Clinical Materials Services   4

Project History:

Re-competition (Contract No.: HHSN272201700085C)

Current Contractor:

Fisher BioServices

20439 Seneca Meadows Parkway

Germantown, MD 20876

Project Description:

Research supported and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), strives to understand, treat and ultimately prevent the myriad of infectious, immunologic, and allergic diseases that threaten millions of human lives. The NIAID Division of Microbiology and Infectious Diseases (DMID) supports extramural research to control and prevent diseases caused by virtually all infectious agents other than Human Immunodeficiency Virus. This includes basic and applied research to develop and evaluate therapeutics, vaccines, and diagnostics, which is funded through a variety of research grants , cooperative agreements, and contracts.

The evaluation of new and improved vaccine, therapeutic, diagnostic and device candidates in clinical trials and clinical studies is an essential element of DMID's efforts. Through an extensive network of grants, cooperative agreements and contract research programs, DMID supports a broad range of clinical research, including single-site and multi-center Phase 1, Phase 2, and Phase 4 (and occasionally Phase 3) clinical trials for the evaluation of bacterial, viral and parasitic vaccines, other biologics, drugs, diagnostics and devices as preventive, therapeutic, diagnostic and device measures against infectious diseases in people of all ages and risk categories. Much of this clinical research is devoted to addressing critical public health needs, such as those related to emerging and re-emerging infectious diseases, including SARS-CoV-2, avian influenza and anti-microbial resistance, and those supporting the evaluation of safety and efficacy of vaccine and therapeutic candidates against potential agents of bioterrorism, including NIAID priority biodefense pathogens https://www.niaid.nih.gov/research/emerging-infectious-diseases-pathogens

In 2017, NIAID awarded a contract to Fisher BioServices Corporation (HHSN272201700085C) to provide for the operation of a Clinical Materials Services (CMS) facility that adheres to current Good Manufacturing Practice (cGMP), for the acquisition, receipt, storage and shipping of clinical agents and clinical specimens in support of DMID- sponsored clinical trials and research programs in the U.S. and abroad and ensures that all work performed is done in compliance with federal and/or local clinical trial related regulations. This solicitation is intended to recompete and continue these services.

Clinical agents include investigational study products (drugs, vaccines, therapeutics, diagnostics and devices), commercial products, placebos, syringes, and other protocol/Manual of Procedures (MOP)-mandated supplies to be used in DMID-sponsored clinical trials. Clinical specimens include sera or other protocol-mandated specimens obtained from DMID-approved clinical research sites, to be distributed or tested at DMID- approved testing laboratories.

Any awardee resulting from this solicitation will be transferred samples and data as part of initial transition activities. The Contractor shall be responsible for ALL work performed under this contract including that performed by any subcontractor(s).

It is anticipated that one (1) Cost-Reimbursement, Level-of-Effort type contract will be awarded for a one-year Base Period and six (6) Term Options and quantity options with the period of performance beginning on or about June 2022. It is estimated that 10 Full-Time equivalents (FTEs), based upon a work year of 20,325 hours including subcontractor and consultant personnel, will be required. If the Offeror's work year is less than the 20,325 hours, the Offeror must understand that the requirement is for the Contractor to provide the exact number of hours required per year for its proposal to be considered responsive. This information is furnished to Offerors for information purposes only and is not to be considered restrictive for proposal purposes.

Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about June 22, 2021, and may be accessed through beta.SAM.gov. Beta.SAM.gov connects to the NIAID electronic Contract Proposal Submission (eCPS) website (ALL R&D solicitations MUST be in eCPS). For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit.

This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.