JA_Envigo (Signed)_Redacted.pdf

Justification and Approval for Sole Source (J&A) **Source Selection Information – see FAR 2.101 and 3.104**

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. Department of Health and Human Services (HHS/ National Institutes of Health (NIH)

b. Sponsoring organization. National Institute of Environmental Health Sciences (NIEHS)/Division of Intramural Research (DIR)

c. Project Officer Information.

Project Officer Name.

Mailing address.

E-mail address.

Telephone number.

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

This justification provides the rationale for contracting by other than full and open competition to award a sole-source bi-lateral contract as a follow on to Contract number 75N96019D00002 with Envigo.

The purpose of this procurement is to continue acquisition of barrier reared and maintained, rats, mice, hamsters, gerbils, and specialized animal services for the NIEHS. The Comparative Medicine Branch (CMB), Animal Resources Section (ARS), is responsible for the centralized ordering of rodents and for the National Institute of Environmental Health Sciences (NIEHS). The ARS maintains procurement mechanisms with several commercial contractors for laboratory animals and animal services to support the research requirements of investigators within the NIEHS Intramural Research Program.

This centralized purchasing mechanism is used for the following functions:

• To provide an efficient and cost-effective centralized purchasing mechanism that can maintain uninterrupted support of the research animal needs of NIEHS intramural investigators.

• To provide monitoring and oversight of the genetic quality and health status of research animals introduced into the NIEHS animal facilities.

• To provide monitoring and oversight of the genetic quality and health status of NIEHS-owned research animals housed and maintained offsite at the commercial contractor’s facilities.

• To maintain compliance with various federal, state, local laws and National Institute of Health (NIH) & NIEHS regulations affecting the use of laboratory animals; and

• 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, Envigo 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 Indefinite Delivery Indefinite Quantity (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 gerbils, which meet the specific genotype, health status, sex, age, weigh, and/or pregnancy requirements and surgical manipulations as requested by individual order to meet the needs of the NIEHS investigators. Other services include, but are not limited to, re-derivation, cryopreservation, cryopreservation storage, quarantine, customized-breeding, colony development, production and maintenance, animal health surveillance and diagnostic testing; genetic monitoring, diagnostic and testing services, veterinary services, customized research protocols and rodent export and import services.

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on Other (specify): __ _____________

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery Indefinite Quantity (IDIQ) Other (specify): ___________ Completion Form Term form

Acquisition identification number.

Pre-Solicitation Number: BRA_Envigo_NIEHS2023

c. Total estimated dollar value and performance/delivery period.

The estimated period of performance is June 16, 2024 through June 15, 2029 plus an option to extend the contract for 6 months to December 15, 2029 in accordance

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

In accordance with FAR 6.302-1 (a)(2), it is determined that the incumbent contractor, Envigo, 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.

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.

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 System Award Management (SAM.gov) on June 1, 2023. No responses were received. 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.

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.