D_CSS_Attachment_Brand_Name_Justification_Redacted.pdf

Sole Source Justification Under Simplified Procedures for Certain Commercial Items in Accordance with FAR 13.5

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) / National Institute on Drug Abuse (NIDA).

b. Sponsoring organization. National Center for Advancing Translational Sciences (NCATS) / Division of Preclinical Innovation (DPI) / Stem Cell Translational Laboratory

(SCTL).

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.

The purpose of this acquisition is to obtain assorted proteins and small molecules manufactured by Research and Diagnostic Systems, Inc. (R&D Systems, Inc) for the Stem Cell Translational Laboratory (SCTL) within the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH). As part of the Helping to End Addiction Long-term (HEAL) Initiative, the SCTL is engaged in research projects on understanding molecular mechanisms regulating stem cell pluripotency and their multi-lineage differentiation capabilities with a focus on defining optimum culture conditions for maintaining pluripotent stem cells and their conversion to homogeneous and mature population of differentiated cells.

The assorted proteins and small molecules are needed in these HEAL research projects and will help SCTL scientists to understand the molecular mechanisms that regulate stem cell pluripotency and their multi-lineage differentiation capabilities, specifically focusing on defining optimum culture conditions.

b. Project background. Proteins and small molecules manufactured by R&D Systems, Inc. have been purchased

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

a. Project title. Assorted proteins and small molecules

Solicitation No. 75N95019Q00136

b. Project description. NCATS seeks to purchase assorted proteins and small molecules for projects aimed at understanding molecular mechanisms regulating stem cell pluripotency and their multi-lineage differentiation capabilities with a focus on defining optimum culture conditions for maintaining pluripotent stem cells and their conversion to homogeneous and mature population of differentiated cells. These ongoing projects are being conducted to support the Helping to End Addiction Long-term (HEAL) Initiative. The specific proteins and small molecules needed are listed in the below table.

Item

Catalog Number Unit Quantity

1 Dibutyryl-cAMP, sodium salt 1141 50mg 150 2 L-Ascorbic Acid 4055 50mg 150 3 Dorsomorphin dihydrocloride 3093 50mg 10 4 A 83-01 2939 50mg 20 5 Y27632 dihydrochloride 1254 10mg 30 6 SAG 21k 5282 10mg 20 7 CHIR 99021 trihydrochloride 4953 4953 50mg 70 8 Recombinant Human/Mouse/Rat Activin A Protein 338-AC 50ug 120 9 Recombinant Human BMP-4 Protein 314-BP 50ug 120 10 Recombinant Human Oncostatin M (OSM) Protein 295-OM 50ug 140 11 LDN 193189 dihydrochloride 6053 50mg 20 12 Recombinant Human GDNF Protein, CF 212-GD/CF 50ug 100 13 Recombinant Human beta-NGF Protein, CF 256-GF/CF 100ug 110 14 Recombinant Human NT-3 Protein, CF 267-N3/CF 25ug 60 15 SU 5402 3300 1mg 20 16 DAPT 2634 10mg 20 17 Recombinant Human Jagged 1 Fc Chimera Protein, CF 1277-JG 50ug 30 18 Recombinant Human PDGF-AA Protein, CF 221-AA 50ug 30 19 Recombinant Human DLL1 Protein, CF 1818-DL 50ug 30 20 Recombinant Human CNTF Protein 257-NT 50ug 30 21 Recombinant Human LIF Protein 7734-LF 25ug 50 22 Recombinant Human Cardiotrophin-1 (CT-1) Protein 612-CD 50ug 10 23 Recombinant Human BMP-10 Protein 2926-BP 25ug 30 24 PD 173074 3044 10mg 20 25 Sodium butyrate 3850 50mg 10 26 trans-ISRIB 5284 50mg 50 27 Recombinant Human BDNF Protein, CF 248-BDB/CF 50ug 50

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D)

X Supplies/equipment

Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

X New requirement Follow-on Other (specify): ______________________

Proposed contract/order type.

X 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 (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number. The requisition number for this requirement is 5249962. The POTS Order is 19-002454. There is no proposed solicitation number at this time.

c. Total estimated dollar value and performance/delivery period. The total estimated dollar value for this acquisition is The total delivery period is three months and two weeks after receipt of order. Delivery must occur in two separate shipments:

Shipment 1 is to occur within two weeks after receipt of order and Shipment 2 is to occur three months after Shipment 1. Separate shipments are required due to the shelf life and expiration dates of the proteins and small molecules, and the storage and space constraints in the SCTL laboratory. The quality of proteins and molecules is compromised past their shelf lives or expiration dates, and using compromised proteins or molecules would jeopardize the quality of data and reproducibility of experiments.

These proteins and molecules also have specific storage conditions (-30°C freezer, +4°C refrigerator, room temperature, etc.) and the limited storage in the SCTL laboratory is insufficient to store all of the required proteins and molecules in addition to the contents currently being stored.

4. Statutory Authority Permitting Sole Source. This acquisition is conducted in accordance with FAR 13.501(a) and 41 U.S.C. 1901.

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(s).

Research and Diagnostic Systems, Inc. (R&D Systems, Inc.)

614 McKinley Place NE Minneapolis, MN 55413-2610

Fisher Scientific Company L.L.C.

300 Industry Drive Pittsburgh, PA 15275-1001

VWR International, LLC 2039 Center Square Road Bridgeport, NJ 08014

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

The required proteins and molecules must all be from the same manufacturer, and must be from the same manufacturer as the proteins and molecules currently being used for these projects. Purity and consistency of the proteins and molecules, as well as consistency between batches, are essential to ensuring consistent growth and viability of the cells. NCATS has used recombinant human proteins from R&D Systems, Inc. for the majority of cells used in assays since its inception. Re-optimization of all existing assays would need to be performed if another manufacturer’s medium were to be introduced, which would be cost-prohibitive in terms of funds, time, and material resources. To ensure the continuity of science, the required proteins and small molecules must be manufactured by R&D Systems, Inc.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies. A non-competitive combined synopsis/solicitation will be posted on FedBizOpps along with the requisite brand-name justification. The three capable vendors will also be contacted individually as notification of the combined synopsis/solicitation.

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

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.

Numerous methods of market research have been conducted over the previous 12 months to identify the best acquisition approach to acquire proteins and small molecules from R&D Systems, Inc. Previous procurements were reviewed and additional information was obtained.

A Sources Sought Notice was published on FedBizOpps and no responses were received.

The manufacturer was contacted about authorized resellers and the two resellers were identified. The Contract Directory was searched and no available IDVs were identified. The GSA eLibrary was reviewed and R&D Systems Inc. is not listed as a manufacturer on any GSA Schedule contract.

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

There are no additional supporting facts.

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. No actions are planned. For proteins and small molecules required for ongoing projects, only the same manufacturer can reasonably meet the Government’s needs due to specific medium used to create the proteins and molecules. Using another manufacturer’s medium would jeopardize project results and their ability to contribute to the success of the HEAL Initiative, unless resource-prohibitive re-optimization of all ongoing assays is completed.

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

Project Officer

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

Jeffrey Schmidt Section Head

Jeffrey R.

Schmidt -S

Digitally signed by Jeffrey R.

Schmidt -S Date: 2019.04.12 14:26:54 -04'00'