NCI OA Special Notice of Subcontract Opportunity at the Frederick National Laboratory for Cancer Research

This Special Notice is not a formal Invitation for Bid (IFB), Request for Proposal (RFP), Request for Quotation (RFQ) nor any type of Solicitation for offers. In accordance with FAR 15.201(d), this Special Notice is intended FOR INFORMATIONAL PURPOSES ONLY in order to publicize the requirements of the Frederick National Laboratory for Cancer Research (FNLCR).

The FNLCR is a Government-Owned Contractor-Operated Federally Funded Research and Development Center (FFRDC) located at Fort Detrick, Maryland. The FNLCR partners with university, Government, and corporate scientists to speed the translation of laboratory research into new diagnostic tests and treatments for cancer and AIDS. FNLCR is a multi-program laboratory currently operated by Leidos Biomedical Research, Inc. (Leidos Biomed) for the National Cancer Institute (NCI) under Prime Contract No. 75N91019D00024 & HHSN261201500003I, which provides Operations and Technical Support (OTS) for the FNLCR.

The Government assumes no liability for reimbursement for any effort or associated costs to respond, nor for any information provided as a result of this Special Notice as no information is being requested. Please be advised that any submissions provided, despite that no information is requested, become Government property and will not be returned, nor will there be any ensuing discussions or debriefings.

Responses submitted to this Special Notice are not offers and cannot be accepted by the U.S. Government to form a binding contract. It is the responsibility of the interested parties to monitor this site and any sites referenced herein for additional information pertaining to business opportunities within the FNLCR, if any.

Scope of Work: Leidos Biomed seeks subcontractor to provide guidance on bringing laboratory functions up to GCLP standards. This will include a thorough review of current laboratory practices, with identification of GCLP quality gaps or improvements, advice on GCLP compliance of sample management methods, critical GCLP quality components missing from standard operating procedures (SOPs), data management methods, equipment maintenance and calibration practices under GCLP, improved methods for assessing analyst competency for each assay and validating all software programs, including LIMS being utilized to capture, analyze, and store all laboratory generated data, according to GCLP.

Objectives and Project Requirements:

• Evaluation of gaps in the implementation of higher laboratory standards, GCLP, at the HPV Serology Laboratory, and conduct annual assessments to evaluate GCLP compliance to identify areas for improvement and advise on solutions to address gaps.


• Continue GCLP implementation and ensure compliance by external experts in GCLP with a long history in the GCLP field and strong track record in providing GCLP implementation services to NIH, particularly National Institute of Allergy and Infectious Diseases (NIAID) sponsored laboratories (or similar public health institutions).


• GCLP capabilities elevate the overall laboratory standards of quality by clearly defining the laboratory’s quality management system, including sample management, equipment maintenance, testing and data management. This will ensure testing and data integrity and will facilitate data review for recommendation and approval of new vaccine recommendations. The goal is to be able to generate reliable and well documented data that can accelerate decision-making towards new vaccine recommendations.


• Project will start with an initial visit by subcontractor for a thorough assessment of current laboratory operations, to identify gaps and areas for improvement around quality as relates specifically to GCLP. Subcontractor will perform gap analyses with a detailed list of action items for GCLP compliance, advise management and quality team in solutions to address gaps identified, assist in implementation of GCLP capabilities and development of QA management plan, and conduct annual assessments of compliance

Leidos Biomedical Research, Inc. Point of Contact for a copy of Solicitation/RFP No: S25-077:

Jennifer Gnuschke, Sr. Subcontracts Administrator, at jennifer.gnuschke@nih.gov