SAM #FDA-NOI-133411

FDA Sole Source Extension for MQSA Certification and Hotline Support Services

This opportunity is a sole source contract extension from the FDA for continued support of the Mammography Quality Standards Act (MQSA) certification and hotline program. - Sole source, labor hour contract extension for 6 months - Vendor: Impyrian LLC - Scope includes: - Operating and maintaining the MQSA Facility Certificate Issuance system - Managing the MQSA hotline for certification inquiries - Maintaining the database system for scanning mammography certification letters - Providing real-time responses to inquiries from facilities, consumers, inspectors, and stakeholders - Keeping records of all communications - NAICS code: 541511 (Custom Computer Programming Services) - No specific products or part numbers requested; focus is on support services - Place of performance: Fulton, Maryland - Contracting office: FDA facility at 5630 Fishers Lane, Rockville, MD

Description

The Food and Drug Administration (FDA) intends to award a Sole Source labor hour 6-month contract extension to Impyrian LLC, 8115 Maple Lawn BLVD, Suite 260, Fulton, Maryland 20759-2681 for the Mammography Quality Standards Act Program, in accordance with the authority under FAR Part 6 (i.e. 6.103-1, Only One Responsible Source). This procurement is being extended through the acquisition procedures in accordance with FAR Part 52.217-8. The NAICS Code for this action is 541511 – Custom Computer Programming Services.

The primary objective of this requirement is to 1. operate and maintain the current system for the issuance of federal certificates to mammography facilities under the MQSA. 2. Operate and maintain the current MQSA hotline certification inquiries system, including real-time responses, maintaining records of written, telephone, email, and fax inquiries from facilities, consumers, MSQA inspectors and mammography stakeholders. 3. Operate and maintain the current database system to scan all mammography certification letters mailed to facilities.

The scope of the activities supported by this contract requires the Contractor to perform in support of the Mammography Quality Standards Act (MQSA) Facility Certificate Issuance and Hotline Inquiries program functions. DMQS provides technical and administrative information to mammography manufactures (post-marked), mammography facilities, consumers, MQSA inspectors, FDA-approved accreditation body stakeholders, FDA-approved certifying agencies and FDA CDRH program offices through responses to inquires via email messages, phone calls, faxes and written communications pertaining to the MQSA program related matters.

Responses:

Responses to this notice should be sent to Thomas Lawson at Thomas.lawson@fda.hhs.gov NLT 5:00 pm (EDT), April 3, 2026.

This notice is not a request for competitive quotes. Any other firms desiring consideration must fully identify their interest and capability of meeting the requirements by submitting a capability statement. Any response shall undergo review to determine if it can meet the requirements. A determination by the Government not to compete this proposed requirement based upon a response to this notice is solely within the discretion of the Government.

View original listing