JOFOC.pdf

Justification for Other than Full and Open Competition

Completion Instructions:

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

US Food and Drug Administration, CDER

b. Sponsoring organization.

OPQ/OPQR/DPQRVI

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name:

ii. Mailing address:

iii. E-mail address:

iv. Telephone number:

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

FY24 Domestic Manufacturing: Seg-Flow S3 Agilent Interface

a. Acquisition purpose and objectives.

The objective of the procurement is the purchase and installation of a Seg-Flow S3 Agilent

Interface.

b. Project background.

FDA Office of Product Quality and Research require an interface to integrate our previously installed Seg-Flow S3 (Flownamics) and Ultivo LC-MS (Agilent). This system must integrate communications between both instruments and automatically coordinate in-process samples.

Automatic sampling must be scheduled across multiple vessels and send in-process samples to our Agilent LC-MS for real-time analysis. This interface must be compatible with Seg-Flow S3, Ultivo LC-MS, corresponding software, and future software updates. This interface must include a sample interface kit to allow physical connection between the Sample Mod S3 and Agilent

Online LC.

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

This interface must include a sample interface kit to allow physical connection between the Sample Mod

S3 and Agilent Online LC. Software interface must be compatible, communicate, and schedule in-process samples between the following instruments and software described below.

Seg-Flow S3 (Flownamics) - The Seg-Flow® Automated On-line Sampling System provides allows rapid and accurate sampling for up to 8 vessels or process streams and sample delivery to 4 analyzers and/or fraction collectors.

Agilent Ultivo Triple Quadrupole Infinity LC-MS P/N: G6465BA (Agilent) – Liquid chromatography system and mass spectrometer.

Agilent OpenLabs CDS (Agilent) - OpenLab CDS is a chromatography data system that combines the control of your Agilent LC-MS and data acquisition.

MassHunter (Aglient) - The MassHunter software suite supports efficient data acquisition, qualitative data analysis, mass spectral library management, quantitative data analysis, easy access, and reporting for Agilent LC-MS systems.

a. Project title.

Seg-Flow S3 Agilent Interface

b. Project Description.

Please refer to SOW

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:

Type of action.

☐ New requirement

☒ Follow-on

☐ Other:

Proposed contract/order type.

☒ Firm-fixed-price

☐ Other fixed-price:

☐ Cost-plus-fixed-fee

☐ Other cost reimbursement:

☐ Time and materials

☐ Indefinite delivery:

☐ Other:

☐ Completion Form

☐ Term Form

Acquisition identification number.

Seg-Flow S3 Agilent Interface

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

$45,388.93.00, with performance/delivery period of within 12 months of award.

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

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 United States Code

(U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

☐ 6.302-2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

☐ 6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services. This acquisition is conducted under the authority of United States Code (U.S.C.) 10

U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

☐ 6.302-4 International agreement. This acquisition is conducted under the authority of United

States Code (U.S.C.) 10 U.S.C. 2304(c)(4) or 41 U.S.C. 3304(a)(4).

☐ 6.302-5 Authorized or required by statute. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(5) or 41 U.S.C. 3304(a)(5).

☐ 6.302-6 National security. This acquisition is conducted under the authority of United States

Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

☐ 6.302-7 Public interest. This acquisition is conducted under the authority of United States

Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

☒ 13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain

Commercial Items. This acquisition is using this justification format, modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

Rationale: Flownamics is the only vendor known to date to provide the requested equipment that is capable to perform the requested functions, physically connect to and communicate with the other instrumentation FDA already has in the lab.

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).

Flownamics, Inc.

4902 Pflaum Road

Madison, WI 53718 USA

Tel: 608-310-7590

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

Flownamics is the only vendor known to date to provide the requested equipment that is able to perform the requested functions, physically connect to and communicate with the existing instrumentation in the lab. Flownamics instrumentation (i.e. Seg-Flow S3) shall be 100% compatible with FDA’s existing equipment.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

Following FAR subpart 12.603, OAGS will post this combined synopsis/solicitation on SAM.gov that is access to the public.

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

Contracting Officer will ask the quoter for a redacted invoice from their customer who bought the same item or the quoter’s published price book to prove that the quote is not selling the items more expensive than other customers.

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 into comparable equipment and/or software upgrades that could satisfy all our requirements was conducted, but none were found. Please see attached market research memo.