ApprovedJOFOC JacksonLab.pdf

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. United States Department of

Health and Human Services (DHHS)/ National Institutes of Health (NIH)

b. Sponsoring organization. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Intellectual & Developmental Disabilities Branch (IDDB)

c. Contracting Officer’s Representative (COR) Information.

1) COR name: Alice Kau, Ph.D.

2) Mailing address: 6710B Rockledge Drive, MSC 7510 Bethesda, MD 20892-7510

3) E-mail address. kaua@mail.nih.gov

4) Telephone number. 301-496-1385

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

a. Acquisition purpose and objectives.

The purpose of this Justification and Approval for Sole Source (J&A) is to award a follow-on contract for an additional five years to produce, maintain, and distribute aneuploid mice with a primary emphasis on models of human trisomy for chromosome 21 (Down syndrome).

b. Project background.

During the last 40 years, various investigators have generated mouse models relevant to Down Syndrome (DS). In order to make these highly complex strains and stocks available to the research community, the creation of a central repository was necessary. The repository ensures that sufficient mice of appropriate genetic backgrounds are maintained and available for distribution to qualified investigators.

This contract has been awarded to The Jackson Laboratory, since 1985. In FY2007, Contract No. N01-HD-73265 in the amount of $3,573,402 was awarded competitively. In 2010, Contract No. HHSN275201000006C was awarded for the period 9/23/10-9/22/15 in the amount of $3,264,477. There were not any other offerors proposing on the last two recompetitions. The competition history was unavailable on the other previous acquisitions. In 2010 and 2015, the contract “A

Justification and Approval for Sole Source (J&A) mailto:kaua@mail.nih.gov

Repository of Mouse Models of Cytogenetic Disorders” was solicited on a full and open basis and awarded to The Jackson Laboratory (JAX). During those acquisitions, there was a substantial increase in investment to ensure timely access to and increased availability of mouse models for cytogenetic disorders, particularly Ts65Dn, to the research community, and to ensure increased experimental efforts to modify the existing genetic backgrounds for the various strains to increase availability and ease of use by investigators.

With the launch of the trans-NIH INCLUDE (Investigation of Co-occurring conditions across the Lifespan to Understand Down syndromE) project in June 2018, there has been a renewed interest in supporting Down Syndrome research in the domains of basic science, cohort development, and clinical trials. To support component 1 of the project, which is focused on conducting targeted, high-risk, high-reward basic science studies to understand chromosome 21 biology and the co-occurring conditions in DS, there is a pressing need to ensure the availability of high-quality murine models of the condition that replicate human traits. Combined with concerns about the Ts65Dn model’s limitations with regard to modeling the human trisomy, it is important that new model(s) also be added to this Mouse Repository.

i. Current Contractor: The Jackson Laboratory (JAX)

ii. Period of Performance: 09/22/2015 – 09/21/2020

iii. Total dollar amount obligated to date: $3,497,749

iv. Awarded Competitively

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

a. Project title.

“Repository of Mouse Models for Cytogenetic Disorders”

b. Project description: See attached Statement of Work.

1) 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 to existing Contract No. HHSN275201500004C Other (specify):

2) 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): Cost - No Fee Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity or requirements):

Other (specify):

Completion Form Term form

3) Acquisition identification number. RFP-NICHD-IDDB-2020-13

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

Period of Performance Amount

9/22/2020-9/21/2021 $649,999 (Base Period) 9/22/2021-9/21/2022 $650,038 (Option Year 1) 9/22/2022-9/21/2023 $650,548 (Option Year 2) 9/22/2023-9/21/2024 $650,031 (Option Year 3) 9/22/2024-9/21/2025 $650,496 (Option Year 4)

Total: $3,251,112

Total Estimated Cost: $3,251,112

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

This acquisition is conducted under the authority of “41 U.S.C.

3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.”

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).

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 (“JAX”) 600 Main Street Bar Harbor, Maine 04609-1500

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

The unique qualifications of this contractor include the following:

1. The Jackson Laboratory (JAX) developed the standard mouse model used in Down syndrome research (“Ts65Dn”) in the research laboratory of one of its founding members. This strain, and many other models for Down syndrome, are difficult to breed because the males are largely infertile and the strain needs to be maintained on a specific mixed background of several parental lineages in order to maintain consistent properties and fidelity. JAX is the only source for these mice in the United States, and while JAX may license them to other international vendors, JAX is the ultimate source for these mice. The complexities of breeding, the rigorous quality control measures needed to maintain the colony, and the regular testing of stocks to ensure their fidelity are unique characteristics of the Jackson Laboratory.

