Immune-Mediated Diseases Clinical Products Center

Amendment One Changes to the RFP 1. Proposals are due on December 4, 2017. 2. Attachment 3, Statement of Work, page 2, paragraph 1, "c. Other NIAID-funded clinical trials on an as-needed basis." is changed to "b. Other NIAID-funded clinical trials on an as-needed basis." Introduction The 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 Allergy, Immunology, and Transplantation (DAIT) has a requirement for a clinical products center that will obtain, store, and deliver investigational agents to the appropriate clinical trials sites and personnel for DAIT-supported clinical trials, primarily those conducted by the Immune Tolerance Network (ITN). The center will be a central location for the receipt, storage, repackaging, labeling, and distribution of study products in accordance with federal regulations governing investigational agents. Description Research supported and conducted by NIAID, NIH, DHHS, strives to better understand, treat, and ultimately prevent immunologic, infectious, and allergic diseases. DAIT supports extramural basic, pre-clinical and clinical research focusing on immune-mediated diseases through a variety of research grants and contracts. This includes support for clinical research programs and individual research projects to evaluate the safety and efficacy of therapeutic and preventive approaches and agents and to elucidate the underlying mechanisms of such approaches and agents. In FY 2012 a 7-year contract was awarded to Eminent Services Corporation in Frederick, Maryland to establish the "Clinical Distribution Center" (Contract No. HHSN272201200001C). This contract provides DAIT with centralized services for the receipt, storage, packaging/repackaging, manufacture of placebo, preparation of serial dilutions, labeling, distribution, inventory and disposal of study products for clinical trials conducted by DAIT. The purpose of this contract is to continue these services for DAIT and expand the scope of services provided to include DAIT and NIAID-supported, investigator-initiated clinical trials conducted under cooperative agreement grants, as well as other DAIT-funded clinical research programs on a limited, as-needed basis. The following three Mandatory Qualification Criteria (MQC) must be met at the time of receipt of the Original Proposal; 1.) Offerors must have a permit to purchase and distribute drug products; 2.) staff must include a licensed pharmacist able to purchase and distribute drug products and; 3.) offerors must currently have or have had within the past 12 months the appropriate permits and/or licenses to import and export drug products. TECHNICAL EVALUATION CRITERIA: CRITERIA WEIGHT 1: TECHNICAL PLAN/APPROACH 60 2: SCIENTIFIC AND TECHNICAL PERSONNEL 20 3: FACILITIES, EQUIPMENT AND OTHER RESOURCES 10 4: PROJECT MANAGEMENT 10 TOTAL POSSIBLE WEIGHT: 100 It is anticipated that a level of effort type contract will be awarded. The Government estimates the effort to perform the base requirements of the Statement of Work (Year 1 and Options 1-6 - Years 2 through 7) to be approximately 3.85 full time equivalents (FTEs) per year. Additionally, the anticipated contract award will contain options for increased levels of effort in increments of 5% over the base requirement which can be exercised up to 5 times per contract year. Any responsible offeror may submit a proposal which will be considered by the Agency. This RFP will be available electronically on/about August 31, 2017, 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 via two methods: (1) Disc (CD or DVD) and (2) Online via the NIAID electronic Contract Proposal Submission (eCPS) website. The content of the disc and online proposals must be identical. Submission of proposals by facsimile or e-mail is not acceptable. For directions on using eCPS, go to the website https://ecps.nih.gov and then click on "How to Submit."?