Division of Microbiology and Infectious Diseases (DMID) Clinical Materials Services
Added: Sep 01, 2016 5:38 pm
Type of Requirement:Re-competition (Contract No.: HHSN272200800044C)Current Contractor:Fisher BioServices14665 Rothgeb DriveRockville, MD 20850Contracting Office Address:Department of Health and Human Services, National Institutes of Health, National Institutes of Allergy and Infectious Diseases, Office of Acquisitions, 5601 Fishers Lane, MSC 9821, Bethesda, MD, 20892- 9821Duration of contract:Base Period of twelve months, plus four (4) twelve month option terms, for a maximum period of performance of five (5) years.Options for additional services/quantities under the contract may be exercised at the discretion of the Government and are defined as follows:Option Periods:The Government may extend the contract period of the performance in one-year terms beyond the contract base period. The total period of performance resulting from the base period plus all potential options is five years. If an option period is exercised, the services required will be within the same scope as those provided during the base year.Option Quantities:The Government may exercise options for increases in the level of effort. For each option quantity exercised, the Contractor shall provide an additional 11,180 labor hours. An option quantity may be exercised not more than twice within each contract year, as needed. If an option quantity is exercised, the services required will be within the same scope as those provided for the base level of effort requirement.Anticipated award date: On or about April 1, 2017Presolicitation Notice Information:IntroductionThe National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), of the Department of Health and Human Services (DHHS) supports research related to the basic understanding of microbiology and immunology leading to the development of vaccines, therapeutics, and medical diagnostics for the prevention, treatment, and diagnosis of infectious and immune-mediated diseases. The NIAID Division of Microbiology and Infectious Diseases has a requirement for clinical agent and clinical specimen repository support.DescriptionResearch 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 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 grant 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 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 (http://www3.niaid.nih.gov/Biodefense/bandc_priority.htm).In August 2008, NIAID awarded a 7-year contract to Fisher BioServices Corporation (HHSN272200800044C) to provide for the operation of a Clinical Agent and Specimen Repository (CASR) 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. NIAID recognizes that a single organization or institution may not have the expertise and facilities required to perform all of the activities set forth in the Statement of Work and, consequently, that the Contractor may need to be supported to a certain extent by the expertise and resources of subcontractors to perform some of the tasks required. 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 four (4) Term Options with the period of performance beginning on or about April 1, 2017. It is estimated that approximately 11 Full-Time equivalents (FTEs), based upon a work year of 2,080 hours including subcontractor and consultant personnel, will be required. If the Offeror's work year is less than the 2,080 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 September 19, 2016 and may be accessed through FedBizOpps http://www.fedbizopps.gov/ . This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted.For this solicitation, the NIAID requires proposals to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) website. Submission of proposals by facsimile or e-mail is not acceptable.For directions on using eCPS, go to the website https://ecps.nih.gov/NIAID and then click on "How to Submit."
NIAID-DMID-NIHAI2016065 Department of Health and Human Services National Institutes of Health
9/1/16, 5:38 PM