NIAID SPF MACAQUE BREEDING COLONIES

Sources Sought Notice Information 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. Background 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, tissues, and cells. Translational studies using nonhuman primate (NHP) 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. Purpose and Objectives The NIAID Division of Allergy, Immunology, and Transplantation (DAIT) has a requirement for the maintenance, care, breeding, and management of Government-owned specific pathogen-free (SPF) Mauritian cynomolgus macaque (Macaca fascicularis) and Indian-origin rhesus macaque (Macaca mulatta) colonies. This requirement includes provision of approximately 200 research-aged (at least two years for rhesus macaques and three years for cynomolgus macaques) SPF progeny per year to designated investigators (). Because humans are genetically diverse, maintaining outbred NHP colonies retains the value of these animals as translational models. Major Histocompatibility Complex (MHC) genotyping of the animals not only assists in management of genetic diversity, but the setting of transplantation, allows for selection of donor and recipient animals with known degrees of MHC disparity. Knowledge of MHC disparity and relatedness between donors and recipients is necessary to replicate clinical transplantation practices and facilitate rigorous experimental design and data interpretation of NHP studies, which often require small experimental groups. The majority of the NIAID animals are MHC genotyped. NIAID intends to continue to support the operation and maintenance 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 Mauritius-origin cynomolgus macaque (Macaca fascicularis) breeding colonies (herein referred to as rhesus macaque and cynomolgus macaque, respectively), including: Maintenance of full SPF status, care, expansion or contraction (as required to meet research needs), and breeding of the colonies, including all aspects of animal husbandry and medical care. Provision of up to approximately 200 research-aged SPF animals a year at full colony strength. For purposes of this contract research-age is at least two (2) years for rhesus macaques and three (3) years for cynomolgus macaques. Provision of genetic diversity analyses and plans to maintain or improve the genetic diversity of the colonies. Provision of pedigree analyses. Provision of MHC and/or MHC microsatellite typing results in consultation with the Project Officer. Maintenance of a comprehensive animal and colony records database that shall be downloaded on a regular basis to the NIAID ImmPort database. Submission of quarterly and annual reports summarizing contract activities. Maintenance of full AAALAC accreditation. Additional scope considerations and definitions: Assume an initial colony strength of approximately 1300 Indian-origin rhesus and 700 Mauritius-origin cynomolgus macaques; Provision of appropriate housing for approximately 2000 animals, assuming 60 social groups of between 10 - 70 animals each, provision of approximately 200 research-aged animals per year, and the capability to increase housing should colony sizes increase. For the purpose of this contract SPF is defined as negative for four specific viruses: Macacine herpesvirus 1 (B virus), Simian immunodeficiency virus (SIV), Simian betaretrovirus, formerly known as simian retrovirus type D (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. The Contractor shall be financially responsible for all mortalities beyond 10% annually in each individual colony. Unless deemed necessary for the safety and well-being of the colonies, the Government will NOT provide funds to support facility construction or renovation costs. It is expected that the contractor will invest in ongoing structural improvements to its facilities. It is anticipated that one IDIQ type contract will be awarded with an anticipated annual total effort of approximately 56,160 direct labor hours based on 2080 hours per full time equivalent (FTE), and 27 FTEs associated with activities required under Task Area A. Anticipated period of performance The anticipated period of performance will be September 30, 2024, to September 29, 2031. Capability statement/information sought Potential sources must demonstrate the following in their capability statements: Appropriate staff expertise, availability, experience, and formal and/or other training; Current in-house facility capabilities and capacity to perform the work, including ability to maintain full SPF status of all animals within the colonies and any newly introduced/purchased animals in terms of availability of dedicated SPF housing, quarantine, isolation, and clinic facilities; Prior experience accomplishing projects of similar nature. Include references, and other related information; Corporate experience and existing management capabilities including: Compliance 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 ); Full and continuous accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC; http://www.aaalac.org/accreditation/index.cfm ), or if a new facility or organization, Provisional AAALAC Accreditation Status pending full accreditation; US Department of Agriculture Class R Registration for animals covered under the Animal Welfare Act; Maintenance of 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); 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: UEI. 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/SAM/pages/public/index.jsf. 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) electronic 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 75N93023R00001. 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 10/27/2022. 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 at SAM.gov. 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).