Good clinical laboratory practices, gclp, inspection and certification (ambis 2210099)

This notice is a combined synopsis/solicitation for commercial items using Simplified Acquisition Procedures. This acquisition will be made in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 “Streamlined Procedures for Evaluation and solicitation for commercial Items,” as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation (a written solicitation will not be issued) and quotes are being requested. The Solicitation number is RFQ-NIAID-24-2210099 and the solicitation is issued as a Request for Quotes (RFQ).

This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures (SAP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-03, February 23, 2024.

The National Institutes of Health (NIH), National Institute of Allergy and Infectious Disease (NIAID), Vaccine Immunology Program (VIP) aids the Vaccine Research Center (VRC) by supporting the development of monoclonal antibodies and vaccines for infectious diseases such as HIV, Influenza, Ebola, and more recently SARS-CoV-2 Coronavirus. Support is through the state-of-the-art laboratory performing pre­ clinical as well as Phase 1 and Phase 3 clinical end point testing to inform further study designs, research questions and vaccine modification and design. To be compliant with FDA guidelines for phase 3 testing, the VIP must maintain CFR 21 part 11 compliance, which includes the inspection of the facilities, processes and testing methods to be considered Good Clinical Laboratory Practice (GCLP) compliant.

The VIP has a current requirement for inspection services for GCLP compliance and certification. Current certification expires in quarter one (1) of 2024. The objective is to renew the lab’s compliance certificate.

PROJECT DESCRIPTION:

Inspection and audit of Guidelines on Good Clinical Laboratory Practice (GCLP) areas, procedures, equipment and training records for compliance and certificate.

The current requirements are as follows:

#

Description

Qty

1

GCLP Compliance Inspection & Certification

1

PLEASE SEE STATEMENT OF WORK (SOW) WITH FULL DETAILS.

Quoting Instructions: 

•DUE TO THE SENSITIVE NATURE OF THE PROJECTS, SERVICES PROVIDED MUST BE OF EQUAL SERVICE PROVIDED UNDER GCLP INSPECTION AND CERTIFICATION COMPLIANCE.

•ALL OFFERORS MUST INCLUDE GCLP CERTIFICATION DOCUMENTATION AS A DEALER /SERVICE PROVIDER FOR GLCP INSPECTION AND CERTIFICATION QUOTES TO BE CONSIDERED.

PLACE OF PERFORMANCE:  NIH/NIAID/VIP, 9 West Watkins Mill Road, Gaithersburg, MD 20878.

DELIVERY DATE:  Estimate 90 days after receipt and acceptance of award.

The government intends to award a FIRM FIXED PRICE purchase order to the responsible contractor as a result of this RFQ that will include the terms and conditions set forth herein.  The award will be based on the following: technical capability to meet the requirements and price.

The following FAR provisions apply to this acquisition:

FAR 52.212-1 Instructions to Offerors Commercial Items (SEP 2023)

FAR 52.212-3 Offerors Representations and Certifications - Commercial Items (FEB 2024)

FAR 52.204-7 System for Award Management (OCT 2018)

(Offerors must complete annual representations and certifications on-line at http://www.sam.gov/ in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items (Please ensure FAR 52.209-2 -- Prohibition on Contracting with Inverted Domestic Corporations--Representation. (Nov 2015) is updated in your SAM record)

FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements – Representation (JAN 2017)

FAR 52.204–26 Covered Telecommunications Equipment or Services-Representation

(OCT 2020) *** Must complete representation if attached to this solicitation- see attachment 52.204-26

The following FAR contract clauses apply to this acquisition:

FAR 52-212-4 Contract Terms and Conditions Commercial Items (NOV 2023)

FAR 52-212.5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (FEB 2024)

*The applicable subparagraphs of FAR52.212-5 are included in the attachment to this posting.

FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (MAR 2023)

FAR 52.204-13 System for Award Management Maintenance (OCT 2018)

FAR 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (NOV 2021)

HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (DEC 2015)

52.252-2 -- Clauses Incorporated by Reference. (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address:  http://farsite.hill.af.mil/vffara.htm

By submission of an offer, the offeror acknowledges the requirement that a prospective awardee shall be registered in the System for Award Management (SAM) database prior to award, during performance, and through final payment of any contract, basic agreement, basic ordering agreement, or blanket purchasing agreement resulting from this solicitation (www.sam.gov).

Copies of the above-referenced provisions and clauses are available from http://www.acquisition.gov/far/loadmainre.html & http: //www.hhs.gov/regulation/index.html or, upon request, either by telephone or fax.

Submission shall be received not later than March 14, 2024 @ 11:00 AM EST

Offers may be e-mailed to Rita Davis (E-Mail/rita.davis@nih.gov). Offers shall include RFQ number in the subject line (RFQ-NIAID-24-2210099). Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f)

All responsible sources may submit an offer that will be considered by this Agency. 

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to Rita Davis @ rita.davis@nih.gov.