SOURCES SOUGHT
88 -- 8 Non-Human Primates (NHP) - Female Rhesus Monkeys
- Notice Date
- 1/25/2013
- 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
- FDA1113547
- Archive Date
- 2/15/2013
- Point of Contact
- James Scott Rawls, Phone: 8705437540, Regina Williams, Phone: 8705437012
- E-Mail Address
-
james.rawls@fda.hhs.gov, regina.williams@fda.hhs.gov
(james.rawls@fda.hhs.gov, regina.williams@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL SOLICITATIION The U.S. Food and Drug Administration (FDA), is conducting market research to support the National Center for Toxicological Research (NCTR) requirement for 8 Non-Human Primates (NHP). 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: Objective: It is believed that the nonhuman primate 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) have been vaccinated against measles as a juvenile or (2) be vaccinated against measles prior to shipping. 3. All monkeys shall be examined by a Board-licensed Doctor of Veterinary Medicine (DVM), experienced in non-human primate 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, 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 nonhuman primates 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 USAD standards and AAALAC guidelines during transit. 11. The contractor shall start the process to ship and deliver the NHPs 30 days from date of award. 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. 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 January 31, 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 FDA1113547. 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/FDA1113547/listing.html)
- Place of Performance
- Address: National Center for Toxicological Research (NCTR), 3900 NCTR Rd., Jefferson, Arkansas, 72079, United States
- Zip Code: 72079
- Zip Code: 72079
- Record
- SN02973139-W 20130127/130125234939-210cda8407c969b5756533b2f69619b9 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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