Justification_Sole Source to Taconic for NIAID Mouse Repository_Redacted.pdf

acquisition is to continue mouse repository services for a 12-month base period and two 6-month options.

b. Project background.

NIAID has multiple animal housing facilities to support the intramural research program. These facilities are located on the main NIH campus in Bethesda, Maryland, leased facilities in Rockville, Maryland, and the Rocky Mountain Laboratories in Hamilton, Montana. The NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. The laboratory mouse is the most widely used research model in the intramural research program because of the availability of genetically well-characterized strains that mimic the human immune response to immunological challenges; and specific genetic mutations can be created to model genetic diseases of the human immune system.

NIAID researchers have established numerous colonies of congenic, transgenic, gene knockout and various combinations of genetically manipulated mice that are essential for ongoing and future studies of infectious, immunologic, and allergic disease. The animals (live and/or cryo-preserved) are maintained in NIH facilities or an off-site contract facility NIAID mouse repository. The NIAID repository performs large-scale production of mice for the intramural research program. NIAID seeks services to operate the mouse repository to breed and maintain numerous strains of congenic, transgenic, and gene knockout mice for shipment to NIAID facilities for research projects ranging from infectious disease research to cellular immunology. The NIAID repository provides a source of animals from a contractor who has the skills to efficiently carry out large-scale, complex genetic breeding schemes required for the development of these lines for research purposes, and the distribution of these models to domestic and international collaborators and biomedical research institutions.

This requirement was previously negotiated on an other than full and open competition basis with the incumbent contractor, Taconic Biosciences, for the current contract.

Current Contract Contractor: Taconic Biosciences Contract No.: HHSN272201700058C Period of Performance: 09/30/2017-06/10/2023 Total Dollar Amount Obligated: $9,246,059

Predecessor Contract Contractor: Taconic Biosciences Contract No.: HHSN272201200029C

Period of Performance: 09/01/2012-09/29/2017 Total Dollar Amount Obligated: $10,238,353.00

Predecessor Contract Contractor: Taconic Biosciences Contract No.: HHSN272200700044C Period of Performance: 09/01/2007-08/31/2012 Total Dollar Amount Obligated: $12,509,234.00

Predecessor Contract Contractor: Taconic Biosciences Contract No.: N01AO02740 Period of Performance: 09/01/2000-08/31/2007 Total Dollar Amount Obligated: $10,580,558.00

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title: Operation and Maintenance of a Murine Pathogen-Free Mouse Breeding Facility

b. Project description.

The contractor will continue to provide operational and support services for NIAID’s mouse repository to use embryo transfer to derive new strains, breed, maintain, and delivery strains of congenic, transgenic, and gene knockout mice for shipment to NIAID facilities and collaborators as requested as defined in the Statement of Work. Below is a summary of the activities / tasks required under this acquisition:

1. Mouse Breeding

a. Provide a Project Manager and staff experienced in breeding mice

b. Maintain up to 3400 cages of inbred, congenic, transgenic, and DNA-mediated gene targeted mutant mice and their offspring

c. Perform laboratory procedures involved in taking samples of tissues required for genetic typing of the animals.

d. Positively identify animals entering and born in the facility using a reliable tracking system

e. Coordinate and ship mouse “exports” to domestic and international third-party recipients

2. Mouse Care

a. House all re-derived mice in a facility that achieves a minimum double barrier design

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(__) as set forth in Federal Acquisition Regulation (FAR) 6.302- __.

X This acquisition is conducted under the authority 41 United

States Code (U.S.C.) 3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 13.106-1(b)(2) and 13.501(a).

This acquisition is conducted under the authority of the

Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Taconic Biosciences 273 Hover Ave Germantown, NY 12526-5320

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

NIAID requires Taconic Biosciences to continue services to operate and maintain the mice breeding facility and colonies as we prepare to solicit the full and open competition follow-on contract. This sole source award will provide adequate time to develop, advertise, review, and award the successor contract by full and open competition, including the necessary time to transition to a new vendor, if needed. Market research continues to show that Taconic Biosciences is the only contractor that is currently capable of performing this requirement and NIAID needs to ensure there is no break in the continuation of these services.

The only mouse colonies capable of providing for the needs of the NIAID investigators are established, fully functioning colonies, such as those currently held on contract at the Taconic Biosciences facilities. These colonies can fulfill the requirements of having the ability to fulfill mouse orders submitted by NIAID investigators without error or delay. The time to transfer the 120 strains currently held on the contract, rederive them by embryo transfer, perform health testing to validate the health status, and then establish and expand the individual mouse colonies to meet the ongoing NIAID demand would significantly delay critical research performed by NIAID Investigators. Once the colonies have been rederived and receive health clearance, four to six months of data must be analyzed to calculate the breeding proficiency index for each individual strain. This breeding proficiency index is used to determine the size of the breeding colony required for each strain to produce the number, age- and sex of mice needed to meet the NIAID research demand. Once the breeding proficiency data has been obtained, it may take an additional six months to increase the colony to the appropriate size to supply the quantity of animals needed. Any delays created by transporting mice to a new vendor facility and establishing functional colonies would be unacceptable and disruptive to ongoing research.

