12. J&A_CRL (Final)_Redacted.pdf

� 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.

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, 2023. 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: NIEHS-BRA2023-CRL

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

The estimated period of performance is June 16, 2024 through and including June 15, 2029 plus an option to extend the contract for 6 months to December 15, 2029 in accordance with FAR 52.217-8. The estimated ceiling/value for this IDIQ contract is 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.

CRL 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 CRL 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.

Market research was performed through a sources sought notice on SAM.gov (posted on June 1, 2023). No responses were received. Based upon this market research, this vendor is the only vendor able to meet the Government�s needs.

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

No. No other company can provide a rodent that has the same unique genetic makeup of this vendor�s rodent which is currently being used for NIEHS research. Therefore, the only responsible source that will satisfy this requirement is this vendor.

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

No other sources have expressed interest in the acquisition.

11. 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.

It is anticipated that this requirement will exist after completion of this contract. At that time, we will re-evaluate programmatic needs to fulfill the requirements.

Market research will also be conducted to request capability statements to ensure no other vendors have become available.

To maintain scientific integrity and continuity of current established and future projects, the use of rats maintained from the same breeding colony are required for research within the program.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or