SOURCES SOUGHT
A -- MAINTENANCE OF THE NIAID SPECIFIC PATHOGEN-FREE MACAQUE BREEDING COLONIES
- Notice Date
- 11/18/2015
- Notice Type
- Sources Sought
- NAICS
- 541711
— Research and Development in Biotechnology
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, 3rd Floor, MSC 9821, Bethesda, Maryland, 20892, United States
- ZIP Code
- 20892
- Solicitation Number
- HHS-NIH-NIAID(AI)-SBSS-16-062
- Archive Date
- 12/19/2015
- Point of Contact
- George Ralis, Phone: 301-496-0194, Tom Bahrami, Phone: 301-451-2654
- E-Mail Address
-
ralisg@niaid.nih.gov, bahramit@niaid.nih.gov
(ralisg@niaid.nih.gov, bahramit@niaid.nih.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- Introduction This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases, including immune-meditated rejection of transplanted organs and tissues. Translational studies using nonhuman primate models of pancreatic islet and solid organ transplantation are a key component of the Institute's efforts to increase long-term graft survival and life expectancy, and improve health-related quality of life for transplant recipients. NHP transplantation studies are essential to the design of scientifically sound and ethically acceptable clinical trials, due, in part, to the close approximation of the NHP immune system, genetics and physiology to those of humans. Background The NIAID, Division of Allergy, Immunology, and Transplantation (DAIT) has a requirement for the maintenance, care, expansion and breeding of Government-owned specific pathogen-free (SPF) cynomolgus macaque (Macaca fascicularis) and Indian-origin rhesus macaque (Macaca mulatta) colonies. In addition, the requirement includes provision of up to approximately 300 research-aged SPF progeny a year to designated investigators within the NIAID and National Institute of Diabetes and Digestive Kidney Diseases (NIDDK) Nonhuman Primate Transplantation Tolerance Cooperative Study Group (NHPCSG). The goal of NHPCG, a multi-institution consortium, is to develop and test the efficacy of novel immune tolerance strategies in NHP models of islet and organ transplantation. Preclinical research conducted by the NHPCSG provides critical data required to move promising therapeutic agents from the laboratory into clinical trials. Purpose and Objectives The SPF research progeny from the rhesus and cynomolgus macaque colonies are primarily used for the NHPCSG consortium's research projects. Dedicated colonies allow for the establishment of directed breeding groups to provide progeny of known pedigree and degrees of Major Histocompatibility Complex (MHC) disparity, which is critical to closely replicate clinical transplantation practices. In addition, knowledge of MHC disparity and relatedness between donors and recipients allows for better evaluation of the specific effects of novel regimens when using small experimental groups, as required with nonhuman primate studies. The majority of the colonies have been fully MHC genotyped or the MHC genotype is inferred by MHC-region microsatellite typing when the dam and sire MHC genotypes are known. The NIAID plans to continue the support of the operation, maintenance and expansion of the NIAID macaque breeding colonies. Project requirements The major scope and functions to be performed by the Contractor are to maintain and provide all aspects of care for Government-owned SPF Indian-origin rhesus macaque (Macaca mulatta) and two country-origin cynomolgus macaque (Macaca fascicularis) breeding colonies (herein referred to as rhesus macaque and cynomolgus macaque, respectively), including: • Maintenance, care, expansion (if required), and breeding of the colonies, including all aspects of animal husbandry and medical care. • Provision of up to approximately 240-300 research-aged SPF animals a year at full colony strength. (For purposes of this contract research-age is at least two (2) years and three (3) years for rhesus and cynomolgus macaques, respectively.) • Provision of genetic diversity analysis and planning. • Provision of MHC and/or MHC microsatellite typing in consultation with the Project Officer. • Provision of pedigree analysis. • Maintenance of a comprehensive animal and colony records database that shall be downloaded on a regular basis to the NIAID Bioinformatics Integration Support Contract (BISC) ImmPort database. • Maintenance of continuous full AAALAC accreditation. Additional scope considerations and definitions: • Assume an initial colony strength of approximately 1100 Indian-origin rhesus macaques and 420 Indonesian-origin and 330 Mauritius-origin cynomolgus macaques; • Provision of appropriate housing for the approximate 1850 animals, assuming 55 social groups of between 10 - 70 animals each, and the capability to increase housing as the colonies' sizes increase to enable provision of the approximate 240-300 research-aged animals each year. • Provision of sufficient SPF clinical facilities. • The Contractor shall be financially responsible for all mortalities beyond 10% annually in each individual colony. • For the purpose of this contract SPF is defined as negative for the following