Every NIAID research project utilizing mouse strains produced at Taconic would be delayed. In addition, +/- 15 years of research data and effort may be lost due to changes in the microbial flora of mice rederived into a new environment. The mice currently on the contract at Taconic have an established flora (microbiota), and up to 20 years of research has been conducted using these mice.

final transition plan will be incorporated into the agreement. For a smooth transition to occur, if applicable, 8–12-week-old male mice and 3–4-week-old female mice of the appropriate genotypes will be shipped to the successor for rederivation at least eight to twelve weeks before the end of the contract. The sequence of strains to be transferred and the numbers of male and female mice to be shipped are dependent on the size of the colony required to provide NIAID with the quantity of mice needed to meet the research demand. For example, more frequently used strains require 250-300 breeding females to meet the ongoing demand of the NIAID research program resulting in a larger number of animals to be transferred to the successor early in the transition, while other colonies require fewer breeding females and may be transferred later in the transition.

Because of the foregoing, NIAID has determined that it is critical to extend the work of the current contract with Taconic Biosciences. This will provide adequate time to solicit a full and open competition follow on award, including the proper timing to accommodate a transition to a new vendor if needed.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps (SAM.gov) notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies.

As required by FAR Subpart 5.2, a Presolicitation Notice of Intent (NOI) to award to Taconic Biosciences on a sole-source basis was published on SAM.gov on April 17, 2023, and closed at 10:00 am EDT on May 2, 2023, and no responses were received. The NOI explained NIAID’s intent to solicit and negotiate with only one source and provided an opportunity for responsible and capable offerors to provide input.

Additionally, an amended notice was published on SAM.gov on May 26, 2023, clos June 1, 2023 at 5:00PM

EDT

Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

An Independent Government Estimate (IGE) has been developed based on the history of the previous contract, current market conditions and program expectations. However, to ensure that the price is fair and reasonable and is in line with the price paid by others in the market, the data from the IGE will be compared with the quote received from the offeror. A final determination by the Contracting Officer will be conducted prior to award of a contract.

Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

The Program Office conducted the initial market research by reviewing NIAID’s existing services with Taconic Bioservices and scanning the market for alternatives. Their research concluded that Taconic is currently the only source for mouse colonies capable of providing for the needs of NIAID investigators. Market research conducted included posting a Sources Sought notice on SAM.gov in January 2022. The sources sought provided an opportunity for businesses to submit a capability statement explaining their ability to fulfill the requirement. In response to the Sources Sought, only one response was received by a large business other than Taconic Bioservices. The company expressed an interest but did not submit a capability statement. Additional market research was conducted online to identify other vendors with capabilities to house and breed rodent models on a scale to meet the needs of NIAID researchers. As discussed in item #6 above, presolicitata ion .

Given the circumstances of this requirement, and based on the results of the market research that was conducted in accordance with FAR Part 10, NIAID intends to solicit this requirement on a sole source basis with the incumbent contractor, Taconic Biosciences, Inc.

Any other facts supporting the use of other than full and open competition.

Last year, NIAID investigators ordered and received over 33,000 mice from the NIAID repository. Given the magnitude of mice being ordered on an annual basis, any time delay in re-establishing the breeding would be highly disruptive for the many NIAID investigators that now depend on regular shipments of mice to maintain the quality and consistency in their experiments.

The significant delays that would result from transferring and reestablishing the already existing mouse repository from Taconic to another service provider mandates the continued maintenance of the current repository until the transition is complete. It would be estimated that the entire transition process would take approximately one year to complete. During this time, it would be necessary to continue the supply of 700 mice per week of various strains to NIAID investigators. This would require that the current contractor (Taconic Biosciences) continue to maintain the existing mouse repository as well as all shipment arrangements with NIAID.

Finally, over the past 20-years numerous repository mouse line embryos and sperm have been cryopreserved by Taconic Biosciences. These embryos are being maintained at their facility as part of our current contract.

Total inventory is approximately 3300 cryovials. Transitioning to another contractor would also mandate the transfer of these embryos to another facility unless a separate agreement was enacted with Taconic Biosciences to continue this service and additional costs would be incurred.

Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources expressed a written interest in the acquisition as explained in Items #6 and #8 of this J&A.

Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

As stated above, under item 5.b., NIAID intends to solicit the subsequent follow-on contract for this requirement using full and open competitive procedures.