Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF DECEMBER 17, 2023 SAM #8055
SOLICITATION NOTICE

Q -- Accreditation of CBER�s Laboratory Quality System and Reference Materials Production

Notice Date

12/15/2023 11:20:20 AM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541380 — Testing Laboratories
 

Contracting Office

FDA OFFICE OF ACQ GRANT SVCS Beltsville MD 20705 USA
 

ZIP Code

20705
 

Solicitation Number

75F40124R00024
 

Response Due

1/15/2024 12:00:00 PM
 

Archive Date

01/30/2024
 

Point of Contact

Sheila Brown, Ian Weiss, Phone: 3017965728
 

E-Mail Address

Sheila.Brown1@fda.hhs.gov, Ian.Weiss@fda.hhs.gov
(Sheila.Brown1@fda.hhs.gov, Ian.Weiss@fda.hhs.gov)
 

Small Business Set-Aside

SBA Total Small Business Set-Aside (FAR 19.5)
 

Description

Solicitation number FDA-RFP - 75F40124R00024 is issued as a Request for Proposal (RFP). This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information from FAR Part 13 and included in this notice. The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 2023-03. The North American Industrial Classification System (NAICS) code for this procurement is 541380, Testing Laboratories. The PSC Code will be PSC Q301 Medical�Laboratory Testing. The objective of this contract is to renew accreditation of CBER�s pharmaceutical testing and reference material production activities to international standard ISO 17025 �General requirements for the competence of testing and calibration laboratories� and ISO 17034 �General requirements for the competence of reference material producers�.�After accreditation is granted, an alternating schedule of biennial on-site assessments and alternating year document reviews is required. Independently, and not as an agent of the Government, the Contractor shall assess CBER�s 17025 and 17034 Quality System and LQS including previously accredited biological, microbiological, and chemical test methods (currently 21) with no additional new test methods being put forward for the base year but CBER reserves the right to expand its scope in the upcoming option years (approximately 10 per year) along with approximately 30 reference materials.� These activities are conducted at only one location in Silver Spring, Maryland.� No off-site or mobile testing is performed.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/d9fdecce1c3c4a0697eae57aabc76d46/view)
 

Place of Performance

Address: Chevy Chase, MD 20815, USA

Zip Code: 20815

Country: USA
 

Record

SN06913781-F 20231217/231215230041 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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