American National Standards Institute (ANSI) Standards Membership
ID: 75F40126Q00014Type: Special Notice
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONRockville, MD, 20841, US

NAICS

Web Search Portals and All Other Information Services (519290)

PSC

IT AND TELECOM - IT MANAGEMENT SUPPORT SERVICES (LABOR) (DF01)

Set Aside

No Set aside used (NONE)

Original Source

https://sam.gov/workspace/contract/opp/2a276ae3f616481dae765f344df82405/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking to procure a Brand Name American National Standards Institute (ANSI) Standards Membership through a Request for Quotation (RFQ) identified as 75F40126Q00014. The objective of this acquisition is to secure unlimited FDA user access to ANSI standards for a base year and four option years, which is critical for the FDA's regulatory functions, particularly in the area of medical devices. This membership will enable the FDA to maintain access to essential medical device standards and participate in various standards development committees, ensuring compliance with regulatory responsibilities. Interested contractors must submit their fixed-price quotes to Brian Wodzisz via email by 3:00 PM ET on December 30, 2025, with quotes evaluated based on the lowest price technically acceptable criteria.

    Point(s) of Contact
    Brian Wodzisz
    brian.wodzisz@fda.hhs.gov
    Files
    Title
    Posted
    BNJ_ANSI_Redacted.pdf
    The Food and Drug Administration (FDA) is seeking approval for a brand name acquisition of American National Standards Institute (ANSI) membership, justified under Federal Acquisition Regulations (FAR) 13.501(a)(1)(ii) for sole source/brand name procurements. This membership is crucial for the FDA's Center for Devices & Radiological Health (CDRH) to maintain access to medical device standards, participate in standards development committees (e.g., USNC US TAG IEC TC77, ISO TC 338 TAG), and fulfill its regulatory responsibilities in approving medical device premarket applications. ANSI is identified as the sole organization capable of providing these services due to its exclusive designation as the U.S. National Standards Body and its unique role in accrediting U.S.-based standards organizations, ensuring FDA's continued participation in critical national and international standards activities.
    RFQ_Instructions.pdf
    The FDA is issuing a Request for Purchase Order (PO) to renew its American National Standards Institute (ANSI) Standards Membership, identified by Solicitation Number 75F40126Q00014. Interested contractors must submit a fixed-price quote to Brian Wodzisz via email by 3:00 PM Eastern Time on December 30th, 2025. Quotes must be valid for 60 days, submitted in an unsecured format, and include an itemized list with product descriptions, part numbers, and any assumptions. Partial or incomplete quotes will not be considered. The government will evaluate quotes based on total price and technical features meeting or exceeding requirements, with the intent to award a purchase order without discussions. The Statement of Work (SOW) is attached for reference.
    SOL_RFQ_75F40126Q00014.pdf
    The U.S. Food and Drug Administration (FDA) has issued a combined synopsis/solicitation (75F40126Q00014) for a Brand Name American National Standards Institute (ANSI) Standards Membership. This Request for Quotation (RFQ) seeks a commercial item, firm fixed-price purchase order for unlimited FDA user access to ANSI standards for a base year and four option years, spanning from January 21, 2026, to January 20, 2031. The FDA utilizes these standards for regulatory purposes, particularly in medical devices. The membership must provide 24/7 access, support standards policy development, and offer specialized conformity assessment programs. Quotes will be evaluated based on the lowest price technically acceptable criteria, ensuring compliance with technical capabilities, period of performance, and pricing for all line items. Offerors must submit quotes by December 30, 2025, by 3:00 PM ET, and adhere to specific invoicing instructions via the Invoice Processing Platform (IPP) and accessibility standards for Information and Communication Technology (ICT).
    Lifecycle
    Title
    Type
    American National Standards Institute (ANSI) Standards Membership
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