Amendment 0002 - QA round 2 clarified configuration response date extension - CDRH-OSEL-26-C-D718.pdf

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Benchtop Spectroradiometer System with Flexible Microscope Probes and SDK
Solicitation number
CDRH-OSEL-26-C-D718
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This is Amendment 0002 to a Combined Synopsis/Solicitation (CDRH-OSEL-26-C-D718) issued by the U.S. Food and Drug Administration, Office of Acquisitions and Grants Services for a benchtop spectroradiometer with flexible microscope probes and Software Development Kit (SDK). The amendment publishes questions and answers received from prospective quoters, clarifies the required configuration, and extends the quotation response deadline to Thursday, August 27, 2026, at 12:00 PM Eastern Time. Quotations must be submitted by email to james.jenretteiii@fda.hhs.gov, with any further questions due by Monday, August 24, 2026, at 12:00 PM Eastern Time.

The clarified configuration requires the following deliverables: internal apertures of 2 degrees, 1 degree, and 0.1 degrees; both a 4-foot (or longer) and a 10-foot flexible probe; both ND-1 (10 percent transmittance) and ND-2 (1 percent transmittance) neutral density filters; and flexible probe calibration for a single combination of the 2-degree aperture with 2 nm spectral bandwidth. Quotations must include itemized all-inclusive firm-fixed pricing with shipping included, a minimum sixty-day quotation validity period, a delivery commitment, and a point-by-point statement of compliance against salient characteristics. The evaluation basis is lowest-priced technically acceptable. Previously submitted quotations remain under consideration, but quoters are requested to submit revised quotations reflecting the clarified configuration. All other terms, conditions, requirements, and the evaluation methodology remain unchanged from the original solicitation and Amendment 0001.

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AMENDMENT 0002

Combined Synopsis/Solicitation CDRH-OSEL-26-C-D718

Benchtop Spectroradiometer with Flexible Microscope Probes and SDK

U.S. Food and Drug Administration, Office of Acquisitions and Grants Services

1. Purpose of Amendment

This amendment (a) publishes the questions received from prospective quoters after Amendment 0001, with the Government’s answers; (b) clarifies the required configuration as summarized in Section 3; and (c) extends the quotation response date. Quotations are due no later than Thursday, August 27, 2026, 12:00 PM Eastern Time, by email to james.jenretteiii@fda.hhs.gov. Any further questions are due no later than Monday, August 24, 2026, 12:00 PM Eastern Time.

2. Questions and Answers

Q1. The Statement of Work specifies variable internal apertures of 2 degrees, 1 degree, and 0.1-0.25 degrees. Which aperture in the 0.1-0.25 degree range is required?

A. The third aperture shall be 0.1 degrees. The required internal apertures are 2 degrees, 1 degree, and 0.1 degrees.

Q2. Is the 4-foot or the 10-foot flexible probe required?

A. Both. The quotation shall include one 4-foot (or longer) flexible probe and one 10-foot flexible probe.

Q3. Shall the flexible probe be calibrated for all combinations of aperture and spectral bandwidth, or for a subset?

A. One combination only: the largest aperture (2 degrees) with the narrowest spectral bandwidth (2 nm).

Calibration of all combinations is not required and should not be priced.

Q4. Is the ND-1 or the ND-2 neutral density filter required?

A. Both. The quotation shall include both the ND-1 (10 percent transmittance) and the ND-2 (1 percent transmittance) neutral density filters.

Q5. Is there a minimum measurement spot size associated with the specified apertures?

A. No minimum measurement spot size is specified. The aperture values are requirements in their own right, not a proxy for a measurement spot size, and they stand as specified.

Q6. Must the internal apertures match the specified values exactly, or may the angles be approximated, for example by varying the working distance, to achieve an equivalent measurement area?

A. The specified aperture values shall be provided as internal apertures of the instrument. Approximating the specified angles by varying working distance does not satisfy the requirement.

Q7. Is the 0.125 inch probe tip diameter a maximum, and does a smaller tip qualify?

A. The 0.125 inch dimension need not be matched exactly, and a smaller tip is dimensionally acceptable.

Note that a substantially smaller tip reduces input flux, with consequences for range and accuracy; the offered probe remains responsible for meeting the performance requirements of the Statement of Work.

3. Clarified Configuration

For clarity, a quotation priced to the requirement as amended shall include: internal apertures of 2 degrees, 1 degree, and 0.1 degrees; BOTH the 4-foot (or longer) and the 10-foot flexible probes; BOTH the ND-1 and ND-2 neutral density filters; and flexible probe calibration for the single combination of the 2 degree aperture with the 2 nm spectral bandwidth. All other requirements of the Statement of Work are unchanged.

4. Response Date and Quotations

The quotation due date is extended from August 17, 2026 to Thursday, August 27, 2026, 12:00 PM Eastern Time. Quotations previously submitted remain under consideration; however, because the answers above clarify the required configuration, quoters are requested to submit revised quotations priced to the clarified configuration. The most recent version received by the closing date and time will be evaluated. Revised quotations shall include the items required by the solicitation’s instructions to quoters, including itemized all-inclusive firm-fixed pricing with shipping included, a minimum sixty (60) day quotation validity, a delivery commitment, and a point-by-point statement of compliance against the salient characteristics.

5. All Other Terms

All other terms, conditions, and requirements of the combined synopsis/solicitation, including the Statement of Work, Amendment 0001, and the evaluation basis (lowest-priced technically acceptable), remain unchanged.

6. Point of Contact

James Jenrette, Contracting Officer / Contract Specialist, OAGS: james.jenretteiii@fda.hhs.gov. All communications concerning this solicitation shall be directed to this point of contact in writing.

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