BNJ_Cryopreserved_No-Spin_HepaRG.pdf

JUSTIFICATION FOR

SOLE SOURCE/ LIMITED SOURCE/ BRAND NAME & EXCEPTION TO FAIR OPPORTUNITY

1. Agency/Contracting Activity:

HHS/NIH/NIEHS - Office of Acquisitions (QA) 111 TW Alexander Drive Research Triangle Park, NC 27709

2. Description of Action:

(for requirements not-lo◄xceed S 150,000.00)

Nature: [Z]New Requirement D Follow-On Requirement Dodification to Existing - Purchase Order/Contract Number: ______________________ _

Pricing: [Z] Fixed Price D Cost Reimbursement

D Time and Materials / Labor Hour D Other (specify):

3. Procurement History (Continue on page 3 if additional space is needed):

Previous Purchase Order(s) or Contract(s): Oves IZ] No If Yes, Purchase Order/Contract Number: __________ _

Was previous action awarded competitively? Dves D IZ] If No, please summarize ju_stification rationale used:

4. Description of Supplies/Services:

a. Project Title: CRYOPRESERVED NO-SPIN HEPARG (SM CELLSNIAL)

b. Suggested Contractor: Biopredic International (Life Technologies Corporation (L TC) & Lonzaffriangle Research Labs (TRL)

c. The total estimated dollar value of the proposed action is$

d. Period of Performance: 3 to 4 weeks after receipt of order

e. · Description of Requirement (Continue on page 3 if additional space is needed} :

The Biomolecular Screening Branch (BSB) requires up to 400 vials of cryopreserved No-Spin HepaRG cells containing 8 million cells per vial for a large toxicology screening project which is being performed in collaboration with the Environmental Protection Agency (EPA). These cells support primary human hepatocyte-like cell functionality, and are emerging as models to screen chemicals for hepatotoxicity and drug-induced liver injury. More specifically, the request is for No-Spin HepaRG manufactured by Biopredic International.

5. Authority (# 5 will be addressed by OA):

IZ] FAR 13.106-1(b)(1). For purchases, not exceeding the Simplified Acquisition Threshold(� $150,000), if the Contracting Officer determines that only one source reasonably available (e.g. urgency, exclusive licensing agreements, brand name, or industrial mobilization.

FAR 8.405-6(a)(1). For GSA orders with an estimated value excee� the Micro-Purchase Threshold(!: $3,500} the only circumstances that may justify the action are: D (A) An urgent and compelling need exists, LJ(B) Only one source, or 0(C) Logical follow-on to an previously issued GSA order, under which awardees were given fair opportunity to be considered.

FAR 16.5(b)(2). For Task/Delivery Orders under existing IDIQ Contracts, not exceegj_ruJ the Simplified Acquisition Threshold(� $150,000), 0(A) The need is so urgent that providing fair opportunity would result in unacceptable delays; LJ (B) Only one awardee can provide the supplies/services required;

or 0(C) The requirement is a logical follow-on to an order previously issued, under which awardees were given fair opportunity to be considered.

Brand Name. This requirement is for an item that requires a specific brand name, product, or feature of a product, peculiar to one manufacturer, to be awarded using: 0 Simplified Acquisition Procedures (FAR 13}; 0GSA procecures (FAR 8.4}; orO Existing Contracts (FAR 16.5).

6. Rationale and Facts Justifying Details for Not Competing (Continue on page 3 if additional space is needed):

The BSB falls und�r the DNTP and develops and carries out programs in medium and high throughput screening of environmental substances for rapid detection of biological activities of significance to toxicology.

Branch scientists at the BSB strive to improve the relevance of assay findings to human health outcomes, providing data from a variety of high throughput and/or high content approaches and developing computational approaches to best analyze those data. The BSB requires the No-Spin HepaRG which is trademarked by Biopredic International. The cells are cryopreserved after differentiation using a proprietary process developed by Biopredic. The cryopreserved No-Spin HepaRG is a fully-functional, adult-phenotype, human hepatic cell line that does not require centrifugation. {Continued on page 3}

Last Updated: 06/20/2017 Source Selection Sensitive• See FAR 3.104 and 2.101

7. Actions to Increase Competition (Continue on page 3 if additional space is needed):

The NIEHS will monitor relevant literature and publications for other solutions for this requirement. Since there are only 2 US distributors authorized to sell No-Spin HepaRG, competition is limited to the 2 companies.

However, publishing scientific papers in this field may increase demand and competition moving forward.

8. Market Research (Continue on page 3 if additional space is needed):

Market research was conducted via on-line, interactive communication (email), web and library searches, and review of catalogs and other product literature. Market research from mandatory sources revealed no other viable sources. Based on research, Biopredic is the only manufacturer of these cells. Biopredic licensed the No-Spin cells to Lonza and Millipore-Sigma. As such, they can only be purchased from one of the 2 companies.

9. Additional information to support the justification (Continue on page 3 if additional space is needed):

10. Fair and Reasonable Price Determination: As Contracting Officer, I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. Basis for the determination: price analysis techniques.

11. Program Office Certification

The undersigned hereby certify that the portions of this justification that have been developed by the below listed program office personnel, including supporting information and/or data verifying the Government's minimum needs or requirements, or other rationale for sole sources, are accurate and complete.

OFFICIAL SIGNATURE DATE

Project Officer (PO) or Program Official

Project Officer (PO) or Program Official's

NAME, BRANCH/ DIVISION &

TITLE

Immediate Supervisor

12. Contracting Officer Certification and Approval

I hereby certify that this Justification is accurate and complete to the best of my knowledge and belief. Based on the foregoing. I approve this sole source justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition

OFFICIAL SIGNATURE DATE

Contracting Officer

NAME, BRANCH / DIVISION &

TITLE

Source Selection Sensitive - See FAR 3.104 and 2.101