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This Government Contract opportunity from Department Of Health And Human Services was posted on September 5, 2024. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Intent to Sole Source-OPQR St. Louis ISO Accreditation

Awarded
75F40124Q00515Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

General Info

NAICS

N/A

Place of Performance

Saint Louis, MO, 63110, USA

Set-Aside

NONE

Documents

1

OPQR St. Louis ISO Accreditation Justification

PDF, Low priorityjustification-and-authorization
Low

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Timeline

PhaseAwarded
Posted

special-notice

Awarded

Contract was awarded

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs
Contacts1 person available
OfficeBeltsville, MD, 20705, USA
Office AddressBeltsville, MD, 20705, USA
Contacts
Natalie Brown

Full Description

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The Government intends to negotiate and solicit with only one source American Association for Laboratory Accreditation (A2LA), 5202 Presidents Court, Suite 220 Frederick, MD 21703 to obtain a third-party vendor to provide auditing services for an unbiased assessment and certification of the OPQR St. Louis quality management system and lab under the authority of FAR (13.106(b)(1)(i). This is not a request for competitive proposals; however, any responsible offeror may submit a quote which will be given due consideration by the agency. This acquisition is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-06. For purposes of this acquisition, the associated NAICS code is 813920. The small business size standard is $23.5M. This action is being solicited as a sole source. Line-Item Structure: The following is a list of line-item number(s) and items, quantities, and units of measure, (including option(s), if applicable) and should be reflected in the Offeror's quote/proposal: Description of Deliverable Quantity Price Line Item 0001: OPQR St. Louis ISO Accreditation - Base Year 1 Line Item 0002: OPQR St. Louis ISO Accreditation - Option 1 1 Line Item 0003: OPQR St. Louis ISO Accreditation - Option 2 1 Line Item 0004: OPQR St. Louis ISO Accreditation - Option 3 1 Line Item 0005: OPQR St. Louis ISO Accreditation - Option 4 1 Specifications/Requirement: OPQR St. Louis ISO Accreditation. Place of Performance/Delivery Location Audits will be performed for the site at the following addresses: U.S Food and Drug Administration Center for Drug Evaluation and Research / Office of Pharmaceutical Quality Research 645 Newstead Ave., St Louis, MO 63110

More opportunities from Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

Same awarding agency

NAICS: 541611
New
Federal
Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ
Solicitation # 75F40126R00009
Solicitation 75F40126R00009 is a request for proposals for a single Indefinite Delivery, Indefinite Quantity (IDIQ) contract to provide Contractor-Hosted Fully Integrated Records Facility (FIRF) services for the FDA. This acquisition is exclusively set aside for Service-Disabled Veteran-Owned Small Business (SDVOSB) concerns under NAICS code 541611. The contract features a five-year ordering period from December 1, 2026, through November 30, 2031, with an additional six-month option to extend services. The IDIQ has a maximum ceiling of 50 million dollars and a guaranteed minimum of 10,000 dollars. Task orders may be issued as Time-and-Materials, Labor-Hour, Firm-Fixed Price, or a combination thereof. The scope of work involves providing personnel, materials, and facilities for offsite document control services, with a strategic goal of transitioning to a near 100 percent electronic environment for premarket and postmarket submissions. Key responsibilities include program management, document processing, data and stakeholder support, and records management. Award will be made on a Lowest Price-Technically Acceptable (LPTA) basis, with technical factors and past performance evaluated as acceptable or unacceptable. Proposals are due by 2:00 PM Eastern Time on October 29, 2026, and must be submitted in three separate volumes, strictly adhering to formatting and file type restrictions to avoid being deemed non-responsive.
Administrative Management and General Management Consulting Services

POSTED

2 days ago

DEADLINE

in 8 days
View Details

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