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This document is a Justification and Approval (J&A) for a sole-source contract to The Jackson Laboratory for providing barrier-reared rodents, including rats, mice, hamsters, and gerbils, as well as specialized animal services to the National Institute of Environmental Health Sciences (NIEHS).

The J&A states that The Jackson Laboratory is the only responsible source capable of providing the genetically unique rodents required for NIEHS research. Prior to 2013, NIEHS had acquired animals through NIH, but was directed to source its own animals. This requirement has been competed and awarded twice in the past 10 years, with The Jackson Laboratory being the sole awardee each time. The current contract is an IDIQ with a period of performance from December 16, 2018 to June 15, 2024. The estimated total value for the new award is less than the previous contract ceiling of $4,961,748. The J&A cites the rationale for the sole-source justification, including the need to maintain continuity of research using the genetically unique rodent strains provided by The Jackson Laboratory.

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• To ensure that NIEHS Principal Investigators and the Comparative Medicine Branch have authorized the placement of individual animal procurement requests.

The objective of this acquisition is to secure these animals and services for principal investigators at the NIEHS by acquiring specific strains from named vendors to maintain a continuity of research.

b. Project background.

This requirement was initially identified in 2013. Prior to that time, animals for NIEHS were acquired through the Animal Procurement group and Division of Veterinary Resources at NIH. Because NIEHS has a robust program, NIH requested, at that time, for NIEHS to source their own animals using NIEHS funding.

This requirement has been previously competed and awarded two times in the past 10 years. In that time, the same vendor has proposed and been awarded a contract for this requirement. Though this requirement was competed previously, The Jackson Laboratory was the only vendor that could supply these genetically unique mice for the NIEHS.

Currently, there are four (4) types of barrier-reared rodents for NIEHS which are provided by four (4) vendors who each provide a uniquely genetic rodent. The vendors are as follows and each has their own unique contract with NIEHS:

75N96019D00001 – Charles River Laboratories

75N96019D00002 – Envigo

75N96019D00003 – The Jackson Laboratory

75N96019D00004 – Taconic Biosciences

All four contracts were competed full and open and awarded as commercial IDIQ contracts with a period of performance from December 16, 2018 to June 15, 2024. None of the vendors awarded has had known performance problems.

3. Description of the supplies or services required to meet the agency’s needs

(including the estimated value).

a. Project title - Provisions for Barrier Reared and Maintained, Rats, Mice, Hamsters, Gerbils, and Specialized Animal Services

b. Project description.

The contractor shall furnish to the National Institute of Environmental Health Sciences (NIEHS) all or part of the following as specified in their submitted catalog and/or price list: Various strains and stocks of barrier reared and maintained rats, mice, hamsters, and/or

Period Description of

Item(s) or Service(s)

Quantity or Minimum & Maximum

Unit Price

Discount

Total NTE

Price

Base: 6/16/2024 – 6/15/2029 See SOW IDIQ TBD TBD Option to extend 6 mo. FAR 52.217-8 6/16/2029 – 12/15/2029

See SOW IDIQ TBD TBD

Total Base + 6 mo. option ext

The previous award established a total ceiling of $4,961,748.00. This is $461,748 more than the proposed estimate for the new award. This estimate is based on programmatic historical demand for strains specific to this vendor.

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.) 3305 and 3306 as set forth in Federal Acquisition Regulation (FAR) 6.302- (1).

Based on the market research and sources sought notice, posted on June 1, 2023, the identified vendor is the only responsible source determined capable at this time to provide their unique rodent. No other supplies or services will satisfy agency requirements. FAR 6.302-1 (a)(2)(i)(A) and (U.S.C.) 3204.

This acquisition is conducted under the authority of section 4202 of the

Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

This acquisition is conducted under the authority of 41 United States

Code (U.S.C.) 1901 as set forth in Federal Acquisition Regulation (FAR) 13.501(a)(1)(ii)

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.

The Jackson Laboratory 600 Main Street Bar Harbor, ME 04609-1500

b. Nature of the acquisition and proposed unique qualifications of the contractor.

In accordance with FAR 6.302-1 (a)(2), it is determined that the incumbent contractor, Jackson Laboratory, is the only responsible source that can reasonably satisfy the Government’s requirements for the genetically unique rodents used by NIEHS. No other type of supply or services will satisfy agency requirements at this time.

Maintaining continuity of research is a primary concern for this requirement.

Jackson supplies mice with a unique genetic makeup that other vendors cannot match. Most strains and stocks of mice that are available from other vendors have been physically separated from each other for so many generations that they are genetically unique when it comes to their biological response to many research procedures.

While there are several large businesses who are available to provide this service, any specific strain supplied by an individual vendor is genetically unique and cannot be provided by another vendor. These genetic differences will result in different research outcomes. As such, any research study that begins with a specific strain from a specific vendor must continue to obtain this exact strain from the same vendor.

Introduction of even the same strain from a different vendor, would cause a variable to ongoing research as even the slightest change in the genetics would cause this variable. Departing from the sub-strain provided by Jackson risks reduced accuracy, reliability, and reproducibility of research results.

Therefore, the acquisitions office is seeking to sole source this requirement to the vendor currently suppling barrier reared animals and specialized animal services to the NIEHS. By utilizing the incumbent contractor for this requirement, the NIEHS can ensure a continuity of research essential to mission driven work.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a 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.

A sources sought notice was posted to SAM.gov on June 1, 2023. The government also posted a Pre-solicitation notice publicized as a Notice of Intent to Sole-Source on September 25, 2023, IAW FAR 5.2. No responses were received to the sources sought notice or notice of intent to sole-source.

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

The previous COR, and program administration developed an Independent Government Cost Estimate (IGCE) based on the history of the previous contract, current market conditions and program expectations. However, to ensure that the price will be fair and reasonable, the data from the IGCE will be compared with the proposal received from the offeror. An award will be made only if during negotiations; it is shown that the anticipated cost to the government will be fair and reasonable.

The offeror is expected to submit a price proposal for the base year and all option periods of the contract. Previously cost realism was conducted for the prior contract and will be performed on this acquisition as well.

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

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