viruses: Simian Herpes B virus (Cercopithencine herpesvirus-1, hereafter referred to as B virus), Simian immunodeficiency virus (SIV), Type D Simian Retroviruses (SRV), and Simian T-lymphotropic virus (STLV-1). Fully SPF is defined as a colony negative for, and with no exposure to, all four viruses for greater than or equal to five (5) years. Anticipated period of performance The anticipated period of performance will begin around June, 2017 and continue for seven years. Capability statement / information sought Potential sources must demonstrate and document the following in their capability statements: a) Comply with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals and terms of the Animal Welfare Act of 1970 (P.L. 89-579) and its regulations and amendments. ( http://grants.nih.gov/grants/olaw/references/phspol.htm ). b) Maintain full and continuous accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC; http://www.aaalac.org/accreditation/index.cfm ). A new facility or organization that has Provisional AAALAC Accreditation Status and in line for full accreditation, may submit a proposal to the RFP; however, proposals from an organization/facility that has Probationary Accreditation Status will not be considered responsive to the RFP. c) Maintain US Department of Agriculture Class R Registration for animals covered under the Animal Welfare Act; d) Maintain a current Animal Welfare Assurance number on file with the PHS Office of Laboratory Animal Welfare (OLAW; http://grants.nih.gov/grants/olaw/olaw.htm). e) Conform to the Occupational Health and Safety in the Care and Use of Research Animals for all animal care, biosafety, and occupational health and safety; and The Biosafety in Microbiological and Biomedical Laboratories (CDC-NIH). f) Maintain AAALAC and CDC, if applicable, approved quarantine procedures and precautions at all times, including introduction of animals from domestic and international sources for all the Contractor's sites that share personnel, land, facilities, and/or equipment with the NIAID colonies. g) Notify the NIAID COR within two (2) calendar days of receipt of any changes in AAALAC accreditation status or citations, or any USDA citations. Provide all documentation of citations and actions taken to remedy deficiencies. h) Provide the NIAID COR with copies of all AAALAC and USDA site visit inspection reports and accreditation status within seven (7) calendar days of receipt. i) Maintain full SPF status of all animals within the colonies or purchased animals, including provision of sufficient dedicated SPF housing, quarantine, isolation and clinic facilities. j) Transportation of animals to NHPCSG investigators and potential acquisition of new animals shall meet all applicable State, Federal, and International regulations for shipment, including for all intermediate handlers. Page Limitations: Interested qualified small business organizations should submit a tailored Capability Statement not to exceed 10 pages, excluding resumes. Capability Statements must not include links to internet web site addresses (URLs) or otherwise direct readers to alternate sources of information. Font size must be 10 to 12 points. Spacing must be no more than 15 characters per inch. Within a vertical inch, there must be no more than six lines of text. Print margins must be at least one-inch on each edge of the paper. Print setup should be single-sided on standard letter size paper (8.5 x 11" in the U.S., A4 in Europe). All proprietary information should be marked as such. Required Business Information: • DUNS. • Company Name. • Company Address. • Company Point of Contact, Phone and Email address • Current GSA Schedules and/or Government-wide Acquisition Contracts (GWACs) appropriate to this Sources Sought. • Do you have a Government approved accounting system? If so, please identify the agency that approved the system. • Type of Company (i.e., small business, 8(a), woman owned, veteran owned, etc.) as validated via the System for Award Management (SAM) located at https://www.sam.gov/index.html/#1. This indication should be clearly marked on the first page of your Capability Statement (preferable placed under the eligible small business concern's name and address). Number of Copies: Please submit one (1) electric copy of your response as follows: All Capability Statements sent in response to this Small Business Sources Sought notice must be submitted electronically (via e-mail) to George Ralis, Contract Specialist, at ralisg@niaid.nih.gov in MS Word or Adobe Portable Document Format (PDF). The e-mail subject line must specify HHS-NIH-NIAID(AI)-SBSS-16-062. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 3:00 PM Eastern Prevailing Time on December 4, 2015. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes This notice does not obligate the Government to award an IDIQ contract or Task Order 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)."
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- Record
- SN03949699-W 20151120/151118234934-b7bcfc171054fc66c6ec3c148d2eb830 (fbodaily.com)
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