Frozen Human Serum

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Q&A - Amendment II - The purpose of amendment II is to respond to industry inquiries.

Question: Is accreditation as a Certified Reference Material producer required? We have ISO 13485, but the term "Certified Reference Material" is often associated with a different standard.

Response: No, NIST is the Certified Reference Material (CRM) producer. The vendor would be provideing the material and NIST is responsible for converting it to a CRM. The ISO 13485 requirement is sufficient for the vendor.

Question: Is filling/capping under nitrogen required?

Response: Yes.

Question: Is a storage condition of -60C sufficient?

Response: No. Storage conditions of -80 degrees C are required to maintain stability.

Question: The requirement states each unit of single-donor serum shall be analyzed to ascertain the 25(OH)D2, 25(OH)D3, and total 25(OH)D concentrations. Is it acceptable for only the pooled matrix to be analyzed to ascertain the 25(OH)D2, 25(OH)D3, and total 25(OH)D concentrations?

Response: While NIST is mainly concerned with the 25(OH)D2, 25(OH)D3, and total 25(OH)D concentrations of the pooled materials for each level, we expect that the vendor would need to screen a significant number of single-donor serum for 25(OH)D2 and 25(OH)D3 to design the pools to obtain the specific targets for each.

Question: Would this be a one-time order, or will you be intending to reorder this?

Response: This would be a one-time order. NIST does not anticipate procuring a smiliar material for at least another five (5) years.

All other terms and conditions remain unchanged, as a result of the amendment.

Q&A - Amendment I - The purpose of amendment I is to respond to an industry inquiry.

Question: The description states crimp vials with 4 different color crimp seals. We do not use crimp seals much anymore and I’m not even sure we can get them in 4 different colors. Are screw cap vials acceptable?

Response: No, screw cap vials are not acceptable.

All other terms and conditions remain unchanged, as a result of this amendment.

COMBINED SYNOPSIS/SOLICITATION 1333ND25QNB640292

SRM 972b Vitamin D Metabolites in Frozen Human Serum

This is a combined synopsis/solicitation for commercial items prepared in accordance with the

format in FAR Subpart 12.6- Streamlined Procedures for Evaluation and Solicitation for Commercial

Items, as supplemented with additional information included in this notice. This announcement

constitutes the only solicitation; quotations are being requested, and a separate written

solicitation document will not be issued. This solicitation is being issued under the authority of

FAR Part 13, Simplified Acquisition Procedures.

This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated

provisions and clauses are those in effect through the Federal Acquisition Circular (FAC) 2025-04

effective 6/11/2025.

The associated North American Industrial Classification System (NAICS) code for this procurement is

325414, with a small business size of 1,250 employees. This acquisition will use Small Business

Set-Aside procedures.

The National Institute of Standards & Technologies Organic Chemical Metrology Group requires Frozen

Human Serum Standard Reference Material (SRM) 972b, in accordance with the attached

Statement of Requirements.

Attachments/Links