SOURCES SOUGHT
88 -- Pharmacokinetic Analysis of Toxicants in Non-Human Primates (Rhesus Monkeys of Indian Origin)
- Notice Date
- 4/29/2013
- Notice Type
- Sources Sought
- 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
- FDA1115874
- Archive Date
- 5/28/2013
- 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
- Total Small Business
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL SOLICITATIION This is a sources sought notice to determine the availability and capability of small business breeders or small businesses capable of supplying a U.S. bred product of a small business breeder. The associated North American Industry Classification System (NAICS) Code is 112990 - All Other Animal Production; Small Business Size Standard is $0.75M. BACKGROUND AND OBJECTIVES: Background: The U.S. Food and Drug Administration (FDA), is conducting market research to support the National Center for Toxicological Research (NCTR), Jefferson, AR requirement for Pharmacokinetic Analysis of Toxicants in Non-Human Primates, NHP (Rhesus Macaques of Indian Origin). As part of these analyses, the NCTR has the need to conduct the following experiments described in the below "DRAFT" Statement of Objectives (SOO): 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 Groups 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. Responses to this sources sought notice shall, at a minimum, provide capability statements to include current in-house capability and capacity to meet this requirement and a list of three prior completed projects of the same nature within the past three (3) years, including date(s) of sale, description, dollar value, client name, client address, client point of contact name, client point of contact mailing address, client point of contact phone number, and client point of contact email address. Respondents shall indicate DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc) pursuant to the applicable NAICS code identified in this notice. In addition, the Government recommends and would appreciate vendors providing a "no obligation" cost estimate for the above referenced requirements for "information purposes" only. The Government is not responsible for locating or securing any information, not identified in the response. Capability statements are due in person, by postal mail or email to the point of contact listed below on or before May 13, 2013, by 12:00 hours (Central Standard Time in Jefferson, Arkansas), at the Food and Drug Administration, Office of Acquisitions & Grants Services, Attn: James "Scott" Rawls, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502 or email james.rawls@fda.hhs.gov. Reference FDA1115874. Disclaimer and Important Notes. 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 submitted. 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. Confidentiality. 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)."
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA1115874/listing.html)
- Place of Performance
- Address: Successful Vendor Location, United States
- Record
- SN03047361-W 20130501/130429234034-d25b8569f667d5b138590f8ff4fff323 (fbodaily.com)
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