BN JOFOC_CFSAN-2024-121652_CO signed_Redact.pdf

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS)

b. Sponsoring organization.

Office of Regulatory Science (ORS), Division of Analytical Chemistry (DAC), Methods Development Branch (MDB)

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

a. Acquisition purpose and objectives.

The purpose of this requirement is to purchase a SCIEX 5500 + benchtop triple quadrupole-linear ion trap mass spectrometer (QTRAP) for the ORS division.

b. Project background.

The ORS, DAC requires the purchase of one (1) QTRAP for the development of quantitative and qualitative methods in the analysis of contaminants and additives in food/beverage products and food contact materials. The use of a triple quadrupole-linear ion trap mass spectrometer provides enhanced sensitivity and speed requirements, as compared to existing laboratory equipment, that are critical for the development of quantitative analytical methods. In addition to the purchase of this instrument, the Government wishes to obtain a trade-in credit for an existing SCIEX 5500 + hybrid triple quadrupole – linear ION trap mass spectrometer with possible trade in, Serial Number (S/N) AU217281503.

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

a. Project title.

SCIEX 5500 + hybrid triple quadrupole-linear ion trap mass spectrometer (SCIEX QTRAP).

b. Project Description.

ORS has mandated the acquisition of a SCIEX QTRAP facilitate the development of precise quantitative and qualitative methods for contaminants and additives in food and beverage products, as well as materials that come into contact with food. This high-performance technology offers increased sensitivity and speed compared to our current lab equipment, essential for the development of accurate quantitative analysis methods. The manufacturer listed below is the exclusive provider of this instrument, although they have several authorized distributors.

AB SCIEX LLC

1201 Radio Rd

REDWOOD CITY, CA 94065-1217

United States

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.

CFSAN-2024-121652, SCIEX 5500 + hybrid triple quadrupole-linear ion trap mass spectrometer (QTAP); SAM.gov solicitation posting No. 75F40124Q00144.

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

SCIEX QTRAP estimated total cost $364,241.75, plus 1-year warranty commencing from date of installation.

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.

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).

AB SCIEX LLC

1201 Radio Rd

REDWOOD CITY, CA 94065-1217

https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%2013_5.html https://www.acquisition.gov/far/html/Subpart%2013_5.html http://uscode.house.gov/view.xhtml?req=(title%3A41%20section%3A1901%20edition%3Aprelim) http://uscode.house.gov/view.xhtml?req=(title%3A41%20section%3A1903%20edition%3Aprelim)

United States

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

The acquisition of the SCIEX QTRAP system, as specified under FAR 13.501(a)(1)(ii), is a brand name requirement. SCIEX, is the exclusive manufacturer of the QTRAP, and is the only product technically acceptable for the ORS requirement. The QTRAP is a critical component of Mass- Spectrometry-based workflow (MRM3) operations, essential for enhancing data accurately and minimizing matrix interfaces. Due to the incompatibility of other equipment systems with MRM3 workflows, SCIEX remains the sole solution for meeting these specific operational requirements.

The acquisition of the QTRAP system from SCIEX is essential to ensure the quality and reliability of the data generated, and therefore, FDA must rely on this brand name provider to meet our requirements.

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.

The FDA has implemented a comprehensive strategy to ensure that offers are solicited from a wide range of potential sources to the extent practicable. This requirement will be solicited on SAM.gov platform as a brand name. In compliance with FAR 5.102(a)(6), the justification for this requirement will be included with the solicitation posting to promote fairness, transparency, and compliance with federal regulations.

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

The Contracting Officer (CO) anticipates adequate competition is available for this procurement.

Thus, based on expectation of two or more quotes, the CO anticipates the 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.

Market Research identified SCIEX as the Original Equipment Manufacturer (OEM) of the QTRAP. If a patented or copyrighted product is deemed essential for the Government’s needs, it is in the best interest of the government to acquire the product directly from the patent copyright holder, or an authorized reseller. This ensures the unique features and capabilities of the product are obtained effectively and efficiently.

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

N/A

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.

https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/?q=browse/far/10

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.

The agency will take steps to promote competition in acquisitions for future SCIEX QTRAP requirements. Actions will include additional extensive market research, engaging with small businesses, and exploring alternative acquisition strategies. These efforts aim to create a more competitive environment and provide the best value for taxpayers.

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.

Thaddeus A. Digitally signed by Thaddeus A. Benson -S

Benson -S Date: 2024.06.03 Signature: 11:39:51 -04'00'

Thaddeus Benson COR/Requiring Activity POC

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.

Digitally signed by Sheneil R.

Sheneil R. Green -S Green -S

Signature: Date: 2024.06.03 09:36:17 -05'00'

Sheneil R. Green Contracting Officer