followed 12 hours later by the PM Dose Day 2 - AM Dose to be followed 12 hours later by the PM Dose Day 3 - AM Dose to be followed 12 hours later by the PM Dose Day 4 - AM Dose to be followed 12 hours later by the PM Dose Day 5 - AM Dose to be followed 12 hours later by the PM Dose Sample Collection Times for Oral Dosing: Day 1 - • 30 minutes before AM dosing • 5 minutes post-AM dosing • 15 minutes post-AM dosing • 30 minutes post-AM dosing • 60 minutes post-AM dosing • 2 hours post-AM dosing • 4 hours post-AM dosing • 6 hours post-AM dosing • 8 hours post-AM dosing • 11.5 hours post-AM dosing Day 2 - • 30 minutes before AM dose Day 3 - • 30 minutes before AM dose Day 4 - • 30 minutes before AM dose Day 5 - • 30 minutes before AM dose • 30 minutes before PM dose • 5 minutes post-PM dose • 15 minutes post-PM dose • 30 minutes post-PM dose • 60 minutes post-PM dose • 2 hours post-PM dose • 4 hours post-PM dose • 6 hours post-PM dose • 8 hours post-PM dose • 11.5 hours post-PM dose • 16 hours post-PM dose • 20 hours post PM dose • 24 hours post PM dose • 36 hours post PM dose • 48 hours post PM dose After oral dosing and sample collection is complete, each of the eight (8) animals shall be housed in the facilities as stated above and checked weekly for signs of the next estrous cycle. One week following the completion of visible estrous, the eight (8) animals shall undergo IV dosing of the test article. The IV dosing solution shall be injected In a controlled, steady manner with a time frame not to exceed two minutes, the length (time) of the injection recorded and the timing of the blood sample collection begun at the end of the injection. Blood samples shall be taken at the following time points after the end of the injection: IV Sample Collection Times: • 30 minutes pre-dosing • 5 minutes post-dosing • 15 minutes post-dosing • 30 minutes post-dosing • 60 minutes post-dosing • 2 hours post-dosing • 4 hours post-dosing • 6 hours post-dosing • 8 hours post-dosing • 12 hours post-dosing • 16 hours post-dosing • 20 hours post-dosing • 24 hours post-dosing • 36 hours post-dosing • 48 hours post-dosing Upon completion of the IV dosing, the eight (8) animals shall be housed as stated above until the next estrous cycle is apparent. The animals shall be time mated and monitored for signs of pregnancy. Pregnancy shall be confirmed by the use of Doppler ultrasound. Experiment 2 (Pregnancy Pharmacokinetics Analyses). The two sampling groups shall be maintained separately throughout Experiment 2. To clarify, the animals that underwent IV followed by oral dosing (Group 1) shall always undergo IV dosing first, followed by oral dosing. The animals that underwent oral dosing first followed by IV dosing (Group 2) shall always undergo oral dosing first, followed by IV dosing. Animals: The first four (4) females from Group 1 and the first four (4) females from Group 2 that are confirmed as pregnant by ultrasound shall be assigned to Experiment 2. The PK analyses (dosing and blood collection) shall be conducted once each trimester (date of mating is Day 0 of pregnancy). The remaining four (4) females from Group 1 and the remaining four (4) females from Group 2 shall be returned to the contractor once it is determined that they will not be assigned to Experiment 2. Group 1 animals shall undergo IV dosing on Day 30 (Trimester 1), Day 75 (Trimester 2), and Day 130 (Trimester 3) of pregnancy. After sample collection for the IV dosing, the animals shall undergo a minimum one-week rest period. The oral dosing for Group 1 shall begin on Day 45 (Trimester 1), Day 90 (Trimester 2), and Day 145 (Trimester 3) of pregnancy. Group 2 animals will begin oral dosing on Day 30, Day 75 and Day 130 of pregnancy. After sample collection for the oral dosing for Group 2, the Group 2 animals will undergo a minimum one week rest period. IV dosing will occur on Day 45, Day 90, and Day 145 of pregnancy. Dosing and Sample Collection times for Experiment 2: Sample collection times for IV Dosing: • 30 minutes pre-dosing • 5 minutes post-dosing • 15 minutes post-dosing • 30 minutes post-dosing • 60 minutes post-dosing • 2 hours post-dosing • 4 hours post-dosing • 6 hours post-dosing • 8 hours post-dosing • 12 hours post-dosing • 16 hours post-dosing • 20 hours post-dosing • 24 hours post-dosing • 36 hours post-dosing • 48 hours post-dosing Oral Dosing Times: Day 1 - AM Dose to be followed 12 hours later by the PM Dose Day 2 - AM Dose to be followed 12 hours later by the PM Dose Day 3 - AM Dose to be followed 12 hours later by the PM Dose Day 4 - AM Dose to be followed 12 hours later by the PM Dose Day 5 - AM Dose to be followed 12 hours later by the PM Dose Sample Collection Times for Oral Dosing: Day 1 - • 30 minutes before AM dosing • 5 minutes post-AM dosing • 15 minutes post-AM dosing • 30 minutes post-AM dosing • 60 minutes post-AM dosing • 2 hours post-AM dosing • 4 hours post-AM dosing • 6 hours post-AM dosing • 8 hours post-AM dosing • 11.5 hours post-AM dosing Day 2 - • 30 minutes before AM dose Day 3 - • 30 minutes before AM dose Day 4 - • 30 minutes before AM dose Day 5 - • 30 minutes before AM dose • 30 minutes before PM dose • 5 minutes post-PM dose • 15 minutes post-PM dose • 30 minutes post-PM dose • 60 minutes post-PM dose • 2 hours post-PM dose • 4 hours post-PM dose • 6 hours post-PM dose • 8 hours post-PM dose • 11.5 hours post-PM dose • 16 hours post-PM dose • 20 hours post PM dose • 24 hours post PM dose • 36 hours post PM dose • 48 hours post PM dose At the completion of dosing and the collection of all samples, the animals shall be removed from the experiment and reassigned according to the needs of the contractor. Government-Furnished Materials (GFM): The Government will provide the Test Article (i.e., the drug we are testing) and the vehicle to the successful Offeror's test facility within 10 working days after the Offeror has demonstrated the female Rhesus Monkeys are fertile (expected to take place approximately six months 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 Objectives section, the dose solution samples shall be shipped to: HHS/FDA/NCTR, 3900 NCTR Rd., Jefferson, AR 72079. Period of Performance: Estimated to be 15 months after contract 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, 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) This clause implements the temporary policy provided by OMB Policy Memorandum M-12-16, Providing Prompt Payment to Small Business Subcontractors, dated July 11, 2012. (a) Upon receipt of accelerated payments from the Government, the contractor is required to make accelerated payments to small business subcontractors to the maximum extent practicable after receipt of a proper invoice and all proper documentation from the small business subcontractor. (b) Include the substance of this clause, including this paragraph (b) in all subcontracts with small business concerns. (c) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act. 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) 352.231-71 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: nctrinvoices@fda.hhs.gov. 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. 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: (b) 52-203-6, 52.204-10, 52.209-6, 52.219-6, 52.219-8, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37; 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-13-223-1115874. The quotes are due in person, by postal mail or email to the point of contact listed below on or before July 12, 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. Please note that any questions related to this solicitation are due to Scott Rawls via e-mail NLT July 9, 2013, by 1600 hours (Central). 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.
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FBO.gov Permalink
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- Place of Performance
- Address: Contractor's Facility (TBD), United States
- Record
- SN03108363-W 20130706/130704233521-c9a145cd131cbbf97751db19fa559024 (fbodaily.com)
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