2. Movement of these mice to a different facility (if one existed) and/or interruptions in the provision of these mouse models by JAX would create, for investigators who use these models in their research, a significant disruption their research projects. Because these mice are so sensitive to perturbations in environment and changes in handling, any transition would likely result in at least a 4-6 month lag in mouse availability due to the need to build up the colony at a new site. It would also be costly and counterproductive to the goals of this project.

Award to any other source would result in unacceptable delays in fulfilling the agency’s requirement and result in substantial duplication and an increase in cost to the Government.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a Beta.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 Small Business Sources Sought notice was published in beta.sam.gov on April 6, 2020. A Sources Sought for Other than Small Businesses was published on April 13, 2020. (Copies attached) No responses were received to either of these Sources Sought Announcements. A pre-solicitation notice identifying the Jackson Laboratory as the source and requesting capability statements from any qualified offeror was published for this requirement on June 11, 2020 with responses due on June 26, 2020. (Copy attached) No responses were received.

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

• A cost analysis of the JAX business proposal will be conducted by the Contracting Officer in accordance with FAR 15.404;

• The Contracting Officer’s Representative and Contracting Officer will evaluate all proposed costs then complete and sign the Project Officer Technical Questionnaire (POTQ) form;

• An evaluation of the separate cost elements of the JAX proposal will be compared against the Independent Government Cost Estimate as well as historical contract cost data. (See attached Independent Government Cost Estimate).

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.

The last two full and open acquisition cycles had no interested offerors other than JAX. The COR has determined through her knowledge of the field and her market research through attending scientific meetings that no other sources in the United States exist who have these specific type of mice that are required for the specific research required by the investigators. JAX is the only organization uniquely capable of breeding various strains of mice to serve as models of Down syndrome that are of known genetic background and will produce genetically unbalanced gametes resulting in complete or partial trisomic or monosomic embryos with special emphasis on mouse chromosomes that are syntenic to Hsa21. In addition, a Sources Sought Announcement for Small Businesses and another Sources Sought Notice was posted for Other than Small Businesses were posted. No responses were received. In addition, the 15-day pre-solicitation notice that identified the Jackson Laboratory as our source and asked for and requested capability statements from any qualified source was issued on July 11, 2020, with responses due on June 26, 2020, and no responses were received.

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

Because JAX has served as the repository for mouse models for cytogenetic disorders such as Down syndrome for such a long time, they are the “trusted broker” when new strains are developed by researchers, many of whom are funded by NIH grants. These investigators know that they can trust JAX to reliably breed their strains, cryopreserve embryos for later use, and provide them to the investigator community at reasonable rates, thus fulfilling the requirements for those NIH-funded investigators who have agreed to make their strains available to researchers as part of the terms of their grant. As a consequence, most new strains of mice developed in the U.S. are sent to JAX for this purpose. This is a unique role that no other American breeder can fulfill.

In addition, there would be unacceptable delays in fulfilling the agency’s requirements as there is no other responsible source for these mice. Because these mice are so sensitive to perturbations in environment and changes in handling, any transition would likely result in at least a 4-6-month lag in mouse availability due to the need to build up the colony at a new site. It would also be costly and counterproductive to the goals of this solicitation, if this were even possible.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. No other sources have expressed an interest, in writing, in the proposed 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.

There are currently no future plans to acquire the same type of services. The requirements for this resource are reviewed every five years by senior leadership at NICHD during the institute’s “Operational Planning” process (similar to strategic planning) to determine if its services are still needed, and the progress of and justification for exercising each out-year of the contract is also reviewed annually by leadership.

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 data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature & Date

Contracting Officer’s Representative (COR)

Alice Kau, Ph.D 6/26/2020

COR’s Immediate Supervisor

Melissa Parisi, M.D., Ph.D. 6/26/2020

Head of the Sponsoring Program Office, Acting Associate Director for Extramural Research

Rohan Hazra, MD.

Rohan Digitally signed by Rohan Hazra

Hazra Date: 2020.06.27 16:28:34 -04'00'

13. Contracting Officer Certification

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature & Date

Contracting Officer Elizabeth Osinski Elizabeth J. Osinski Digitally signed by Elizabeth J.

Osinski -S

-S Date: 2020.06.26 15:11:02 -04'00'

Team Leader Daniel Federline Daniel M. Federline Digitally signed by Daniel M.

Federline -S

-S Date: 2020.06.26 15:29:53 -04'00'

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature & Date

Chief of the Contracting Office

Olga Acosta Olga M. Acosta - Digitally signed by Olga M.

Acosta -S

S Date: 2020.06.30 14:53:34 -04'00'

Head of the Contracting Activity

Diane J. Frasier, Director, OALM

FOR

15. Competition Advocate signature.

Official Name & Title Signature & Date

Competition Advocate Dr. Sheryl K. Brining, Director, Strategic Management and Contracts Office, OER